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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
Showing 1 - 200 of 253 Journals sorted by number of followers
Nature Reviews Drug Discovery     Full-text available via subscription   (Followers: 332)
International Journal of Drug Policy     Hybrid Journal   (Followers: 254)
Journal of Clinical Oncology     Hybrid Journal   (Followers: 242)
Journal of Medicinal Chemistry     Hybrid Journal   (Followers: 157)
Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 155)
Drugs     Full-text available via subscription   (Followers: 146)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 98)
Pharmaceutical Research     Hybrid Journal   (Followers: 94)
European Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 86)
Drug Safety     Full-text available via subscription   (Followers: 83)
Annals of Pharmacotherapy     Hybrid Journal   (Followers: 56)
Biomaterials     Hybrid Journal   (Followers: 54)
Clinical Pharmacology & Therapeutics     Hybrid Journal   (Followers: 44)
Regulatory Toxicology and Pharmacology     Hybrid Journal   (Followers: 42)
Journal of Controlled Release     Hybrid Journal   (Followers: 38)
Annual Review of Pharmacology and Toxicology     Full-text available via subscription   (Followers: 38)
International Journal of Pharmaceutics     Hybrid Journal   (Followers: 37)
Clinical Therapeutics     Hybrid Journal   (Followers: 34)
European Journal of Pharmaceutics and Biopharmaceutics     Hybrid Journal   (Followers: 34)
Pharmacoepidemiology and Drug Safety     Hybrid Journal   (Followers: 33)
British Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 32)
Journal of Pharmacy and Pharmacology     Full-text available via subscription   (Followers: 31)
Drug Development and Industrial Pharmacy     Hybrid Journal   (Followers: 29)
PharmacoEconomics     Full-text available via subscription   (Followers: 27)
Clinical Pharmacokinetics     Full-text available via subscription   (Followers: 27)
AAPS Journal     Hybrid Journal   (Followers: 26)
Critical Reviews in Toxicology     Hybrid Journal   (Followers: 25)
Journal of Clinical Psychopharmacology     Hybrid Journal   (Followers: 24)
International Journal of Pharmacy Practice     Full-text available via subscription   (Followers: 24)
Toxicology and Applied Pharmacology     Hybrid Journal   (Followers: 24)
Chemical Research in Toxicology     Hybrid Journal   (Followers: 22)
Journal of Pharmacokinetics and Pharmacodynamics     Hybrid Journal   (Followers: 22)
Journal of Pain & Palliative Care Pharmacotherapy     Hybrid Journal   (Followers: 21)
Trends in Pharmacological Sciences     Full-text available via subscription   (Followers: 20)
Journal of Applied Toxicology     Hybrid Journal   (Followers: 19)
Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 19)
Pharmaceutical Development and Technology     Hybrid Journal   (Followers: 19)
American Journal of Cardiovascular Drugs     Hybrid Journal   (Followers: 19)
Clinical Trials     Hybrid Journal   (Followers: 18)
Toxicology     Hybrid Journal   (Followers: 18)
Journal of Pharmaceutical and Biomedical Analysis     Hybrid Journal   (Followers: 18)
Clinical Toxicology     Hybrid Journal   (Followers: 18)
International Journal of Toxicology     Hybrid Journal   (Followers: 17)
Critical Reviews in Clinical Laboratory Sciences     Hybrid Journal   (Followers: 16)
Journal of Clinical Pharmacy and Therapeutics     Hybrid Journal   (Followers: 16)
Journal of Natural Products     Hybrid Journal   (Followers: 16)
Pharmaceutical Statistics     Hybrid Journal   (Followers: 15)
Toxicology Letters     Hybrid Journal   (Followers: 15)
Journal of Pharmacy Practice     Hybrid Journal   (Followers: 15)
Psychopharmacology     Hybrid Journal   (Followers: 15)
Basic & Clinical Pharmacology & Toxicology     Hybrid Journal   (Followers: 14)
Cardiovascular Drugs and Therapy     Hybrid Journal   (Followers: 14)
European Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 14)
Current Medicinal Chemistry     Hybrid Journal   (Followers: 13)
American Journal of Therapeutics     Hybrid Journal   (Followers: 13)
Drug and Chemical Toxicology     Hybrid Journal   (Followers: 13)
Journal of the American Pharmacists Association     Full-text available via subscription   (Followers: 13)
Clinical Research and Regulatory Affairs     Hybrid Journal   (Followers: 12)
Seminars in Hematology     Hybrid Journal   (Followers: 12)
Drug Discovery Today: Technologies     Full-text available via subscription   (Followers: 12)
Current Pharmaceutical Design     Hybrid Journal   (Followers: 12)
Journal of Oncology Pharmacy Practice     Hybrid Journal   (Followers: 12)
Journal of Psychopharmacology     Hybrid Journal   (Followers: 11)
Biopharmaceutics and Drug Disposition     Hybrid Journal   (Followers: 11)
Toxicology in Vitro     Hybrid Journal   (Followers: 11)
Drug Development Research     Hybrid Journal   (Followers: 11)
Drug Metabolism and Disposition     Hybrid Journal   (Followers: 11)
Seminars in Oncology Nursing     Full-text available via subscription   (Followers: 10)
Biochemical Pharmacology     Hybrid Journal   (Followers: 10)
Journal of Separation Science     Hybrid Journal   (Followers: 10)
CNS Drugs     Full-text available via subscription   (Followers: 10)
Current Pharmaceutical Biotechnology     Hybrid Journal   (Followers: 10)
Journal of Medical Marketing     Hybrid Journal   (Followers: 10)
Drugs & Aging     Full-text available via subscription   (Followers: 10)
European Neuropsychopharmacology     Hybrid Journal   (Followers: 9)
Food Additives & Contaminants Part A     Hybrid Journal   (Followers: 9)
Journal of Pharmacology and Experimental Therapeutics     Hybrid Journal   (Followers: 9)
Environmental Toxicology and Pharmacology     Hybrid Journal   (Followers: 9)
Medicinal Chemistry     Hybrid Journal   (Followers: 9)
Biometrical Journal     Hybrid Journal   (Followers: 9)
Drugs & Therapy Perspectives     Full-text available via subscription   (Followers: 9)
Prescriber     Hybrid Journal   (Followers: 9)
ChemMedChem     Hybrid Journal   (Followers: 9)
Current Opinion in Pharmacology     Hybrid Journal   (Followers: 9)
European Journal of Pharmacology     Hybrid Journal   (Followers: 8)
Inhalation Toxicology     Hybrid Journal   (Followers: 8)
Antiviral Research     Hybrid Journal   (Followers: 8)
Drug Metabolism Reviews     Hybrid Journal   (Followers: 8)
Progress in Neuro-Psychopharmacology and Biological Psychiatry     Hybrid Journal   (Followers: 8)
Human & Experimental Toxicology     Hybrid Journal   (Followers: 8)
Drug Delivery     Open Access   (Followers: 8)
BioDrugs     Full-text available via subscription   (Followers: 8)
Frontiers in Drug Design & Discovery     Hybrid Journal   (Followers: 8)
Expert Review of Pharmacoeconomics & Outcomes Research     Full-text available via subscription   (Followers: 8)
Experimental and Clinical Psychopharmacology     Full-text available via subscription   (Followers: 7)
Toxicology Mechanisms and Methods     Hybrid Journal   (Followers: 7)
Journal of Pharmacological and Toxicological Methods     Hybrid Journal   (Followers: 7)
Clinical and Experimental Pharmacology and Physiology     Hybrid Journal   (Followers: 7)
Scandinavian Journal of Clinical and Laboratory Investigation     Hybrid Journal   (Followers: 7)
Epilepsy Research     Hybrid Journal   (Followers: 7)
Clinical Drug Investigation     Full-text available via subscription   (Followers: 7)
Journal of Veterinary Pharmacology and Therapeutics     Hybrid Journal   (Followers: 6)
Toxicology and Industrial Health     Hybrid Journal   (Followers: 6)
Skin Pharmacology and Physiology     Full-text available via subscription   (Followers: 6)
Journal of Cardiovascular Pharmacology     Hybrid Journal   (Followers: 6)
AAPS PharmSciTech     Hybrid Journal   (Followers: 6)
Current Drug Discovery Technologies     Hybrid Journal   (Followers: 6)
Current Drug Delivery     Hybrid Journal   (Followers: 6)
Current Therapeutic Research     Open Access   (Followers: 6)
Expert Review of Cardiovascular Therapy     Full-text available via subscription   (Followers: 6)
Neuropharmacology     Hybrid Journal   (Followers: 5)
Current Drug Metabolism     Hybrid Journal   (Followers: 5)
Fitoterapia     Hybrid Journal   (Followers: 5)
Expert Review of Molecular Diagnostics     Full-text available via subscription   (Followers: 5)
Expert Review of Anti-infective Therapy     Full-text available via subscription   (Followers: 5)
Anti-Infective Agents     Hybrid Journal   (Followers: 5)
Toxicon     Hybrid Journal   (Followers: 5)
Medicinal Research Reviews     Hybrid Journal   (Followers: 5)
Investigational New Drugs     Hybrid Journal   (Followers: 5)
Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry     Hybrid Journal   (Followers: 5)
Current Cancer Therapy Reviews     Hybrid Journal   (Followers: 5)
Reviews of Physiology, Biochemistry and Pharmacology     Hybrid Journal   (Followers: 4)
Planta Medica     Hybrid Journal   (Followers: 4)
Current Vascular Pharmacology     Hybrid Journal   (Followers: 4)
Pharmaceutical Medicine     Full-text available via subscription   (Followers: 4)
Journal of Child and Adolescent Psychopharmacology     Hybrid Journal   (Followers: 4)
CNS Drug Reviews     Open Access   (Followers: 4)
Inpharma Weekly     Full-text available via subscription   (Followers: 4)
Journal of Labelled Compounds and Radiopharmaceuticals     Hybrid Journal   (Followers: 4)
Immunopharmacology and Immunotoxicology     Hybrid Journal   (Followers: 4)
International Journal of Pharmaceutical and Healthcare Marketing     Hybrid Journal   (Followers: 4)
Inflammation Research     Hybrid Journal   (Followers: 4)
Cancer Chemotherapy and Pharmacology     Hybrid Journal   (Followers: 4)
International Journal of Neuropsychopharmacology     Open Access   (Followers: 3)
Pharmacology & Therapeutics     Hybrid Journal   (Followers: 3)
Physiology International     Full-text available via subscription   (Followers: 3)
Cardiovascular Therapeutics     Open Access   (Followers: 3)
ASSAY and Drug Development Technologies     Hybrid Journal   (Followers: 3)
Pharmacopsychiatry     Hybrid Journal   (Followers: 3)
Chemotherapy     Full-text available via subscription   (Followers: 3)
Therapeutic Drug Monitoring     Hybrid Journal   (Followers: 3)
Current Drug Therapy     Hybrid Journal   (Followers: 3)
Research in Social and Administrative Pharmacy     Hybrid Journal   (Followers: 3)
PharmacoEconomics & Outcomes News     Full-text available via subscription   (Followers: 3)
Journal of Aerosol Medicine and Pulmonary Drug Delivery     Hybrid Journal   (Followers: 3)
Journal of Ethnopharmacology     Hybrid Journal   (Followers: 3)
Drug Resistance Updates     Hybrid Journal   (Followers: 3)
Journal of Pain Management & Medicine     Open Access   (Followers: 3)
Journal of Infection and Chemotherapy     Hybrid Journal   (Followers: 3)
Journal of Cardiovascular Pharmacology and Therapeutics     Hybrid Journal   (Followers: 3)
Current Pharmacogenomics and Personalized Medicine     Hybrid Journal   (Followers: 3)
Acta Pharmacologica Sinica     Hybrid Journal   (Followers: 3)
Microbial Drug Resistance     Hybrid Journal   (Followers: 3)
Frontiers in Medicinal Chemistry     Hybrid Journal   (Followers: 3)
Human Psychopharmacology Clinical and Experimental     Hybrid Journal   (Followers: 3)
BMC Pharmacology     Open Access   (Followers: 2)
The Brown University Psychopharmacology Update     Hybrid Journal   (Followers: 2)
International Clinical Psychopharmacology     Hybrid Journal   (Followers: 2)
Canadian Journal of Physiology and Pharmacology     Hybrid Journal   (Followers: 2)
Journal of Drug Targeting     Hybrid Journal   (Followers: 2)
Inflammopharmacology     Hybrid Journal   (Followers: 2)
Journal of Inflammation     Open Access   (Followers: 2)
Fundamental & Clinical Pharmacology     Hybrid Journal   (Followers: 2)
Behavioural Pharmacology     Hybrid Journal   (Followers: 2)
Vascular Pharmacology     Hybrid Journal   (Followers: 2)
Pulmonary Pharmacology & Therapeutics     Hybrid Journal   (Followers: 2)
Biomedicine & Pharmacotherapy     Full-text available via subscription   (Followers: 2)
Clinical Neuropharmacology     Hybrid Journal   (Followers: 2)
Drugs in R & D     Full-text available via subscription   (Followers: 2)
International Immunopharmacology     Hybrid Journal   (Followers: 2)
Pharmacology Biochemistry and Behavior     Hybrid Journal   (Followers: 2)
Letters in Drug Design & Discovery     Hybrid Journal   (Followers: 2)
Archiv der Pharmazie     Hybrid Journal   (Followers: 2)
Pharmacological Reviews     Hybrid Journal   (Followers: 2)
Molecular Pharmacology     Hybrid Journal   (Followers: 2)
Journal of Microencapsulation: Microcapsules, Liposomes, Nanoparticles, Microcells, Microspheres     Hybrid Journal   (Followers: 2)
Toxicological & Environmental Chemistry     Hybrid Journal   (Followers: 2)
Particulate Science and Technology: An International Journal     Hybrid Journal   (Followers: 1)
Pharmacological Research     Hybrid Journal   (Followers: 1)
Current Enzyme Inhibition     Hybrid Journal   (Followers: 1)
Journal of Neuroimmune Pharmacology     Hybrid Journal   (Followers: 1)
Current Pharmaceutical Analysis     Hybrid Journal   (Followers: 1)
Current Neuropharmacology     Hybrid Journal   (Followers: 1)
Pharmacogenetics and Genomics     Hybrid Journal   (Followers: 1)
Journal of Texture Studies     Hybrid Journal   (Followers: 1)
Pharmaceutical Biology     Open Access  
Journal of Liposome Research     Hybrid Journal  
Toxin Reviews     Hybrid Journal  
Kaohsiung Journal of Medical Sciences     Open Access  
Redox Report     Open Access  
Pharmacology     Full-text available via subscription  
Pharmaceutical Chemistry Journal     Hybrid Journal  
NeuroMolecular Medicine     Hybrid Journal  
Journal of Ocular Pharmacology and Therapeutics     Hybrid Journal  
Harm Reduction Journal     Open Access  
Current Nanoscience     Hybrid Journal  
Infectious Disorders - Drug Targets     Hybrid Journal  
Current Bioactive Compounds     Hybrid Journal  
Cancer Biotherapy & Radiopharmaceuticals     Hybrid Journal  
Autonomic & Autacoid Pharmacology     Hybrid Journal  

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Similar Journals
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Annals of Pharmacotherapy
Journal Prestige (SJR): 1.096
Citation Impact (citeScore): 2
Number of Followers: 56  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 1060-0280 - ISSN (Online) 1542-6270
Published by Sage Publications Homepage  [1175 journals]
  • Comment: Analysis of Bicarbonate-Based Purge Solution in Patients With
           Cardiogenic Shock Supported Via Impella Ventricular Device

    • Free pre-print version: Loading...

      Authors: Jeremy D. Moretz, Scott Corbett, Seth Bilazarian
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-12-02T11:38:21Z
      DOI: 10.1177/10600280221139458
       
  • Practical Challenges With the Implementation of First-Order
           Pharmacokinetic Analytic Equations for AUC Monitoring for Vancomycin

    • Free pre-print version: Loading...

      Authors: Madison E. Salam, Cynthia T. Nguyen, Randall W. Knoebel, Natasha N. Pettit
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-12-01T12:48:37Z
      DOI: 10.1177/10600280221139242
       
  • Comparison of Open-Access, Trough-Only Online Calculators Versus
           Trapezoidal Method for Calculation of Vancomycin Area Under the Curve
           (AUC)

    • Free pre-print version: Loading...

      Authors: Elizabeth Keil, Rebekah H. Wrenn, Connor R. Deri, Cara N. Slaton, Jenny Shroba, Alice Parish, Alaattin Erkanli, Justin Spivey
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Vancomycin area-under-the-curve (AUC) monitoring is associated with reduced nephrotoxicity but may increase cost and workload for personnel compared to trough monitoring.Objective:The purpose of this study was to compare the accuracy of vancomycin AUC calculated by open-access, online, trough-only calculators to AUCs calculated by the trapezoidal method (TM) using peak and trough concentrations.Methods:This retrospective, multi-center study included adults ≥18 years old with stable renal function who received vancomycin with steady-state peak and trough concentrations. Areas under the curve calculated by TM were compared to AUCs calculated by 3 online calculators using trough-only options for calculation: ClinCalc, VancoVanco, and VancoPK. The primary outcome was actual difference in AUC between TM and the online calculators. Secondary outcomes were percent difference in AUC and clinical alignment in dose adjustments between methods.Results:Seventy patients were included for analysis. There was a statistically significant difference in AUC between TM and ClinCalc (median actual difference: −52, P < 0.001) and VancoVanco (median actual difference: 95, P < 0.001), whereas there was no significant difference between TM and VancoPK (median actual difference: −0.8, P = 0.827). Discordant dose adjustments were indicated when comparing ClinCalc, VancoVanco, and VancoPK to TM in 28%, 36%, and 12% of cases, respectively.Conclusion:The AUC calculator most closely aligned with TM was VancoPK, whereas other included calculators were statistically different. Owing to the cost and complexity of obtaining multiple levels, our findings support using a single steady-state trough using VancoPK as an alternative to TM for calculation of vancomycin AUC.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-12-01T12:36:37Z
      DOI: 10.1177/10600280221138867
       
  • A Review of Topical Roflumilast for the Treatment of Plaque Psoriasis

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      Authors: Jessica N. Pixley, Taylor Schaetzle, Steven R. Feldman
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:This article reviews clinical trials to assess the efficacy, safety, and clinical application of once-daily roflumilast 0.3% cream for the treatment of plaque psoriasis.Data sources:A systematic review of the literature was performed using the terms roflumilast OR Zoryve OR ARQ-151 in MEDLINE (PubMed) and EMBASE databases between January 2012 and October 2022. Bibliographies and the ClinicalTrials.gov website were also searched to identify further studies.Study selection and data extraction:Studies written in English and relevant to pharmacology, clinical trials, and safety were considered for inclusion.Data synthesis:In two 8-week phase III clinical trials, disease severity as assessed by a score of “clear” or “almost clear” and a 2-point improvement on Investigator Global Assessment (IGA) was 42.4% and 37.5% at week 8 in DERMIS-1 and DERMIS-2, respectively, compared to 6.1% and 6.9% in the control groups. In the 52-week phase III trial, treatment success rates for plaque psoriasis and intertriginous psoriasis were similar to the 8-week data with 45% of patients in the treatment group were evaluated as an IGA of “clear” or “almost clear” at week 52.Relevance to patient care and clinical practice in comparison to existing drugs:Roflumilast is a new US Food and Drug Administration (FDA)-approved topical phosphodiesterase inhibitor that shows promise for the treatment of mild-severe plaque psoriasis. It is an effective and safe topical nonsteroidal alternative to currently available topical corticosteroids, but there are currently no comparative studies with other psoriasis treatments.Conclusion:Roflumilast is effective and safe for the treatment of plaque psoriasis and intertriginous psoriasis. Future trials should compare its efficacy and tolerability with that of the older, clinically established topical corticosteroids. Prohibitive factors may include limited patient adherence to topical treatments and cost.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-24T12:33:29Z
      DOI: 10.1177/10600280221137750
       
  • “N-Acetylcysteine for Obsessive-Compulsive and Related Disorders in
           Children and Adolescents: A Review”

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      Authors: Gabrielle M. Parli, Mark A. Gales, Barry J. Gales
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To evaluate clinical data using oral n-acetylcysteine (NAC) in obsessive-compulsive and related disorders (OCDRD) treatment.Data Sources:PubMed, Ovid MEDLINE (1946-July 2022), and the Cochrane Library database were searched using the terms NAC, children, adolescent, obsessive-compulsive disorder (OCD), trichotillomania (TTM), excoriation, hoarding disorder, and body dysmorphic disorder. Bibliographies were reviewed for relevant trials and case studies.Study Selection and Data Extraction:English language, clinical trials, or case studies analyzing NAC use in patients aged 3 to 21 years old with OCDRD as determined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.Data Synthesis:Three randomized double-blind placebo-controlled trials of NAC in children and adolescents studied 121 patients with OCDRD. Trials assessed symptom severity from baseline to 10 to 12 weeks of NAC therapy. Two OCD trials identified statistically significant improvements, with only 1 trial demonstrating a clear clinically relevant difference from placebo. One trial in TTM found no difference between the NAC and placebo. Adverse effects were mild and included nausea, blurred vision, fatigue, tremor, and sweats. N-acetylcysteine titrated to 2400 or 2700 mg/day in divided doses was the most studied regimen.Relevance to Patient Care and Clinical Practice:Many OCDRD patients fail to completely respond to first-line treatment with cognitive behavioral therapy (CBT) and/or selective serotonin reuptake inhibitors (SSRIs) leaving practitioners with few additional treatment options. Preliminary efficacy and safety data are presented in this review.Conclusions:Limited evidence suggests children and adolescents with OCD refractory to SSRIs or CBT may benefit from NAC augmentation.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-17T04:55:42Z
      DOI: 10.1177/10600280221138092
       
  • Author’s Reply “Considerations Regarding a Cohort Study on Concomitant
           

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      Authors: Akhil Sood, Yong-Fang Kuo, Gulshan Sharma, Mukaila A. Raji
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-14T10:40:48Z
      DOI: 10.1177/10600280221136243
       
  • Comment: “Co-Prescribing of Central Nervous System-Active Medications
           

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      Authors: Sloan Smith, Sarah Beth Tucker, Ismaeel Yunusa
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-14T10:39:59Z
      DOI: 10.1177/10600280221136254
       
  • Proportion of Patients on Warfarin Therapy Who Are Eligible for Conversion
           to a Direct Oral Anticoagulant in the Setting of COVID-19

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      Authors: Rachel Hess, Elizabeth Renner, Erin Mouland, Denise Sutter-Long, Nghi Ha
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Warfarin, a commonly prescribed anticoagulant, requires frequent lab monitoring. Lab monitoring puts patients at risk of COVID-19 exposure and diverts medical resources away from health care systems. Direct oral anticoagulants (DOACs) do not require routine therapeutic monitoring and are indicated first line for nonvalvular atrial fibrillation (NVAF) stroke prevention and venous thromboembolism (VTE) prevention/treatment.Objective:The purpose of the study was to determine the proportion of patients who qualify for DOACs and assess for predictors of qualification.Methods:This cross-sectional study investigated patients on warfarin managed by Michigan Medicine Anticoagulation Service. Direct oral anticoagulant eligibility criteria were established using apixaban, dabigatran, and rivaroxaban package inserts. Patient eligibility was determined through chart review. The primary outcome was the proportion of patients who qualify for DOACs based on clinical factors. Predictors of DOAC qualification were assessed.Results:This study included 3205 patients and found 51.8% (n = 1661) of patients qualified for DOACs. Qualifying patients were older (71.9 vs 59.4 years, P < 0.0001) with a higher CHA2DS2 VASc (3.7 vs 3.4, P < 0.0007). The primary disqualifying factor was extreme weight, high and low. Accounting for a patient’s sex and referral source, age> 65 (odds ratio [OR] = 1.9, P < 0.0001) and NVAF indication (OR = 5.6, P < 0.0001) were significant predictors for DOAC qualification.Conclusion and Relevance:Approximately 52% of patients on warfarin were eligible for DOACs. This presents an opportunity to reduce patient exposure to health care settings and health care utilization in the setting of COVID-19. Increased costs of DOACs need to be assessed.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-14T08:41:27Z
      DOI: 10.1177/10600280221136874
       
  • A Systematic Review of Antimicrobial Stewardship Interventions to Improve
           Management of Bacteriuria in Hospitalized Adults

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      Authors: Mari Humphrey, Gemma MacDonald, Heather Neville, Melissa Helwig, Tasha Ramsey, Holly MacKinnon, Ingrid Sketris, Lynn Johnston, Emily K. Black
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To determine whether implementation of antimicrobial stewardship (AMS) interventions improve management of bacteriuria in hospitalized adults.Data Sources:EMBASE, MEDLINE, CINAHL, and Clinical Trials Registries via Cochrane CENTRAL were searched from inception through May 2021. Reference lists of included studies were searched, and Scopus was used to retrieve articles that cited included references.Study Selection and Data Extraction:Randomized and nonrandomized trials, controlled before-after studies, interrupted time-series studies, and repeated measures studies evaluating AMS interventions for hospitalized adult inpatients with bacteriuria were included. Risk of bias was assessed independently by 3 team members and compared. Results were summarized descriptively.Data Synthesis:The search yielded 5509 articles, of which 13 met inclusion criteria. Most common interventions included education (N = 8) and audit and feedback (N = 5) alone or in combination with other interventions. Where assessed, resource and antimicrobial use primarily decreased and appropriateness of antimicrobial use improved; however, impact on guideline adherence was variable. All studies were rated as having unclear or serious risk of bias. This review summarizes and assesses the quality of evidence for AMS interventions to improve the management of bacteriuria. Results provide guidance to both AMS teams and researchers aiming to develop and/or evaluate AMS interventions for management of bacteriuria.Conclusions:This review demonstrated benefit of AMS interventions on management of bacteriuria. However, most studies had some risk of bias, and an overall effect across studies is unclear due to heterogeneity in outcome measures.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-11T10:00:12Z
      DOI: 10.1177/10600280221134539
       
  • Clinical Outcomes of Oral Zinc Therapy in Hepatic Encephalopathy Treatment

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      Authors: Megan Kunka Fritz, Anthony A. Mangino, Taylor V. Hunt, C. Tyler Pitcock, Adam J. Dugan, Kishore Karri, Pradeep Yarra
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Additional therapies for hepatic encephalopathy (HE) treatment are warranted. There are data evaluating the use of zinc for HE; however, clinical outcomes, specifically in the United States, are unknown.Objective:To compare 30-day and 1-year all-cause readmission rates in patients with cirrhosis complicated by HE on lactulose and rifaximin to those on lactulose, rifaximin, and zinc.Methods:This retrospective study included patients admitted with documented cirrhosis and home medications of lactulose and rifaximin, with or without zinc. Patients were stratified into 2 groups: those receiving lactulose and rifaximin for HE (control) and those receiving lactulose, rifaximin, and zinc for HE (treatment). The primary outcomes were 30-day and 1-year all-cause readmission rates.Results:One-hundred fifty-seven patients were included (102 in control group, 55 in treatment group). Regarding 30-day and 1-year all-cause readmission rates, there was no difference between the control and treatment groups.Conclusion and Relevance:This is the first study conducted in the United States evaluating zinc for HE treatment. Zinc did not impact 30-day or 1-year all-cause readmission rates. Further studies are warranted to evaluate the potential benefit of zinc for HE, possibly in correlation with Model for End-stage Liver Disease-Sodium (MELD-Na) scores.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-11T09:57:12Z
      DOI: 10.1177/10600280221134283
       
  • Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the
           Literature and Implications for Clinical Practice

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      Authors: Courtney L. Bradley, Sara M. McMillin, Andrew Y. Hwang, Christina H. Sherrill
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:The objective of this article was to review pharmacology, efficacy, safety, and place in therapy of tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.Data Sources:PubMed/MEDLINE and ClinicalTrials.gov were searched through September 7, 2022, using the keyword “tirzepatide.”Study Selection and Data Extraction:Clinical trials with available results were included.Data Synthesis:Seven published phase 3, multicenter, randomized, parallel-group trials investigated efficacy and safety of tirzepatide versus placebo, semaglutide, insulin degludec, and insulin glargine for type 2 diabetes mellitus (T2DM) treatment. Studies included adults with uncontrolled T2DM and body mass index above 23 or 25 kg/m2. Hemoglobin A1c reduction from baseline was greater with tirzepatide across all studies with absolute reductions up to 3.02% and relative reductions ranging 0.44% (vs semaglutide) to 2.11% (vs placebo). Weight loss was significant. Incidence of gastrointestinal adverse effects (AE) was similar to semaglutide, and major cardiovascular events was similar to insulin glargine.Relevance to Patient Care and Clinical Practice:Studies demonstrated greater A1c lowering and weight reduction versus placebo and active comparators with AE similar to semaglutide, suggesting tirzepatide will be a valuable addition to the growing list of antidiabetic medications. Although tirzepatide’s effects on major cardiovascular events was not increased when compared with insulin glargine, further evidence is needed to assess long-term implications on cardiovascular outcomes compared with agents with proven cardiovascular benefits.Conclusions:Tirzepatide has the potential to significantly impact the clinical management of T2DM, and results of ongoing clinical trials will help to fully determine its place in therapy.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-11T09:53:12Z
      DOI: 10.1177/10600280221134127
       
  • A Review of Current and Emerging Therapeutic Options for Hemophagocytic
           Lymphohistiocytosis

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      Authors: Jenna Summerlin, Drew A. Wells, Mary Kate Anderson, Zachery Halford
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To provide an overview of clinical sequelae and emerging treatment options for hemophagocytic lymphohistiocytosis (HLH).Data Sources:A literature search was conducted using the search terms “hemophagocytic lymphohistiocytosis,” “hemophagocytic syndrome,” “macrophage activation syndrome,” and “treatment” on Ovid and PubMed from January 1, 2017, through September 28, 2022.Study Selection and Data Extraction:Relevant clinical trials, meta-analyses, case reports, review articles, package inserts, and guidelines to identify current and emerging therapeutic options for the management of HLH.Data Synthesis:Genetic disorders and secondary causes may trigger HLH in both children and adults. Notable improvements in the diagnosis of HLH were seen with implementation of the HLH-2004 standard diagnostic criteria; however, timely and accurate identification of HLH remain significant barriers to optimal management. Multiagent immunochemotherapy are the backbone of aggressive therapy for acutely ill patients with HLH.Relevance to Patient Care and Clinical Practice:The global coronavirus 2019 (COVID-19) pandemic and emerging immune effector cell therapies have served to highlight the concerns with immune dysregulation and subsequent HLH precipitation. Without prompt identification and treatment, HLH can be fatal. Historically, the clinician’s armamentarium for managing HLH was sparse, with etoposide-based protocols serving as the standard of care. Relapsed or refractory disease portends a poor prognosis and requires additional treatment options. Second- or subsequent-line options now include hematopoietic stem cell transplantation, emapalumab, alemtuzumab, anakinra, ruxolitinib, and tocilizumab.Conclusions:Improvements in diagnostic methods and novel immunosuppressive treatment strategies, including noncytotoxic immunochemotherapy, have transformed the therapeutic landscape. Unfortunately, many unanswered questions remain. Additional studies are required to optimize dosing, schedules, treatment sequences, and indications for novel treatment options.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-09T10:59:10Z
      DOI: 10.1177/10600280221134719
       
  • Assessing Neonatal Opioid Withdrawal Syndrome Severity as a Function of
           Maternal Buprenorphine Dose and Umbilical Cord Tissue Concentrations

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      Authors: Divya Rana, Allison R. McLeod, Piyamas K. Gaston, David M. Hill, Massroor Pourcyrous
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Infants born to mothers with opioid use disorder (OUD) and prenatally treated with buprenorphine have a significantly lower incidence of neonatal opioid withdrawal syndrome (NOWS), its treatment duration, and hospital length of stay compared with methadone. However, risk of NOWS remains and clinicians continue to lack an objective methodology to predict NOWS severity among these infants.Objective:The purpose of this study was to assess the relationship between buprenorphine exposure, umbilical cord tissue (UCT) concentrations, and NOWS development and severity.Methods:A single-center retrospective observational cohort study from March 2018 through June 2020 of newborns exposed to buprenorphine in utero. Associations between quantified buprenorphine exposure, neonatal UCT concentrations, NOWS diagnosis, and severity were made using regression analyses.Results:A total of 24 mothers and 25 neonates were included. Length of maternal buprenorphine therapy (months) positively correlated to norbuprenorphine (r2 = 0.234, P = 0.019) and buprenorphine + norbuprenorphine UCT concentrations (r2 = 0.203, P = 0.031). A positive relationship was seen between active metabolite concentrations and cumulative morphine dose (mg/kg) for treatment of severe NOWS (r2 = 0.471, P = 0.007). A 0.36 ng/g buprenorphine + norbuprenorphine UCT (CI = 0.002-0.72, P = 0.049) equated in a 1-point increase in modified peak Finnegan score.Conclusion and Relevance:Buprenorphine and norbuprenorphine UCT concentrations can allow for quantification of in utero fetal exposure and demonstrate an association with a longer duration of exposure with the severity and treatment of NOWS in exposed infants.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-11-02T09:30:58Z
      DOI: 10.1177/10600280221134643
       
  • Risk Factors for Prolonged Opioid Use Following Total Hip Arthroplasty and
           Total Knee Arthroplasty: A Narrative Review of Recent Literature

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      Authors: Carter VanIderstine, Emily Johnston
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To provide pharmacists and other health care professionals with the knowledge required to minimize the risk of prolonged opioid use following total hip arthroplasty (THA) and total knee arthroplasty (TKA).Data Sources:A literature search of PubMed and Embase was performed, and included the search terms: (opioid OR opiate OR opium) AND (risk factor OR predict*) AND (arthroplasty OR replacement) NOT shoulder.Study Selection and Data Extraction:Randomized control trials, cohort studies (both prospective and retrospective), systematic reviews, and meta-analyses were included if risk ratios (RRs) or odds ratios (ORs) were reported and published within the last 5 years.Data Synthesis:]Twenty studies met inclusion criteria, including 2 meta-analyses and 2 prospective studies. There were several risk factors that overlapped between studies and presented clinically significant risks for prolonged opioid use following THA and TKA surgery. Of these, age < 65 (RRs: 1.15-9.36), preoperative opioid use (RRs: 1.09-7.81), larger quantities of opioids prescribed at discharge (RRs: 1.26-8.81), and TKA surgery (RRs: 1.73-6.07) were the most significant. Several risk factors were recently described, including migraines (RRs: 1.14-5.11) and fibromyalgia (RRs: 1.1-2.3) that may be of interest for further research.Relevance to Patient Care and Clinical Practice:This review presents a discussion of the factors associated with prolonged opioid use following THA and TKA surgeries, which are among the most common orthopedic surgeries.Conclusions:Prescribers should carefully consider patient-specific factors when prescribing opioids as there are several factors, including age, surgery type, and medical conditions that can predispose patients to prolonged opioid use.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-31T09:08:16Z
      DOI: 10.1177/10600280221133078
       
  • Evaluation of Bleeding in Orthopedic Surgery With Perioperative Use of
           Serotonergic Antidepressants

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      Authors: Soon H. Yang, Charles F. Seifert
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:The use of serotonergic antidepressants (SADs) is associated with an increase in bleeding, and their exposure during the perioperative period increases the potential bleeding risk in patients undergoing surgical operations.Objective:The purpose of this study was to compare the rates of bleeding between patients on perioperative SADs and those not on SADs in patients undergoing orthopedic surgical procedures.Methods:A retrospective cohort study was conducted with patients who were admitted to a single tertiary care county teaching hospital for orthopedic surgery. Outcomes evaluated were requirements of ≥ 2 units of packed red blood cells (PRBCs) and length of hospital stay for those requiring ≥ 2 units of PRBCs.Results:Of 273 patients, a significantly higher percentage of patients who received SADs required ≥ 2 units of PRBCs (19.3% vs 6.9%; P = 0.0049). Patients who required transfusion had a higher median (interquartile range [IQR]) age (79 [64-84.6] vs 65 [59-75]; P < 0.0001). The risk of requiring ≥ 2 units of PRBCs transfusion was greater for individuals having an anemia comorbidity (odds ratio [OR], 4.55; 95% CI, 1.95-10.62, P = 0.0004). Patients who required ≥ 2 units of PRBCs had a longer median hospital stay than those who did not receive ≥ 2 units of PRBCs (8 [5-10.1] vs 4 [3-5]; P < 0.0001).Conclusion and Relevance:Receiving SADs in the perioperative period is associated with a higher transfusion requirement in patients undergoing orthopedic surgery. Clinicians should be aware of this increased risk for patients who are taking SADs while undergoing surgical procedures.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-29T09:40:11Z
      DOI: 10.1177/10600280221134108
       
  • Effect of Antidiabetic Therapy on Clinical Outcomes of COVID-19 Patients
           With Type 2 Diabetes: A Systematic Review and Meta-Analysis

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      Authors: Kegang Zhan, Liuqi Weng, Li Qi, Luhan Wang, Hao Lin, Xiaoyu Fang, Hong Jia, Xiangyu Ma
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:No study has yet systematically evaluated the effect of antidiabetic therapy on clinical outcomes of COVID-19 patients with type 2 diabetes (T2D).Objective:We aimed to evaluate the effect of different antidiabetic therapy on clinical outcomes of COVID-19 patients with T2D.Methods:We comprehensively retrieved the published research which examined the effect of antidiabetic therapy on clinical outcomes of COVID-19 patients with T2D. The odds ratio (OR) and its 95% confidence interval (95% CI) for clinical outcomes were calculated using the random-effects model, and meta-regression was adopted to evaluate the potential sources of heterogeneity between studies.Results:A total of 54 studies were included in this study. We found that the use of metformin (OR = 0.66, 95% CI: 0.58-0.75), SGLT-2i (OR = 0.80, 95% CI: 0.73-0.88), and GLP-1ra (OR = 0.83, 95% CI: 0.70-0.98) were significantly associated with lower mortality risk in COVID-19 patients with T2D, while insulin use might unexpectedly increase the ICU admission rate (OR = 2.32, 95% CI: 1.34-4.01) and risk of death (OR = 1.52, 95% CI: 1.32-1.75). No statistically significant associations were identified for DPP-4i, SUs, AGIs, and TZDs.Conclusion and Relevance:We demonstrated that the usage of metformin, SGLT-2i, and GLP-1ra could significantly decrease mortality in COVID-19 patients with T2D. The heterogeneity across the studies, baseline characteristics of the included patients, shortage of dosage and the duration of antidiabetic drugs and autonomy of drug selection might limit the objectivity and accuracy of results. Further adequately powered and high-quality randomized controlled trials are warranted for conclusive findings.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-29T09:36:11Z
      DOI: 10.1177/10600280221133577
       
  • Baricitinib Versus Tocilizumab for the Treatment of Moderate to Severe
           COVID-19

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      Authors: Nancy Kierstin Reid, Kayla Rena Joyner, Temeka Dawn Lewis-Wolfson
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:To date, minimal data directly compare tocilizumab with baricitinib for treatment in moderate to severe COVID-19.Objective:To compare the rates of in-hospital mortality with progression to mechanical ventilation in patients with COVID-19 who received either tocilizumab or baricitinib.Methods:The authors conducted a single-centered, institutional review board–approved, retrospective cohort study. Patients who were 18 years or older who were hospitalized with COVID-19 and who received tocilizumab or baricitinib were included. The primary end point is a composite outcome of progression to mechanical ventilation or in-hospital mortality. Secondary end points include components of the composite outcome and progression to higher level of care, duration of mechanical ventilation, and hospital and intensive care length of stay. Safety end points include the incidence of infections and thrombosis.Results:A total of 176 patients were included, of whom 61 (34.7%) received tocilizumab and 115 (65.3%) received baricitinib. In the primary outcome, there was no difference between the groups (52.5% tocilizumab vs 44.3% baricitinib, P = 0.305). For safety outcomes, there was a higher instance of thrombosis (11.5% tocilizumab vs 3.5% baricitinib, P = 0.042) and rates of antibiotic use after initiation of therapy (55.7% tocilizumab vs 38.3% baricitinib, P = 0.026) in the tocilizumab group.Conclusion and Relevance:There was no significant difference in the composite outcome in patients who received tocilizumab or baricitinib for the treatment of COVID-19. However, there was an increase in rates of thrombosis in those receiving tocilizumab compared with baricitinib. These results need to be confirmed in larger prospective, randomized trials.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-29T09:31:51Z
      DOI: 10.1177/10600280221133376
       
  • Naloxone Versus Methylnaltrexone for Opioid-Induced Constipation in
           Critically Ill Patients

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      Authors: Ehsan A. Habeeb, Lena K. Tran, Melanie Z. Goodberlet, Kenneth E. Lupi, Jeremy R. DeGrado, Kevin M. Dube
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Opioid-induced constipation (OIC) may occur in up to 81% of critically ill patients and can lead to many complications. Opioid antagonists are a reasonable approach and may be used for managing OIC.Objective:The purpose of this study was to assess the efficacy of enteral naloxone (NLX) versus subcutaneous methylnaltrexone (MNTX) for the management of OIC in critically ill patients.Methods:A retrospective analysis was conducted on adult patients who received NLX or MNTX and a continuous opioid infusion for at least 48 hours. The primary end point was time to resolution of constipation, defined as hours to first bowel movement (BM) after the first dose of an opioid antagonist. Reversal of analgesia was assessed by comparing the total number of morphine milligram equivalents (MME) 24 hours preopioid and postopioid antagonist administration. Univariate and multivariate analyses were conducted to assess treatment response within 48 hours.Results:Baseline characteristics were similar between patients receiving NTX (n = 89) and MNTX (n = 71). However, the time to the first BM with NLX was 18 hours compared with 41 hours with MNTX (P = 0.004). There was no difference in MME requirements 24 hours pre/post NLX or MNTX administration. Naloxone administration was identified as a statistically significant predictor of BM within 48 hours (odds ratio [OR] = 2.68 [1.33-5.38]).Conclusion and Relevance:The time to first BM was shorter with enteral NLX. Both NLX and MNTX appear to be effective for the management of OIC without causing reversal of analgesia. Future controlled, prospective trials comparing these agents are warranted.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-29T09:28:45Z
      DOI: 10.1177/10600280221132851
       
  • Clinical Outcomes and Treatment Strategies in Patients With
           Non-Carbapenemase-producing Carbapenem-Resistant Versus
           Carbapenem-Susceptible Enterobacterales Infections

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      Authors: Ashita Debnath, Kelly E. Pillinger, Alysa J. Martin, David Dobrzynski, Andrew Cameron, Stephanie Shulder
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Carbapenem-resistant Enterobacterales (CRE) are difficult to treat and can cause significant morbidity and mortality, however most data reflect carbapenemase-producing infections.Objective:Our objective was to evaluate clinical outcomes of non-carbapenemase-producing CRE (nCP-CRE) compared with carbapenem-susceptible Enterobacterales (CSE) infections.Methods:This was a retrospective, multicenter, observational study (January 1, 2018 to December 31, 2020). The primary outcome was clinical success at 30 days with secondary outcomes, including clinical success at 90 days, clinical success based on treatment for nCP-CRE, persistent bacteremia, intensive care unit (ICU) admission, length of stay, and rate of Clostridioides difficile or multidrug resistant infections.Results:The final analysis included 211 patients: 142 (67%) with CSE and 69 (33%) with nCP-CRE infections. Prior carbapenem exposure was more common with nCP-CRE (15% vs 4%, P = 0.01). Clinical success at 30 days was similar between groups (77% vs 74%, P = 0.73). There were no differences in secondary outcomes. There was an overall low use of carbapenems (empiric 6%, definitive 7%). Most nCP-CRE infections were treated with a monotherapy carbapenem-sparing regimen (empiric 88%, definitive 90%). Limitations include the retrospective design and the high rate of urinary infections.Conclusion and Relevance:Our study found no difference in clinical outcomes between nCP-CRE and CSE infections. Application of this study with future studies would help in determining optimal regimens for these infections.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-21T11:44:57Z
      DOI: 10.1177/10600280221132019
       
  • Nivolumab/Relatlimab: A Novel Addition to Immune Checkpoint Inhibitor
           Therapy in Unresectable or Metastatic Melanoma

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      Authors: Allison L. Phillips, David J. Reeves
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:The aim of this article is to assess available data regarding use of nivolumab/relatlimab for adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.Data Sources:A search of PubMed conducted from August 2019 to August 2022 with the search terms Opdualag, nivolumab AND relatlimab, and BMS-986016 resulted in 14 publications.Study Selection and Data Extraction:Relevant clinical trials written in English language were analyzed.Data Synthesis:Nivolumab/relatlimab was approved by the Food and Drug Administration following results of a phase 1/2 trial and phase 2/3 RELATIVITY-047 trial. Nivolumab/relatlimab demonstrated a median progression free survival (PFS) of 10.1 months in the first-line setting without new safety signals. The PFS benefits appear greatest in those with programmed cell death-ligand 1 (PD-L1)
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-21T11:39:05Z
      DOI: 10.1177/10600280221131396
       
  • Adjunctive Dexmedetomidine in Alcohol Withdrawal Syndrome: A Systematic
           Review and Meta-analysis of Retrospective Cohort Studies and Randomized
           Controlled Trials

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      Authors: Edgar Theodore T. Polintan, Lester Mico L. Danganan, Nikki S. Cruz, Sharina C. Macapagal, Jesus Alfonso Catahay, Gabriel Patarroyo-Aponte, Zurab Azmaiparashvili, Kevin Bryan Lo
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To investigate whether dexmedetomidine (DEX), as adjunctive therapy to benzodiazepine (BZD), is superior to BZD alone in critically ill patients with alcohol withdrawal syndrome (AWS).Data Sources:PubMed Central, Cochrane CENTRAL, ClinicalTrials.gov and Google Scholar were used as search databases. Specific keywords and MeSH terms were “dexmedetomidine,” “benzodiazepine,” and “alcohol withdrawal syndrome.” The last search was on September 16, 2022.Study Selection and Data Extraction:Randomized controlled trials (RCTs) and nonrandomized/cohort studies exploring the use of DEX in the management of AWS were included. A total of 12 studies were included in the systematic review and 7 in the meta-analysis.Data Synthesis:The intensive care unit length of stay (ICU LOS) was found to have a mean difference (MD) of 48.06 [37.48, 58.64], P =
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-19T05:32:21Z
      DOI: 10.1177/10600280221130458
       
  • Dilemmas Related to Direct-Acting Oral Anticoagulant Administration in
           Patients With Extreme Obesity

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      Authors: Brian L. Erstad, Jeffrey F. Barletta
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:The objective of the study was to discuss the controversies surrounding the use and dosing of direct-acting oral anticoagulants (DOACs) in obese patients recognizing the limitations of the existing evidence base that preclude strong recommendations.Data Sources:A literature search of MEDLINE was performed (2020 to end August 2022) subsequent to recent guidelines using the following search terms: direct acting anticoagulants, obesity, rivaroxaban, apixaban, edoxaban, dabigatran, dabigatran etexilate, and clinical practice guidelines.Study Selection and Data Abstraction:English-language studies and those conducted in adults were selected.Data Synthesis:The available randomized studies evaluating DOACs had relatively small numbers of patients with more extreme forms of obesity (body mass index [BMI]> 40 kg/m2) and none of the larger studies had a specific focus on dosing DOACs in obese patients. Recent guidelines by the International Society on Thrombosis and Haemostasis (ISTH) have specific recommendations for dosing DOACs in obesity. There are pharmacokinetic/pharmacodynamic and observational studies published before and after the ISTH guidelines with a focus on DOAC dosing in obese patients that generally support the recommendations in the guidelines, but most involved small numbers of patients usually with BMIs 50 kg/m2.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-19T05:28:02Z
      DOI: 10.1177/10600280221130456
       
  • A Meta-Analysis on the Impact of Prenatal and Early Childhood
           Antimicrobial Use on Autism Spectrum Disorders

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      Authors: Li-guo Li, Hong-guang Fu, Yong-hong Zhao, Peng-ju Zhao, Qing-kai Meng, Rui-juan Zheng, En-yao Li
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To investigate the impact of prenatal and early childhood antimicrobial use on autism spectrum disorders (ASD).Data Sources:We searched PubMed and Embase databases for relevant studies from inception to August 2022.Study Selection and Data Extraction:Peer-reviewed, observational studies were all acceptable. Raw data were extracted into a predefined worksheet and quality analysis was performed using the Newcastle–Ottawa Scale.Data Synthesis:Nineteen studies were identified in the meta-analysis. Prenatal antimicrobial exposure was not associated with ASD (P = 0.06> 0.05), whereas early childhood antimicrobial exposure was associated with an increased odds ratio of ASD (OR = 1.17, 95% CI = [1.08-1.27], P value < 0.001). The sibling-matched analysis, with a very limited sample size, suggested that neither prenatal (P = 0.47> 0.05) nor early childhood (P = 0.13> 0.05) antimicrobial exposure was associated with ASD. Medical professionals may need to take the possible association into consideration when prescribing an antimicrobial in children.Conclusions:Early childhood antimicrobial exposure could increase the incidence of ASD. In future studies, it would be necessary to control for confounding factors, such as genetic factors, parenteral age at birth, or low birthweight, to further validate the association.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-18T08:19:00Z
      DOI: 10.1177/10600280221130280
       
  • A Narrative Review of the Impact of Extracorporeal Membrane Oxygenation on
           the Pharmacokinetics and Pharmacodynamics of Critical Care Therapies

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      Authors: Jaimini S. Patel, Kirstin Kooda, Lauren A. Igneri
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:Extracorporeal membrane oxygenation (ECMO) utilization is increasing on a global scale, and despite technological advances, minimal standardized approaches to pharmacotherapeutic management exist. This objective was to create a comprehensive review for medication dosing in ECMO based on the most current evidence.Data Sources:A literature search of PubMed was performed for all pertinent articles prior to 2022. The following search terms were utilized: ECMO, pharmacokinetics, pharmacodynamics, sedation, analgesia, antiepileptic, anticoagulation, antimicrobial, antifungal, nutrition. Retrospective cohort studies, case-control studies, case series, case reports, and ex vivo investigations were reviewed.Study Selection and Data Extraction:PubMed (1975 through July 2022) was the database used in the literature search. Non-English studies were excluded. Search terms included both drug class categories, specific drug names, ECMO, and pharmacokinetics.Data Synthesis:Medications with high protein binding (>70%) and high lipophilicity (logP> 2) are associated with circuit sequestration and the potential need for dose adjustment. Volume of distribution changes with ECMO may also impact dosing requirements of common critical care medications. Lighter sedation targets and analgosedation may help reduce sedative and analgesia requirements, whereas higher antiepileptic dosing is recommended. Vancomycin is minimally affected by the ECMO circuit and recommendations for dosing in critically ill adults are reasonable. Anticoagulation remains challenging as optimal aPTT goals have not been established.Relevance to Patient Care and Clinical Practice:This review describes the anticipated impacts of ECMO circuitry on sedatives, analgesics, anticoagulation, antiepileptics, antimicrobials, antifungals, and nutrition support and provides recommendations for drug therapy management.Conclusions:Medication pharmacokinetic/pharmacodynamic parameters should be considered when determining the potential impact of the ECMO circuit on attainment of therapeutic effect and target serum drug concentrations, and should guide therapy choices and/or dose adjustments when data are not available.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-15T09:19:33Z
      DOI: 10.1177/10600280221126438
       
  • The Risk of Major Bleeding With Apixaban Administration in Patients With
           Acute Kidney Injury

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      Authors: Gabrielle Givens, Daniel Neu, Jacob Marler
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Apixaban is eliminated by the kidneys and in acute kidney injury (AKI) there is potential for an increase in apixaban exposure and bleeding events. In one instance, data have shown higher than normal bleed risk in patients with AKI, unless calibrated anti-factor Xa monitoring is used, which is not widely available.Objective:To evaluate bleeding with apixaban administration to hospitalized patients with an AKI in an unmonitored real-world scenario.Methods:We conducted a retrospective study of patients admitted to a large urban academic teaching hospital from April 2015 to March 2022, who received apixaban for venous thromboembolism or nonvalvular atrial fibrillation (NVAF). The primary outcome evaluated major bleeding when apixaban was administered to patients with or without an AKI.Results:A total of 232 patients were evaluated (116 per group). Most patients (79.7%) were on apixaban for NVAF, 32.7% had chronic kidney disease, 58.2% were on a medication increasing bleed risk, and HAS-BLED score was a median of 2 in both groups. No differences were noted between groups for bleeding (AKI group 7.8% vs non-AKI 3.4%; P = 0.15), and on regression analysis, coadministration of a P2Y12 inhibitor was predictive of major bleeding (odds ratio = 5.9; 95% confidence interval = 1.4-23.6).Conclusion and Relevance:Although no differences between groups were noted, apixaban use in the AKI group resulted in a higher than normally reported incidence of apixaban-associated major bleeding, and concomitant antiplatelet use increased bleed risk as well. Cautious use of apixaban and further investigation with larger studies are warranted in this area.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-14T11:05:55Z
      DOI: 10.1177/10600280221129831
       
  • Direct Oral Anticoagulants Versus Warfarin for Venous Thromboembolism
           Prophylaxis in Patients With Nephrotic Syndrome: A Retrospective Cohort
           Study

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      Authors: Aminat Tijani, Eric M. Coons, Britta Mizuki, Miranda Dermady, Katerina Stanilova, Ashley L. Casey, Muhannad Alqudsi, Mariella Gastanaduy, Ardem Elmayan, Adi Bamnolker, Juan Carlos Q. Velez
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Evidence supporting venous thromboembolism (VTE) prophylaxis with direct oral anticoagulants (DOACs) in patients with nephrotic syndrome (NS) is limited to case reports.Objective:The purpose of this study was to compare bleeding and thromboembolic events in this population.Methods:A retrospective cohort study was conducted in adults with NS initiated on a DOAC or warfarin for VTE prophylaxis between January 2013 and July 2021 within the Ochsner Health System. Patients with study drug exposure within the preceding 7 days, acute VTE within the preceding 6 months, or ≤7 days of study drug exposure were excluded. The primary outcome was the composite rate of major bleeding and clinically relevant nonmajor bleeding. Secondary outcomes included time to major bleeding and rate of new thromboembolic events. This study was approved by the Ochsner Health System Institutional Review Board.Results:Twenty-five DOAC and 19 warfarin patients were included. The primary outcome occurred in 8% vs 26.3% (P = 0.21) of patients treated with a DOAC or warfarin, respectively, and was driven by major bleeding (4% vs 21%, P = 0.25). Other secondary outcomes were similar between cohorts. The study was limited by a small sample size.Conclusion and Relevance:Use of DOACs for VTE prophylaxis resulted in a nonstatistically significant, but clinically relevant lower rate of major bleeding compared to warfarin. This study provides comparative data showing safe and effective use of DOACs in patients with NS. Prospective, randomized studies are needed to confirm results.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-09T06:19:15Z
      DOI: 10.1177/10600280221129348
       
  • Risankizumab-rzaa: A New Therapeutic Option for the Treatment of
           Crohn’s Disease

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      Authors: David Choi, Hilary Sheridan, Shubha Bhat
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review the pharmacologic and clinical profile of risankizumab-rzaa in the treatment of Crohn’s disease (CD).Data Sources:A PubMed search was performed from inception to August 2022 using keywords risankizumab, risankizumab-rzaa, interleukin-23 inhibitor, and Crohn’s disease. Information was obtained from package inserts as well as published abstracts.Study Selection and Data Extraction:Phase 2 and 3 studies plus relevant literature on risankizumab-rzaa pharmacologic and clinical profile were reviewed.Data Synthesis:Risankizumab-rzaa approval was based on ADVANCE, MOTIVATE, and FORTIFY. In these 3 phase 3 studies involving patients with moderate to severe CD, risankizumab-rzaa, when compared with placebo, resulted in clinical remission and endoscopic response in a significantly higher proportion of patients in both the induction and maintenance phase. In addition, risankizumab-rzaa met the secondary endpoints of clinical response, endoscopic improvement, corticosteroid-free remission, and mucosal healing. Common adverse events noted include nasopharyngitis, arthralgia, headache, abdominal pain, and nausea.Relevance to Patient Care and Clinical Practice:Risankizumab-rzaa is the first selective IL-23 inhibitor approved for CD and provides an additional therapeutic option for patients, particularly those who have been previously treated with other advanced inflammatory bowel disease therapies. Additional studies are required to determine how to best position risankizumab-rzaa in both bio-naïve and bio-experienced patients with CD.Conclusions:Risankizumab-rzaa is the most recent therapeutic advance for CD. It has a selective mechanism of action with a similar safety profile comparable with other currently approved advanced therapies.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-08T10:27:59Z
      DOI: 10.1177/10600280221130450
       
  • Fatal COVID-19 Pneumonia in a Rheumatoid Arthritis Patient Receiving
           Long-Term Rituximab Therapy

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      Authors: Chrong-Reen Wang, Wei-Chieh Lin
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-08T10:22:20Z
      DOI: 10.1177/10600280221129823
       
  • The Potential Synergistic Risk of Albuterol and Vasoactives in Acute Lung
           Injury Trials

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      Authors: Sultan Almuntashiri, Aaron Chase, Andrea Sikora, Duo Zhang
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Critically ill patients are often prescribed both inhaled beta-agonists and intravenous vasoactive; however, the interaction of the additive beta-agonist effects of these 2 agents remains largely uncharacterized.Objective:The purpose of this study was to evaluate how concomitant use of albuterol and vasoactive or inotropes affected ventilator-free days (VFDs) by re-analyzing the data from the Albuterol to Treat Acute Lung Injury (ALTA) trial.Methods:In this study, subjects were grouped to albuterol-vasoactive (n = 84) versus (vs) placebo-vasoactive (n = 62). Ventilator-free days, intensive care unit (ICU)-free days, organ failure-free days, cardiovascular adverse events, and 90-day mortality were compared. The primary outcome was VFDs.Results:Patients in the albuterol-vasoactive group had significantly fewer VFDs than patients in the placebo-vasoactive group (11 vs 19, P = 0.05). Patients in the albuterol-vasoactive group also had significantly fewer ICU-free days (9.5 vs 18.5, P = .006). The 90-day mortality was similar between groups (36.9% vs 27.4%, P = .20). Similarly, no significant difference in cardiac adverse events between the groups (14.3% vs 11.3%, P = 0.59).Conclusion and Relevance:This study has shown fewer VFDs for patients who received both vasoactive and albuterol. There were also fewer ICU-free days when compared to those on vasoactive only. Given the common use of both agents, a prospective evaluation of the additive adverse effects of beta-agonism is warranted.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-03T04:59:35Z
      DOI: 10.1177/10600280221128014
       
  • Does a Positive Methicillin-Resistant Staphylococcus aureus (MRSA) Nasal
           Screen Predict the Risk for MRSA Skin and Soft Tissue Infection'

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      Authors: Allison M. Hitchcock, Robert W. Seabury, Wesley D. Kufel, Sara Farooqi, Jeffrey M. Steele, William Darko, Christopher D. Miller, Elizabeth A. Feldman
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Skin and soft tissue infections (SSTIs) are often caused by gram-positive bacteria that colonize the skin. Given the overuse of antibiotics, SSTIs are increasingly caused by resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Guidance on the utility of MRSA nasal screening for MRSA SSTI is limited.Objective:To determine whether MRSA nasal screening predicts the risk of MRSA SSTIs.Methods:This was a single-center, retrospective cohort study of adult patients with an SSTI diagnosis that had MRSA nasal screening and wound cultures obtained within 48 hours of starting antibiotics. Sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ratios were calculated using VassarStats. Pretest and posttest probabilities were estimated with Microsoft Excel.Results:A total of 884 patient encounters were reviewed between December 1, 2018, and October 31, 2021, and 300 patient encounters were included. The prevalence of MRSA SSTI was 18.3%. The MRSA nasal colonization had a sensitivity of 63.6%, specificity of 93.9%, positive predictive value of 70.0% (95% CI = 55.2%-81.7%), negative predictive value of 92.0% (95% CI = 87.7%-94.9%), positive likelihood ratio of 10.39 (95% CI = 6.12-17.65), negative likelihood ratio of 0.39 (95% CI = 0.27-0.55), positive posttest probability of 70.0%, and negative posttest probability of 8.0%.Conclusions:Given the high positive likelihood ratio, a positive MRSA nasal screen was associated with a large increase in the probability of MRSA SSTI at our institution, and a negative MRSA nasal screen was associated with a small but potentially significant decrease in the probability of MRSA SSTI.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-03T04:53:31Z
      DOI: 10.1177/10600280221127389
       
  • Why Do the Mechanistic Actions of Albumin Not Translate Into Tangible
           Clinical Benefits'

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      Authors: Brian L. Erstad
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Albumin has only reduced crude mortality in one randomized controlled trial conducted to date. This raises the question as to why potentially beneficial oncotic and pleiotropic properties of albumin do not consistently translate into clinically important outcomes. Four postulated explanations are provided as to why the theoretical advantages of albumin are not apparent in clinical trials: diminished oncotic action due to leakage of albumin from the intravascular compartment, modification of the pleiotropic properties of albumin both in vitro and in vivo, the ability of other plasma proteins to take over the major functions of albumin, and possible adverse effects.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-10-03T04:45:50Z
      DOI: 10.1177/10600280221126629
       
  • Association of Statin Adherence With the Development of Nonalcoholic Fatty
           Liver Disease: A Nested Case-Control Study Using a Japanese Claims
           Database

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      Authors: Chihiro Nakagawa, Satoshi Yokoyama, Kouichi Hosomi
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Statins are expected to have beneficial effects on nonalcoholic fatty liver disease (NAFLD); however, evidence remains insufficient.Objective:In this study, we aim to investigate the association between statin adherence and NAFLD development.Methods:We conducted a nested case-control study of statin users using the Japan Medical Data Center administrative claims database (January 2005 to January 2020). Individuals who developed NAFLD were designated as cases. For each case, we randomly selected a maximum of 10 controls using risk set sampling. Good adherence was defined as the proportion of days covered (PDC) of ≥0.80. Higher intensity was defined as the median or higher of a cumulative defined daily dose (cDDD) per day covered by statin prescription. Conditional logistic regression analysis was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs).Results:In this study, 253 383 patients with the first statin prescription were identified. Of them, 7080 were selected and matched to 70 734 controls. The medians of PDC and intensity were 0.88 (interquartile range [IQR], 0.61-0.96) and 0.32 (IQR, 0.25-0.50) cDDD/day, respectively. Good adherence was significantly associated with a reduced risk of NAFLD development (adjusted OR, 0.82; 95% CI, 0.78-0.86). Higher intensity was not significantly associated with a reduced risk of NAFLD development (adjusted OR, 1.02; 95% CI, 0.97-1.08).Conclusion and Relevance:Good adherence to statins is associated with a reduced risk of NAFLD development, regardless of the statin intensity. Appropriate statin therapy could reduce the risk of NAFLD development.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-28T06:11:08Z
      DOI: 10.1177/10600280221126971
       
  • Impact of Piperacillin-Tazobactam Dosing in Septic Shock Patients Using
           Real-World Evidence: An Observational, Retrospective Cohort Study

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      Authors: John M. Allen, Devi Surajbali, Dalena Q. Nguyen, Jolanta Kuczek, Maithi Tran, Brianna Hachey, Carinda Feild, Bethany R. Shoulders, Steven M. Smith, Stacy A. Voils
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Sepsis and septic shock are associated with significant morbidity and mortality. Rapid initiation of appropriate antibiotic therapy is essential, as inadequate therapy early during septic shock has been shown to increase the risk of mortality. However, despite the importance of appropriate antibiotic initiation, in clinical practice, concerns for renal dysfunction frequently lead to antibiotic dose reduction, with scant evidence on the impact of this practice in septic shock patients.Objective:The purpose if this article is to investigate the rate and impact of piperacillin-tazobactam dose adjustment in early phase septic shock patients using real-world electronic health record (EHR) data.Methods:A multicenter, observational, retrospective cohort study was conducted of septic shock patients who received at least 48 hours of piperacillin-tazobactam therapy and concomitant receipt of norepinephrine. Subjects were stratified into 2 groups according to their cumulative 48-hour piperacillin-tazobactam dose: low piperacillin-tazobactam dosing (LOW;
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-26T06:18:43Z
      DOI: 10.1177/10600280221125919
       
  • Should We Account Valproate Therapeutic Failure Only to Drug Potency If We
           Still Cannot Measure Liquid Medications Properly'

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      Authors: Jaqueline Kalleian Eserian, José Carlos Fernandes Galduróz
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-20T05:34:22Z
      DOI: 10.1177/10600280221125166
       
  • Intranasal Olopatadi: Mometasone in the Treatment of Seasonal Allergic
           Rhinitis

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      Authors: Lauren Lim, Melissa Lipari, Pramodini Kale-Pradhan
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review the pharmacology, efficacy, and safety of intranasal olopatadine hydrochloride-mometasone furoate (OM) combination in the treatment of seasonal allergic rhinitis (SAR).Data sources:The PubMed database and ClinicalTrials.gov were searched using the following terms: mometasone + olopatadine, GSP301, mometasone furoate, and olopatadine hydrochloride.Study Selection and Data Extraction:Articles published in English between January 1987 and August 2022 related to pharmacology, safety, and clinical trials were assessed.Data Synthesis:In 2 phase II clinical trials, twice-daily (BID) and once-daily (QDay) intranasal OM demonstrated significant improvements in reflective total nasal symptom score (rTNSS) (BID P < 0.001 and QDay P < 0.001) and instantaneous total nasal symptom score (iTNSS) (BID P < 0.001 and P < 0.0001; QDay P < 0.001 and P < 0.0001). In 2 phase III clinical trials, BID OM showed significant improvements in rTNSS vs. placebo (P < 0.001), olopatadine monotherapy (P = 0.03 and P = 0.003), and mometasone monotherapy (P = 0.02 and P = 0.059).Relevance to Patient Care and Clinical Practice:OM is indicated for treatment of SAR symptoms. Caution with use must be considered for certain high-risk patients, existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Due to its quick and sustained onset of action, OM may be an ideal agent for initial treatment of moderate-severe SAR for patients 12 years and older.Conclusion:OM significantly improves SAR symptoms and is a viable treatment option in short-term SAR.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-20T05:24:02Z
      DOI: 10.1177/10600280221124230
       
  • Comment: Comparison of Early Versus Late Initiation of Hydrocortisone in
           Patients With Septic Shock in the ICU Setting

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      Authors: Oula Samaan, Dana Bojorquez, Gregory B. Tallman
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-17T06:45:25Z
      DOI: 10.1177/10600280221124510
       
  • Optimal Injectable Haloperidol Dose Assessment in the Older Hospitalized
           Inpatient

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      Authors: Jaylan M. Yuksel, Jay M. Brenner, Sarah Britton, Harneet Bhatti, John Noviasky
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Haloperidol can be used off-label for agitation and/or delirium in older individuals. The recommended initial intramuscular or intravenous dose is 0.5 to 1 mg. However, the evidence to support these doses is nominal.Objectives:The primary outcome was to determine whether low-dose injectable haloperidol (≤0.5 mg) was similar in effect to higher doses by assessing the need for repeat doses within 4 hours as a surrogate marker. Secondary outcomes include comparison of length of stay, utilization of restraints, and discharge outcomes between dosage groups.Methods:This was a retrospective, single-center, cohort study. Patients aged ≥65 years who received haloperidol injectable who were not on antipsychotics prior to admission were reviewed.Results:In the low-dose group (n = 15), no patients required additional haloperidol doses within 4 hours compared with 1 patient each in the medium-dose (n = 23) and high-dose (n = 19) groups (P = 0.94). There was a difference regarding length of stay, utilization of restraints, and discharge to facility when admitted from home favoring low-dose haloperidol.Conclusions and Relevance:While limited by sample size and retrospective design, patients who received low-dose haloperidol demonstrated similar efficacy to those who received higher doses of haloperidol. In addition, secondary outcomes mentioned above favored the use of low-dose haloperidol as well. Based on these findings, low-dose haloperidol is a reasonable initial dose for the agitated older patient.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-13T09:27:47Z
      DOI: 10.1177/10600280221124615
       
  • Analysis of Bicarbonate-Based Purge Solution in Patients With Cardiogenic
           Shock Supported Via Impella Ventricular Assist Device

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      Authors: Kyle Bergen, Shashank Sridhara, Nicholas Cavarocchi, Scott Silvestry, Davide Ventura
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:The Impella device is a continuous axial flow pump which provides hemodynamic support by expelling blood into the aorta. The manufacturer recommends using dextrose-based heparin containing solutions as the default purge. As an alternative to anticoagulant solutions, a bicarbonate-based purge solution has been proposed with limited data substantiating adequate protection and durability.Objective:To assess the impact of a bicarbonate-based purge solution on Impella pump thrombosis and bleeding outcomes.Methods:Single-center, retrospective study of cardiogenic shock patients who received an Impella between December 2020 through September 2021. Patients were evaluated based on whether they received bicarbonate-based purge solutions or remained on heparin-based purge solutions. The primary outcome was the rate of Impella pump thrombosis, defined as multiple purge pressures greater than 800 mm Hg. Secondary outcomes included incidence of bleeding defined as a drop in Hgb of at least 2 g/dL along with use of blood products and supratherapeutic anticoagulation defined as an aPTT of greater than 70 seconds.Results:Forty-three patients received bicarbonate-based purge solutions and 49 controls received heparin. The incidence of purge thrombosis by purge pressure threshold was similar between the two groups (16.3% vs 12.2%, P = 0.58). The rate of bleeding was lower with bicarbonate-based purge (27.9% vs 65.3%, P < 0.05) driven by a drop in Hgb of more than 2 g/dL. The rate of supratherapeutic anticoagulation was higher in the heparin arm (65.3% vs 27.9%, P < 0.05)Conclusion and Relevance:Nonanticoagulant purge alternatives offer the potential to reduce bleeding complications and laboratory monitoring burden while maintaining durability.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-13T09:24:38Z
      DOI: 10.1177/10600280221124156
       
  • Challenges With Using a Weight-Based Approach to Bolus Fluid Dosing in
           Obese Critically Ill Patients

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      Authors: Brian L. Erstad, Jeffrey F. Barletta
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      At least 30 mL/kg of crystalloid fluid administration within the first 3 hours of resuscitation is suggested by the current Surviving Sepsis Campaign guidelines for management of sepsis and septic shock. This commentary discusses the challenges with using a weight-based approach to bolus fluid dosing during the early phase of resuscitation of adult, obese patients. Based on the available literature, arguments can be made for the use of either ideal or adjusted body weight for weight-based fluid dosing, but there are concerns with fluid overload if using actual body weight to dose patients with more severe forms of obesity.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-10T05:23:14Z
      DOI: 10.1177/10600280221125169
       
  • Considerations for the Role of the Pharmacist in Managing Patients on
           Eculizumab for Hematopoietic Stem Cell Transplantation–Related
           Thrombotic Microangiopathy

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      Authors: Ariel Denson, Margaret Croom Taylor, Justin Arnall
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-05T08:58:46Z
      DOI: 10.1177/10600280221123089
       
  • Aminoglycoside Pharmacokinetics in Critically Ill Patients Undergoing
           Continuous Renal Replacement Therapy

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      Authors: Chelsea K. Krueger, Jeffrey J. Bruno, Frank P. Tverdek, Mike Hernandez, Ala Abudayyeh
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:There are few studies describing aminoglycoside pharmacokinetics during continuous renal replacement therapy (CRRT).Objective:To characterize the effect of CRRT on aminoglycoside clearance and volume of distribution (Vd).Methods:Retrospective observational pharmacokinetic study of adult critically ill oncologic patients who received a first dose of amikacin or tobramycin during CRRT between February 2012 and May 2017. Study outcomes included aminoglycoside clearance, Vd, and attainment of the target peak: MIC (minimum inhibitory concentration) ratio as a surrogate for dosing appropriateness.Results:In total, 80 patients were included, sustained low-efficiency dialysis (SLED), n = 49; continuous venovenous hemodialysis (CVVHD), n = 19; continuous venovenous hemofiltration (CVVH), n = 12. Fifty-one patients received amikacin at a median dose of 14.5 mg/kg per actual body weight and achieved a median peak level of 26.7 mg/L. Twenty-nine patients received tobramycin at a median dose of 6.5 mg/kg actual body weight and achieved a median peak level of 10.3 mg/L. The median aminoglycoside clearance was 63.1 mL/min and was similar between CRRT modality groups (P = 0.97). The median Vd was 0.47 L/kg and was different between the SLED and CVVH groups (P = 0.007). Attainment of target peak: MIC occurred in 29% in the total study population and 44% in the subgroup of 23 patients with isolates tested for aminoglycoside susceptibility.Conclusion and Relevance:Critically ill oncology patients undergoing CRRT exhibited reduced clearance and expanded Vd that was not significantly different between CRRT modalities. Current dosing regimens led to low peak concentrations and poor attainment of pharmacokinetic targets.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-05T05:44:48Z
      DOI: 10.1177/10600280221120600
       
  • Impact of a Multicomponent Educational Intervention on Community
           Pharmacy–Based Naloxone Services Implementation: A Pragmatic Randomized
           Controlled Trial

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      Authors: Lindsey A. Hohmann, Brent I. Fox, Kimberly B. Garza, Chih-Hsuan Wang, Christopher Correia, Geoffrey M. Curran, Salisa C. Westrick
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Despite US naloxone access laws, community pharmacists lack training and confidence in providing naloxone.Objective:To assess the impact of the Empowering Community Pharmacists program on pharmacists’ knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as naloxone prescriptions dispensed.Methods:A 3-month pragmatic randomized controlled trial was conducted from December 2018 to March 2019. Alabama community pharmacists were recruited by mail, email, phone, and fax and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly reminders only). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3), including naloxone knowledge (%correct); perceived barriers, attitudes, confidence, and intention regarding naloxone services implementation (7-point Likert-type scale; 1 = strongly disagree, 7 = strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention from T1 to T3 were assessed using 2-way mixed analysis of variance and adjusted analyses were conducted using generalized estimating equations with negative binomial distribution to assess associations between variables.Results:Of 55 participants (n = 27 intervention, n = 28 control), most were female (80.3%), white (80.6%), in independently owned pharmacies (39.1%). Increases in mean [SD] confidence (5.52 [1.03]-6.16 [0.74], P < 0.0005) and intention (5.35 [1.51]-6.10 [0.96], P = 0.023) occurred from pre- to post-program within the intervention group and were statistically significant compared with control (confidence P = 0.016, intention P = 0.014). Confidence (exp(β) = 1.46, P = 0.031) and perceived barriers (exp(β) = 0.75, P = 0.022) were associated with number of naloxone prescriptions dispensed.Conclusion and Relevance:The Empowering Community Pharmacists program improved community pharmacists’ confidence and intention regarding naloxone services implementation. Other states can adapt program elements according to their laws.ClinicalTrials.gov Identifier:NCT05093309
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-09-01T08:45:18Z
      DOI: 10.1177/10600280221120405
       
  • Pharmacist-Driven Methicillin-Resistant S. aureus Polymerase Chain
           Reaction Testing for Pneumonia

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      Authors: Victoria Marinucci, Patricia R. Louzon, Amy L. Carr, Jillian Hayes, Arnaldo Lopez-Ruiz, Jason Sniffen
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) can be detected using nasal swab polymerase chain reaction (PCR) assay and is associated with clinical MRSA infection. The MRSA nasal PCR has a rapid turnaround time and a negative predictive value for MRSA pneumonia of>98%; however, data are limited in critically ill patients.Objective:The purpose of this study is to determine the impact of a pharmacist-driven algorithm, utilizing MRSA PCR nasal screening on duration of anti-MRSA therapy in patients admitted to the intensive care unit (ICU) with suspected pneumonia.Methods:A single-center pre/post study was conducted in 4 ICUs at a large tertiary care community hospital. Adult patients admitted to the ICU initiated on vancomycin or linezolid for pneumonia managed using a pharmacist-driven MRSA PCR algorithm were included in the algorithm cohort. A historical cohort with standard management was matched 1:1 by age, type of pneumonia, and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The primary outcome was duration of anti-MRSA therapy. Secondary outcomes included MRSA rates, number of vancomycin levels, new onset of acute kidney injury (AKI), ICU length of stay (LOS), hospital LOS, and mortality.Results:Of the 245 patients screened, 50 patients met inclusion criteria for the algorithm cohort and were matched to 50 patients in the historical cohort. The duration of anti-MRSA therapy was significantly lower compared with the historical cohort (47 vs 95 hours; P < 0.001). Secondary outcomes were similar between groups for MRSA rates, new onset of AKI, LOS, and mortality. There were less vancomycin levels ordered in the algorithm cohort (2 vs 3, P = 0.026).Conclusions:A pharmacist-driven MRSA PCR algorithm significantly reduced anti-MRSA duration of therapy in critically ill patients with pneumonia. Future studies should validate these results in critically ill populations and in settings where MRSA pneumonia is more prevalent.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-30T06:44:02Z
      DOI: 10.1177/10600280221121144
       
  • Effectiveness, Safety, and Predictors of Response to 5%
           Lidocaine-Medicated Plaster for the Treatment of Patients With Trigeminal
           Neuralgia: A Retrospective Study

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      Authors: Bin Yu, Wei Zhang, Chunmei Zhao, Yan Xing, Lan Meng, Fang Luo
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Whether 5% lidocaine-medicated plaster (LMP) is a valuable therapeutic option for the treatment of trigeminal neuralgia (TN) is worth exploring. If LMP is proven effective for TN, positive predictors of the analgesic effects of LMP warrant further investigation.Objective:To evaluate the efficacy and safety of LMP for the treatment of TN, and to explore the predictive factors for the treatment efficacy of LMP.Methods:This is a retrospective and observational study. We analyzed the efficacy of LMP for the treatment of TN between March 2019 and January 2022. The follow-up time was approximately 2 weeks, 1 month, 2 months, and 3 months after LMP treatment. The LMP response was considered the Barrow Neurological Institute (BNI) score of I to III and an improvement in BNI of at least I grade from pretreatment baseline. Univariable and multivariable logistic analyses were performed to identify the predictive factors for LMP response.Results:A total of 103 patients were included and analyzed in this study. LMP was effective in some TN patients, with an efficacy rate of 21.4%, 21.4%, 18.4%, and 16.5% after 2 weeks, 1 month, 2 months, and 3 months of LMP treatment, respectively. The overall adverse event rate associated with LMP was 5.8%, and the reported adverse events were all skin reactions. Facial trigger points (odds ratio [OR] = 0.25, 95% confidence interval [CI] = 0.07-0.86, P = 0.03) and a lower BNI score (OR = 0.37, 95% CI = 0.07-0.87, P = 0.01) were identified as potential predictors for initial efficacy (2-week follow-up) of LMP treatment.Conclusions and Relevance:LMP has been shown to provide effective and sustained analgesia in some TN patients with minimal risk of systemic adverse reactions. Patients with facial trigger points and mild to moderate pain are more likely to benefit from LMP treatment. Our data suggest that LMP may be an effective treatment option for patients with the aforementioned characteristics of TN.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-30T06:43:01Z
      DOI: 10.1177/10600280221120457
       
  • Timing of Vasopressin Addition to Norepinephrine and Efficacy Outcomes in
           Patients With Septic Shock

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      Authors: Allison L. Brask, Shelby M. Shemanski, Tyler E. Barnes, Ashley K. Holmes
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Current guidelines recommend norepinephrine as the first-line vasopressor in septic shock followed by addition of vasopressin to achieve a goal mean arterial pressure. Limited evidence exists evaluating how the timing of vasopressin addition affects clinical outcomes in septic shock.Objective:The objective of this study was to determine whether the timing of the addition of vasopressin to norepinephrine affects shock resolution.Methods:This was a multi-site, single system, retrospective cohort, institutional review board (IRB)-approved study examining adult patients with septic shock who received norepinephrine and vasopressin. Patients were divided and statistically analyzed in two subgroups: early vasopressin addition (
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-30T06:37:25Z
      DOI: 10.1177/10600280221118903
       
  • Perioperative Antiplatelet Bridging With Cangrelor: A Cohort Study and
           Narrative Review

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      Authors: Alok Salgia, Chelsea K. Krueger, Michael A. Gillette
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:In patients who received a cardiac stent, practice guidelines recommend dual antiplatelet therapy (DAPT). However, an urgent procedure may be required necessitating interruption of DAPT. Intravenous cangrelor was previously shown to be an alternative due its short-half life and quick onset/offset.Objective:To determine the safety and effectiveness of cangrelor bridging for patients undergoing invasive procedures in a veteran population.Methods:Retrospective cohort of patients from Michael E. DeBakey VA Medical Center and the VA North Texas Health Care Systems who underwent perioperative cangrelor bridging. The primary outcome was the incidence of bleeding using the Bleeding Academic Research Consortium (BARC) criteria. The secondary outcome was a composite of nonfatal stroke, myocardial infarction (MI), mortality, and unplanned revascularization within 30 days. A narrative review was also performed to summarize cangrelor bridging for noncardiac invasive procedure.Results:There were 41 patients that met the eligibility criteria. Patients were predominantly Caucasian (57.5%) men with a median age of 70 years. The median duration on cangrelor bridging was 2.6 days with 11 and 30 patients undergoing cardiac and noncardiac invasive procedures, respectively. Nine patients (22%) had a bleeding event of which 8 were minor. One was severe due to significant iliopsoas hematoma following drain placement. All bleeding events occurred postoperatively except for 2 perioperative events that occurred during orthopedic procedures. Ischemic events up to 30 days occurred in 3 patients (7.3%) which consisted of 1 (2.4%) nonfatal MI requiring revascularization and 2 (4.9%) deaths, 1 of which was sudden cardiac.Conclusion and Relevance:This study suggests that cangrelor bridging may be a reasonable alternative to holding oral P2Y12 inhibitors in patients requiring interruption of antiplatelet therapy for an urgent surgery/invasive procedure.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-25T06:26:48Z
      DOI: 10.1177/10600280221120310
       
  • Major Bleeding Postadministration of Tenecteplase Versus Alteplase in
           Acute Ischemic Stroke

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      Authors: Mary N. Walton, Leslie A. Hamilton, Sonia Salyer, Brian F. Wiseman, Ann M. Forster, A. Shaun Rowe
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Tenecteplase is a genetically engineered fibrinolytic with growing interest in the treatment of acute ischemic stroke. Compared to alteplase, tenecteplase is effective for neurologic improvement following ischemic stroke in patients with large vessel occlusions who are eligible for thrombectomy and for mild ischemic strokes with National Institutes of Health Stroke Scale of 0 to 5.Objective:The purpose of this study is to determine if safety outcomes are different in patients receiving tenecteplase and alteplase for acute ischemic stroke.Methods:This retrospective cohort reviewed all patients who received alteplase or tenecteplase from January 2019 to December 2020. Patients admitted before April 28, 2020, received alteplase intravenous bolus over 1 minute followed by an infusion over 1 hour, for a total of 0.9 mg/kg. Patients admitted after this date received tenecteplase 0.25 mg/kg as an intravenous bolus over 5 to 10 seconds. Any patient transferring from an outside facility was excluded. The primary outcome was major bleeding.Results:There was no significant difference in major bleeding between alteplase and tenecteplase (40 [18%] vs 21 [18.1%], P = 0.985). There was no significant difference in all-cause inpatient mortality for alteplase versus tenecteplase (10 [5%] vs 5 [4%], P = 0.934) or in adverse events between the groups (22 [9%] vs 14 [12%], P = 0.541) for alteplase and tenecteplase, respectively.Conclusions and Relevance:Tenecteplase had similar rates of major bleeding versus alteplase and may be a reasonable alternative in the treatment of acute ischemic stroke.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-25T06:24:28Z
      DOI: 10.1177/10600280221120211
       
  • Evaluating the Incidence and Risk Factors for Acute Cellular Rejection in
           a Steroid Sparing Liver Transplant Center

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      Authors: Xunjie Zhang, Alicia Lichvar, Christine Chan, David Choi
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Corticosteroids has been the mainstay of immunosuppression (IMS) following liver transplant (LT). With the advent of more potent IMS, complete steroid withdrawal has become possible after LT. However, there is limited data regarding the incidence and risk factors for acute cellular rejection (ACR) in LT recipients on steroid sparing regimens.Objective:To identify the incidence and risk factors of ACR in LT recipients at an urban LT center utilizing a steroid-sparing IMS regimen.Methods:This was a single center retrospective study evaluating incidence of ACR in adults (>18 years) who received a LT between 01/01/2008 and 6/30/2019 at a steroid-sparing liver transplant center. Data between patients who had ACR and patients who did not were compared and risk factors were identified by multivariate logistic linear regression.Results:A total of 266 patients were included in this analysis, of which 18.4% experienced ACR within the first year of LT. Median time to first ACR was 134 (interquartile range [IQR]: 34-246) days. Black race (odds ratio [OR]: 4.39, P < 0.001), continued need for prednisone (OR: 2.80, P = 0.015) and cytomegalovirus (CMV) viremia (OR: 6.27, P < 0.001)) were independent risk factors for ACR. Tacrolimus use was associated with less ACR (OR: 0.33, P = 0.013).Conclusion and Relevance:Steroid sparing regimens for IMS post-LT were not associated with an increased incidence of ACR when compared to reported ACR rates in literature. Potential risk factors for ACR include Black race, the use of prednisone maintenance IMS therapy, and CMV viremia.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-25T06:16:42Z
      DOI: 10.1177/10600280221120059
       
  • Maribavir for the Management of Cytomegalovirus in Adult Transplant
           Recipients: A Review of the Literature and Practical Considerations

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      Authors: Hanna L. Kleiboeker, Jillian L. Descourouez, Lucas T. Schulz, Didier A. Mandelbrot, Jon S. Odorico, John P. Rice, Christopher M. Saddler, Jeannina A. Smith, Margaret R. Jorgenson
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review the efficacy and safety of maribavir for management of cytomegalovirus (CMV) in solid organ transplant recipients.Data Sources:A literature search of PubMed and the Cochrane Controlled Trials Register (1960 to early July 2022) was performed using the following search terms: maribavir, 1263W94, and cytomegalovirus.Study Selection and Data Extraction:All relevant English-language studies were reviewed and considered, with a focus on phase 3 trials.Data Synthesis:Maribavir, an orally available benzimidazole riboside with minimal adverse effects, was originally studied for universal prophylaxis in phase 3 trials but failed to demonstrate noninferiority over placebo and oral ganciclovir. It was effective for preemptive treatment in a dose-finding Phase 2 study. Maribavir is FDA approved for treatment of refractory/resistant CMV infection based on improved response rate at 8 weeks compared with investigator-assigned therapy (IAT) when initiated at median viral loads less than approximately 10 000 IU/mL (55.7% vs 23.9%, P < 0.001). Recurrence after 8-week treatment for refractory/resistant CMV was high (maribavir 50% vs IAT 39%). Significant drug interactions exist and must be managed by a pharmacotherapy expert to prevent harm.Relevance to Patient Care and Clinical Practice:The addition of maribavir to the antiviral armamentarium should improve the management of refractory/resistant CMV, allowing early transition from toxic, high-cost, intravenous agents such as foscarnet and outpatient management. Optimal timing of initiation, duration, and potential alternative uses are unclear.Conclusion:Future studies are needed to fully elucidate the role of maribavir in the management of CMV after transplant.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-25T05:44:12Z
      DOI: 10.1177/10600280221118959
       
  • Rate of Inpatient Hypoglycemia Following a 1:1 Dose Interchange Between
           Concentrated Insulin Glargine to Insulin Detemir

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      Authors: S. D. Wulfe, K. M. Janzen, J. Addison, D. Kelley
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundInsulin remains a mainstay of treating hyperglycemia in an acute setting. Insulin glargine 300 units/mL (Toujeo, iGlar300) has a different pharmacokinetic profile than 100 units/mL basal insulins, such as insulin detemir (iDet100) and iGlar100. While conversion from iGlar300 to iGlar100 requires a 20% dose decrease, there is currently no recommended interchange from iGlar300 to iDet100.ObjectiveCompare the incidence of hypoglycemia in patients who received a 1:1 unit interchange from home iGlar300 or iGlar100 to iDet100 while admitted.MethodsA retrospective study was conducted to evaluate adults within a multi-site network admitted between May and December 2019. Patients were included if they received at least one dose of iDet100 following interchange from home iGlar300 or iGlar100. The primary endpoint was the incidence of hypoglycemic events following a 1:1 interchange of iGlar300 vs. iGlar100 to inpatient iDet100. Secondary outcomes include overall hypoglycemic events, time to hypoglycemia, and doses given before hypoglycemia.ResultsOf 615 patients, 394 received a 1:1 unit interchange to iDet100 (52 from iGlar300 and 342 from iGlar100). Incidence of hypoglycemic events was significantly higher in those with a 1:1 interchange from iGlar300 versus iGlar100 (36.5% vs. 18.7%, p = 0.007). Significant differences were observed in overall hypoglycemic events, time to hypoglycemia, and number of doses given before hypoglycemic event.Conclusion and RelevanceA 1:1 unit interchange from iGlar300 to iDet100 led to a higher incidence of hypoglycemic events compared to those interchanged from iGlar100. Dose reduction should be considered when transitioning from home iGlar300 to iDet100 in the inpatient setting.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-22T05:21:47Z
      DOI: 10.1177/10600280221119187
       
  • Efficacy and Safety of Erenumab, Galcanezumab, and Fremanezumab in the
           Treatment of Drug-Resistant Chronic Migraine: Experience in Real Clinical
           Practice

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      Authors: Lorenzo Cantarelli, Diana Pestana Grafiña, Amanda Gonzalez Perez, Sara García Gil, Fernando Gutiérrez Nicolás, Emma Ramos Santana, Marco Antonio Navarro Dávila, Sheila María Otazo Pérez, Gloria Calzado Gómez, Sergio Perez Reyes, Gloria Julia Nazco Casariego
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Due to the recent introduction of new biologic drugs for chronic migraine, a global evaluation in real clinical practice is necessary.Objective:The objective was to evaluate the effectiveness and safety in real clinical practice of drugs targeting the calcitonin gene-related peptide receptor (CGRPr) in patients with chronic migraine.Methods:Single-center, restrospective study (2019-2022), including patients with chronic migraine treated with erenumab, galcanezumab, or fremanezumab. Effectiveness variables were recorded, namely, number of migraine headache days per month (MHD), Migraine Disability Assessment Scale (MIDAS) score, and Headache Impact Test–6 (HIT-6) score, assessing changes at week 12, 24 from baseline. Toxicity was recorded following the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.Results:In all, 104 patients were included (46.2% erenumab, 41.3% galcanezumab, 12.5% fremanezumab). A reduction in MHD, MIDAS, and HIT-6 was achieved at weeks 12 and 24 with erenumab (p75% at week 24 than those intensified; P = 0.041). There was no difference in efficacy (P = 0.154) or improvement in quality of life (P = 0.783, P = 0.150), but there was greater toxicity (P < 0.001) among nonresponders with erenumab 70 mg versus erenumab 140 mg.Conclusions:The results confirm the effectiveness and safety of anticalcitonin gene-related peptide (CGRP) drugs in real clinical practice. However, the study shows little benefit from erenumab intensification, with similar effectiveness and worse tolerability than the standard dose.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-18T10:00:18Z
      DOI: 10.1177/10600280221118402
       
  • Accuracy of 4 Free Online Dosing Calculators in Predicting the Vancomycin
           Area Under the Concentration-Time Curve Calculated Using a 2-Point
           Pharmacokinetic Approach

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      Authors: Sarah N. Belz, Robert W. Seabury, Jeffrey M. Steele, William Darko, Christopher D. Miller, Luke A. Probst, Wesley D. Kufel
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Free online adaptive vancomycin dosing calculators are available to estimate area under the concentration-time curve (AUC), but the accuracy of predicting vancomycin AUC using these calculators compared with using a 2-point pharmacokinetic approach has not been described.Objective:To evaluate the accuracy of calculator-predicted AUC (cpAUC) using 4 free online calculators compared with reference AUC (rAUC), and to assess pharmacists’ impressions of the ease of use.Methods:Vancomycin AUC was estimated using (1) the reference method via the Sawchuk-Zaske method and linear-logarithmic trapezoidal rule using 2 steady-state postdistributional vancomycin serum concentrations and (2) 4 free online vancomycin dosing calculators including ClinCalc, VancoPK, TDMx, and DMC. Accuracy was calculated by dividing cpAUC by rAUC. Ease of cpAUC estimation was determined by using a 10-point Likert scale.Results:All 4 calculators had a median cpAUC accuracy ranging from 89% to 110%. Concordance between cpAUC and rAUC determinations of AUC 600 mg·h/L occurred 63.3% to 71.4% and 74.5% to 78.6% of the time, respectively. Pharmacist investigators agreed that ClinCalc and VancoPK calculators were easiest to use.Conclusion and Relevance:cpAUC accuracy varied among the 4 calculators, but all consistently identified patients with an rAUC 600 mg·h/L at comparable frequencies. All 4 calculators demonstrated some imprecision based on their wide 95% CIs and potential inaccuracies in predicting an rAUC 600 mg·h/L. Clin Calc and VancoPK were most user friendly based on our pharmacists’ impressions.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-18T09:58:22Z
      DOI: 10.1177/10600280221117256
       
  • Interventions, Barriers, and Proposed Solutions Associated With the
           Implementation of a Protocol That Uses Clinical Decision Support and a
           Stress Biomarker Test to Identify ICU Patients at High-Risk for Drug
           Associated Acute Kidney Injury

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      Authors: Victoria L. Williams, Pamela L. Smithburger, Allison N. Imhoff, Lara M. Groetzinger, Colleen M. Culley, Clayton X. Burke, Raghavan Murugan, Phillip E. Lamberty, Mujtaba Mahmud, Neal J. Benedict, John A. Kellum, Sandra L. Kane-Gill
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Damage biomarkers are helpful in early identification of patients who are at risk of developing acute kidney injury (AKI). Investigations are ongoing to identify the optimal role of stress/damage biomarkers in clinical practice regarding AKI risk prediction, surveillance, diagnosis, and prognosis.Objective:To determine the impact of utilizing a clinical decision support system (CDSS) to guide stress biomarker testing in intensive care unit (ICU) patients at risk for drug-induced acute kidney injury (D-AKI).Methods:A protocol was designed utilizing a clinical decision support system (CDSS) alert to identify patients that were ordered 3 or more potentially nephrotoxic medications, suggesting risk for progressing to AKI from nephrotoxic burden. Once alerted to these high-risk patients, the pharmacist determined if action was needed by ordering a stress biomarker test, tissue inhibitor of metalloproteinase-2-insulin-like growth factor-binding protein 7 (TIMP-2•IGFBP7). If the biomarker test result was elevated, the pharmacist provided nephrotoxin stewardship recommendations to the team. Pharmacists recorded the response to the clinical decision support alert, ordering, and interpreting the TIMP-2•IGFBP7, and information regarding clinical interventions. An alert in conjunction with TIMP-2•IGFBP7 as a strategy for AKI risk prediction and stimulant for patient care management was assessed. In addition, barriers and solutions to protocol implementation were evaluated.Results:There were 394 total activities recorded by pharmacists for 345 unique patients. Ninety-three (93/394; 23.6%) actionable alerts resulted in a TIMP-2•IGFBP7 test being ordered. Thirty-one TIMP-2•IGFBP7 results were>0.3 (31/81; 38.3%), suggesting a high-risk of progression to AKI, which prompted 191 pharmacist/team interventions. On average, there were 1.64 interventions per patient in the low-risk patients, 3.43 in high-risk patients, and 3.75 in the highest-risk patients.Conclusion and Relevance:Stress biomarkers can be used in conjunction with CDSS alerts to affect therapeutic decisions in ICU patients at high-risk for D-AKI.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-13T06:44:50Z
      DOI: 10.1177/10600280221117993
       
  • A Review of Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical
           Cancer

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      Authors: Nathan Heitz, Samuel C. Greer, Zachery Halford
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To evaluate the safety and efficacy of tisotumab vedotin-tftv (TV), a first-in-class vectorized anti-tissue factor (TF) antibody-drug conjugate (ADC), for the treatment of recurrent or metastatic cervical cancer.Data Sources:A literature search of ClinicalTrials.gov, Embase, and PubMed was conducted using the terms tisotumab vedotin AND cervical cancer from inception to June 30, 2022.Study Selection and Data Extraction:All applicable publications, package inserts, meeting abstracts, and clinical trials involving TV in the treatment of cervical cancer were reviewed.Data Synthesis:TV is a fully human TF-specific monoclonal antibody conjugated to monomethyl auristatin E, which serves as a highly potent cytotoxic payload. In the pivotal phase II InnovaTV 204 clinical trial, TV demonstrated an objective response rate of 24% (95% confidence interval [CI], 16%-33%). The mean duration of response was 8.3 months. Common toxicities included abdominal pain, alopecia, conjunctivitis, constipation, decreased appetite, diarrhea, dry eye, epistaxis, nausea/vomiting, and peripheral neuropathy. Unique and/or serious adverse events warranting careful monitoring include ocular complications, hemorrhaging, peripheral neuropathies, fetal-embryo toxicity, pneumonitis, and immunogenicity.Relevance to Patient Care and Clinical Practice:Recurrent or metastatic cervical cancer remains a high-risk disease with limited treatment options. Using ADCs to target tumors with aberrant expression of TF appears to be a viable treatment strategy.Conclusions:TV is the first Food and Drug Administration–approved TF-directed ADC. With a manageable safety profile and promising anticancer activity, TV warrants consideration as a novel targeted agent for the treatment of recurrent or metastatic cervical cancer. Further studies are required to determine the optimal place in therapy for TV.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-13T05:12:06Z
      DOI: 10.1177/10600280221118370
       
  • Use of a Novel Standardized Administration Protocol Reduces Agitation Pro
           Re Nata (PRN) Medication Requirements: The Birmingham Agitation Management
           (BAM) Initiative

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      Authors: Bradley G. Burk, Peter Penherski, Kendall Snider, Lesli Lewellyn, Lisa Mattox, Shea Polancich, Rachel Fargason, Barry Waggoner, Elizabeth Caine, Wren Hand, Reid M. Eagleson, Badari Birur
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Agitation management is a principal challenge on inpatient psychiatric units. Overreliance on common prescribing strategies of pro re nata (PRN) medication administration is problematic, given the tendencies to have overlapping or unclear indications.Objective:Piloted project to determine whether a standardized protocol for agitation intervention may reduce PRN medication administration.Methods:The Birmingham Agitation Management (BAM) interdisciplinary team uniquely connected the Brøset Violence Checklist (BVC) for assessment of agitation severity to a standardized PRN medication order set. Nurses on the piloted unit were trained on how to score the BVC and administer medications. Patients were assessed by the BVC every 4 hours and, based on their score, would receive no medication, low-dose benzodiazepine, high-dose benzodiazepine, or high-dose benzodiazepine plus antipsychotic. The primary end point compared the number of PRNs administered after novel protocol implementation with a retrospective cohort. Secondary measures included analysis of medication-related effects, seclusion, and physical restraint rates.Results:377 patients were included in the final analyses (184 pre-BAM, 193 BAM intervention group). No significant differences were seen in patient characteristics between groups. The total number of PRNs administered decreased by 42.5%, with both the mean and median number of administrations decreasing significantly (95% confidence interval [CI] = [1.68-5.75]; P < 0.001). A trend was noted between the number of PRNs administered and seclusion rates, but did not reach statistical significance (95% CI = [–7.28 to 60.31]; P = 0.124).Conclusions:In seemingly the first initiative of its kind, we found that a standardized agitation management protocol can help decrease the total number of PRN administrations for agitation without worsening of restraint rates and may possibly reduce the risk of adverse effects. These results require validation in specific, larger populations.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-11T10:31:52Z
      DOI: 10.1177/10600280221117813
       
  • Comment: Comparison of 2-Bag Versus 3-Bag N-Acetylcysteine Regimens for
           Pediatric Acetaminophen Toxicity

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      Authors: Anselm Wong
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-11T09:42:14Z
      DOI: 10.1177/10600280221117323
       
  • Mavacamten, a First-in-Class Cardiac Myosin Inhibitor for Obstructive
           Hypertrophic Cardiomyopathy

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      Authors: Joseph D. Dalo, Nissen D. Weisman, C. Michael White
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To assess mavacamten’s role in hypertrophic cardiomyopathy treatment.Data Sources:In addition to clinical guidelines, package inserts, and general reviews, we searched PubMed using the term mavacamten from inception to June 11, 2022.Study Selection and Data Extraction:English language studies describing mavacamten’s mechanism of action, pharmacokinetics, drug interactions, clinical and economic outcomes, and adverse events.Data Synthesis:Mavacamten reduces left ventricular outflow obstruction and New York Heart Association functional class while improving Kansas City Cardiomyopathy Questionnaire-Clinical Summary Scores in patients with obstructive hypertrophic cardiomyopathy. With an acquisition cost of $245.20 per capsule, it would cost $1.2 million for every additional quality-adjusted life year. In those with unobstructive hypertrophic cardiomyopathy, there were improvements in N-terminal probrain natriuretic peptide and high-sensitivity cardiac troponin biochemical markers. Mavacamten is a substrate for CYP2C19 and CYP3A4, and a CYP enzyme inducer.Relevance to Patient Care and Clinical Practice:Patients with obstructive hypertrophic cardiomyopathy and an ejection fraction ≥55% have a new option if they remain symptomatic despite maximally tolerated β-blocker or non-dihydropyridine calcium channel blocker therapy. It is an alternative to disopyramide therapy, which has poor patient tolerance, or septal reduction therapies, which are invasive. However, mavacamten is not cost-effective and its role in nonobstructive hypertrophic cardiomyopathy is not well established.Conclusions:Mavacamten is a new option for patients with refractory obstructive hypertrophic cardiomyopathy and an ejection fraction ≥55% but its pricing makes therapy not cost-effective. Final health outcomes are not fully elucidated and additional studies are needed to determine long-term effects.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-11T07:15:51Z
      DOI: 10.1177/10600280221117812
       
  • Difelikefalin: A New κ-Opioid Receptor Agonist for the Treatment of
           Hemodialysis-Dependent Chronic Kidney Disease–Associated Pruritus

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      Authors: Justin Fugal, Sister Michaela Serpa
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review data for difelikefalin (Korsuva) intravenous solution for management of moderate-to-severe pruritus in hemodialysis (HD) patients.Data Sources:Literature search of PubMed (January 1946-May 2022) and SCOPUS (January 1946-May 2022) was performed using the terms: Korsuva, CR845, and difelikefalin. Additional information sources include ClinicalTrials.gov, prescribing information, meeting posters, and references of identified articles.Study Selection and Data Extraction:Clinical trials and articles evaluating difelikefalin for chronic kidney disease–associated pruritis (CKD-aP) in HD patients.Data Synthesis:Difelikefalin is a peripherally acting κ-opioid receptor agonist with antipruritic effects for HD patients with moderate-to-severe CKD-aP. A phase 3 study showed significant improvement of patient itch intensity and itch-related quality of life (QOL) when compared with placebo. More patients had decreased pruritus on the 24-hour Worst Itch Intensity Numerical Rating Scale with difelikefalin (49.1%) compared with placebo (27.9%, P < 0.001). A positive effect was seen with or without use of additional antipruritic agents. Common adverse events include diarrhea, dizziness, and vomiting; there were no signs of physical dependence or centrally acting opioid effects (euphoria, hallucinations).Relevance to Patient Care and Clinical Practice:Difelikefalin reduced itch intensity and improved QOL for patients with CKD-aP. Whether the benefit is continued long-term as well as how it compares with other effective agents is currently unknown.Conclusion:Difelikefalin is the only Food and Drug Administration–approved treatment for moderate-to-severe CKD-aP with additional research into its benefit in this and other types of pruritus ongoing.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-09T07:04:46Z
      DOI: 10.1177/10600280221115889
       
  • Safety and Efficacy of Ceftriaxone in the Treatment of
           Methicillin-Susceptible Staphylococcus aureus Bloodstream Infections: A
           Noninferiority Retrospective Cohort Study

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      Authors: Anisha Ganguly, Carolina de la Flor, Kristin Alvarez, L. Steven Brown, Norman S. Mang, Jillian Smartt, Helen King, Trish M. Perl, Hector Filizola, Kavita P. Bhavan
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Antistaphylococcal penicillins and cefazolin are the treatments of choice for methicillin-susceptible Staphylococcus aureus (MSSA) infections, requiring multiple doses daily. At Parkland, eligible uninsured patients with MSSA bloodstream infections (BSI) receive self-administered outpatient parenteral antimicrobial therapy (S-OPAT). Ceftriaxone was used in a cohort of S-OPAT patients for ease of once-daily dosing.Objective:A retrospective study was conducted to evaluate clinical outcomes for patients discharged with ceftriaxone versus cefazolin to treat MSSA BSI.Methods:A retrospective cohort noninferiority study design was used to assess treatment efficacy of ceftriaxone versus cefazolin among Parkland S-OPAT patients treated from April 2012 to March 2020. Demographic, clinical, and treatment-related adverse events data were collected. Clinical outcomes included treatment failure as defined by repeat positive blood culture or retreatment within 6 months, all-cause 30-day readmission rates, and central line–associated bloodstream infection (CLABSI) rates.Results:Of 368 S-OPAT patients with MSSA BSI, 286 (77.7%) received cefazolin, and 82 (22.3%) received ceftriaxone. Demographics and comorbidities were similar for both groups. There were no treatment failures in the ceftriaxone group compared with 4 (1%) in the cefazolin group (P = 0.58). No difference in 30-day readmission rate between groups was found. The CLABSI rates were lower in ceftriaxone group (2%) compared with cefazolin (11%; P = 0.02). Limitations include retrospective cohort design.Conclusions:Ceftriaxone was found to be noninferior to cefazolin in this study. Our findings suggest that ceftriaxone is a safe and effective treatment of MSSA BSI secondary to osteoarticular or skin and soft tissue infections when used in the S-OPAT setting.Poster abstract:OFID on 2018 Nov; 5(Suppl 1): S316: doi: 10.1093/ofid/ofy210.894.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-09T07:03:26Z
      DOI: 10.1177/10600280221115460
       
  • Co-prescribing of Central Nervous System–Active Medications for COPD
           Patients: Impact on Emergency Room Visits and Hospitalization

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      Authors: Akhil Sood, Yong-Fang Kuo, Jordan Westra, Gulshan Sharma, Mukaila A. Raji
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Anxiety and chronic pain are common comorbidities in patients with chronic obstructive pulmonary disease (COPD), which are frequently managed with benzodiazepines (BZDs) and opioids, respectively.Objective:The purpose of this study was to determine whether different combinations of opioids, BZD, and their substitutes—gabapentinoids (GABA) and selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs)—are associated with lower risk of acute respiratory events in COPD patients with co-occurring chronic pain and anxiety.Methods:This retrospective cohort study used a nationally representative sample of Medicare beneficiaries with COPD, chronic pain, and anxiety. Patients were grouped based on drug combination (opioid + BZD/Z-hypnotics, opioid + GABA, opioid + SSRI/SNRI, BZD/Z-hypnotics + GABA, BZD/Z-hypnotics + SSRI/SNRI, GABA + SSRI/SNRI, or ≥3 drugs). The primary outcome was emergency room (ER) visit or hospitalization due to acute respiratory events assessed up to 180 days following initiation of drug combination. Overdose secondary to central nervous system (CNS)–related drugs was also assessed up to 180 days following initiation of drug combination.Results:The drug combination opioid + GABA was associated with decreased risk for ER visit (hazard ratio [HR] = 0.73; 95% CI = 0.61-0.87) and hospitalization (HR = 0.69; 95% CI = 0.55-0.85). Opioid + SSRI/SNRI also showed decreased risk for ER visit (HR = 0.84; 95% CI = 0.71-0.99). There was no significant difference in risk for CNS-related drug overdose among different drug combinations compared with opioid + BZD/Z-hypnotics.Conclusion and Relevance:Opioids in combination with GABA and SSRI/SNRI demonstrate relatively lower risk for acute respiratory events among patients with COPD and comorbid chronic pain and anxiety. The findings emphasize the need for multimodal management in this vulnerable population.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-09T07:01:44Z
      DOI: 10.1177/10600280221113299
       
  • Effectiveness and Safety of Enoxaparin Versus Unfractionated Heparin as
           

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      Authors: Lina H. AlLehaibi, Mukhtar Alomar, Abdulaziz Almulhim, Sarah Al-Makki, Nazar R. Alrwaili, Shahad Al-Bassam, Semat Alsultan, Jenan Al Saeed, Mohammad Alsheef, Ivo Abraham, Ahmad Alamer
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Coronavirus 2019 (COVID-19) patients are at risk of thrombosis. Literature that compares the effectiveness of enoxaparin to unfractionated heparin (UFH) in COVID-19 patients is scarce.Objective:We aimed to evaluate the effectiveness and safety of enoxaparin compared with UFH when used at their standard/intermediate dosing in COVID-19 patients.Methods:This was a retrospective study conducted at a large COVID-19 center located in Eastern Province, Saudi Arabia. Confirmed COVID-19 cases (≥18 years old) admitted between January and December 2020 were randomly screened for inclusion. Exclusion criteria were patients receiving therapeutic anticoagulation, on chronic anticoagulation, had active bleeding, a platelet count
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-09T05:39:38Z
      DOI: 10.1177/10600280221115299
       
  • Abrupt Discontinuation Versus Taper of Hydrocortisone in Patients With
           Septic Shock

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      Authors: Shannon Carabetta, Bryan Allen, Chad Cannon, Totty Johnson
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Although not mentioned in the most recent guidelines, the 2016 Surviving Sepsis Campaign guidelines recommend to taper corticosteroids once vasopressors are no longer needed; however, at the time of publication, there were no studies comparing taper versus abrupt discontinuation of corticosteroids.Objectives:The purpose of this study was to further evaluate the impact of abrupt versus taper discontinuation of corticosteroids in septic shock.Methods:This was a retrospective cohort study that included patients who received an initial dose of 200 to 300 mg of hydrocortisone for septic shock. Participants were then divided into “abrupt” and “taper” groups. The primary outcome assessed was hemodynamic instability during taper or within 72 hours of the last corticosteroid dose. Secondary outcomes included intensive care unit (ICU) and hospital length of stay, incidence of hyperglycemia or hypernatremia, and in-hospital mortality.Results:The primary outcome of reinitiation of vasopressor therapy occurred in a larger proportion of patients in the taper group compared with the abrupt group (21.9% vs 10.7%). The ICU length of stay (7.6 days abrupt vs 9 days taper) and hospital length of stay (14.9 vs 15.3 days) were similar between groups. There was a statistically significant increase in patients who experienced hyperglycemia within 24 hours of the last corticosteroid dose in the abrupt group. All other secondary outcomes were similar between groups.Conclusions:The abrupt discontinuation of hydrocortisone in the treatment of septic shock was associated with a nonstatistically significant 50% absolute reduction in the need for vasopressor reinitiation.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-05T05:33:51Z
      DOI: 10.1177/10600280221117156
       
  • Systematic Review of Psychiatric Adverse Effects Induced by Chloroquine
           and Hydroxychloroquine: Case Reports and Population Studies

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      Authors: Fernanda Talarico, Sucheta Chakravarty, Yang S. Liu, Andrew J. Greenshaw, Ives Cavalcante Passos, Bo Cao
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To perform a systematic review on the psychiatric adverse effects of chloroquine (CQ) and hydroxychloroquine (HCQ); to summarize what is known about psychiatric adverse effects of these drugs; to compare clinical trials, populational studies, and case report studies; and to increase awareness of the potential psychiatric adverse effects of these drugs.Data Sources:A literature search of PubMed, Scopus, and Web of Science was performed to identify manuscripts published between December 1962 and June 2022. Search terms included CQ, HCQ, psychiatry, psychosis, depression, anxiety, bipolar disorder, delirium, and psychotic disorders.Study Selection and Data Extraction:Relevant studies included reports of adverse effects after CQ or HCQ ingestion.Data Synthesis:The current literature presents evidence for a risk of short-term psychiatric adverse effects induced by either CQ or HCQ. However, the populational-level studies presented some limitations regarding the voluntary response in survey data, self-report adverse effects, and placebo group reporting similar symptoms to the case group. Thus, populational-level studies addressing the discussed limitations and the nature and extent of possible psychiatric adverse effects are needed.Relevance to Patient Care and Clinical Practice:Most of the patients who developed such adverse effects did not report a family history of psychiatric disease. The frequency of psychiatric adverse effects depends on the patient’s biological sex, age, and body mass index, but not on the drug dosage.Conclusions:Based on clinical trials and case reports, the current literature presents evidence for a risk of short-term psychiatric adverse effects induced by either drug.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-05T05:29:15Z
      DOI: 10.1177/10600280221113572
       
  • Upadacitinib for the Treatment of Rheumatoid Arthritis: An Extensive
           Review

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      Authors: Eric G. Boyce, Edward L. Rogan, May C. Lui
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objectives:To review the characteristics, efficacy, safety, pharmacoeconomics, and place in therapy of upadacitinib, a Janus kinase (JAK) inhibitor, in the treatment of rheumatoid arthritis (RA).Data Sources:PubMed (January 2003-May 2022) was searched using upadacitinib and ABT-494.Study Selection and Data Extraction:Human studies published in peer-reviewed publications in English were the primary sources for efficacy and safety data.Data Synthesis:In randomized, double-blind, controlled clinical studies, upadacitinib demonstrated statistically significant improvement in RA symptoms as monotherapy and in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) when compared with csDMARD monotherapy or to adalimumab or abatacept in combination with csDMARD therapy in patients with RA. American College of Rheumatology 20% response rates were 68% to 79% for upadacitinib monotherapy and 64% to 84% for upadacitinib plus csDMARD therapy, compared with 28% to 59% for csDMARD-only therapy and 63% to 74% for biologic DMARD (bDMARD) plus csDMARD therapy. Long-term extension studies demonstrated similar findings. Upadacitinib had similar rates of serious infections, herpes zoster, major cardiovascular events, and venous thromboembolic events as other JAK inhibitors. Upadacitinib was similar in cost to tofacitinib and twice as high as baricitinib based on current estimated costs to patients, but actual costs may vary.Relevance to Patient Care and Clinical Practice:Upadacitinib is an alternative therapy to other JAK inhibitors and bDMARDs in patients with moderate to severe RA who have had an inadequate response to a tumor necrosis factor inhibitor alone or in combination with a csDMARD.Conclusions:Upadacitinib is an effective JAK inhibitor for use in RA.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-03T06:25:33Z
      DOI: 10.1177/10600280221113092
       
  • The Efficacy and Safety of Sacubitril-Valsartan for the Treatment of Heart
           Failure in Adults: A Meta-Analysis

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      Authors: Qingshan Tian, Zhiping Xiong, HouDe Fan, Ting Ning, ZhenZhong Zheng
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:The current meta-analysis reviews the different randomized controlled trials (RCTs) on the use of sacubitril-valsartan (SV) thoroughly and assesses its effectiveness and safety as a drug for heart failure.Data Sources:Relevant articles for meta-analysis were searched from PubMed, MEDLINE, and Central databases using appropriate keywords.Study Selection and data extraction:Studies were included as per the predefined PICOS criteria. Demographic summary and event data change in heart conditions after drug intake and adverse effects of drugs under both the SV and control arms were determined. The risk of bias and comparative drug efficiency in terms of diagnostic odds ratio (OR) and risk ratio (RR) were determined using RevMan software.Data Synthesis:Ten RCTs with total 18 164 heart patients were included according to the inclusion criteria from the year 2015 to 2022. Included studies have patients of different age groups treated with either SV or control. For the change in number of patients with heart conditions after drug intake, we obtained the pooled OR of 0.80 (95% CI, 0.71-0.91) and pooled RR of 0.92 (95% CI, 0.88-0.96). The OR value less than 1 is indicative of high efficiency of SV in lowering the number of heart patients. All these values are statistically significant (P < 0.05) and suggested better recovery of patients with SV as compared with the control drugs with minimal risk and side effects.Conclusions:Data of included studies prove the efficacy and safety of SV for curing heart conditions. Therefore, the present evidence shows that SV is effective in the treatment of heart failure, reducing hospitalization and cardiovascular mortality, and that the adverse effects are comparable or fewer than those associated with other drugs used for this indication.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-02T07:20:24Z
      DOI: 10.1177/10600280221112158
       
  • LDL Reduction and Risk of Diabetes in Veteran Statin Users

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      Authors: Michaela Gross, Skai W. Schwartz, Yuri V. Sebastião, Amy Alman, Jason L. Salemi, Pragati Ghimire-Aryal, Philip Foulis
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:While statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) reduce cardiovascular morbidity and mortality, there is controversy regarding a potentially causal link with incident diabetes mellitus (DM). This association may partially be due to confounding by indication; since prescription guidelines encourage statin use among those diagnosed with DM, this may encourage their prescription among those with elevated blood glucose in the absence of DM diagnosis.Objective:The study examined the association between low-density lipoprotein (LDL) reduction following initiation of statin use and new-onset DM among veterans.Methods:We conducted a retrospective cohort study using data from the James A. Haley Veteran’s Hospital in Tampa, Florida. Patients with a visit between January 2007 and December 2011 were selected from the Veterans Information Systems and Technology Architecture system. Individuals were classified into categories of statin usage based on LDL reduction percentages and frequency-matched with controls. The primary outcome of interest was incident DM.Results:There was a significant association between LDL reduction and DM which was higher in lower LDL reduction groups (low response hazard ratio [HR]: 2.12, 95% CI: 1.62, 2.79; moderate response HR: 1.85, 95% CI: 1.40, 2.45; high response HR: 1.24, 95% CI: 0.74, 2.07).Conclusion and Relevance:This association may partially be explained by potential lifestyle modifications individuals may make when prescribed a statin which may reduce their risk of DM independent of the statin usage. This research has demonstrated a protective association between greater LDL reduction and DM at the individual level while reenforcing the evidence of an association between statin usage and DM.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-08-01T06:43:49Z
      DOI: 10.1177/10600280221115816
       
  • PreHevbrio: A New 3-Antigen Hepatitis B Vaccine for Adults

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      Authors: Allana J. Sucher, Brandon J. Sucher, Elias B. Chahine
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:The main objective of this article is to review the immunogenicity and safety of the 3-antigen recombinant hepatitis B vaccine (3A-HepB) in adults.Data Sources:A literature search was performed using PubMed and Google Scholar (2000 to June 2022) with the search terms hepatitis B vaccine and 3-antigen. Other resources included the Centers for Disease Control and Prevention, conference abstracts of liver meetings, the prescribing information, and the manufacturer’s website.Study Selection and Data Extraction:All English-language articles of studies assessing the immunogenicity and safety of 3A-HepB in humans were included.Data Synthesis:The 3A-HepB is licensed to prevent infection caused by all known subtypes of the hepatitis B virus in adults. It contains 3 hepatitis B surface antigens. The 3A-HepB has been shown to be noninferior to a single-antigen hepatitis B vaccine (1A-HepB). It is administered intramuscularly as a 3-dose series at 0, 1, and 6 months. The most commonly reported local reactions were injection site pain and tenderness, and the most commonly reported systemic reactions were headache, fatigue, and myalgia.Relevance to Patient Care and Clinical Practice:The introduction of 3A-HepB represents another step toward reducing the rates of new hepatitis B infections. However, clinical trials are needed to assess the immunogenicity of 3A-HepB in individuals at high-risk of nonresponse or low response to 1A-HepB, such as those with renal or hepatic impairment and those with altered immunocompetence.Conclusions:The 3A-HepB represents another vaccine to prevent hepatitis B in adults. It is safe and immunogenic but is associated with more adverse reactions than 1A-HepB.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-30T06:50:21Z
      DOI: 10.1177/10600280221114469
       
  • Evaluation of Pharmacist Impact on Patients Initiating Eculizumab for
           Atypical Hemolytic Uremic Syndrome in the Inpatient Setting

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      Authors: Paul Christopher Parish, Donald C. Moore, Megan Wayman, Justin Arnall
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-30T06:49:05Z
      DOI: 10.1177/10600280221113830
       
  • Dasiglucagon: A Novel Ready-to-Use Treatment for Severe Hypoglycemia

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      Authors: Angela L. Goodhart
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review dasiglucagon, a novel glucagon analogue approved by the Food and Drug Administration (FDA) for treatment of severe hypoglycemia in 2021.Data Sources:A literature search using the PubMed database (current to March 2022) and ClinicalTrials.gov was conducted using the search term dasiglucagon.Study Selection and Data Extraction:Relevant clinical data from English-language clinical trials were included.Data Synthesis:Dasiglucagon was studied in 3 clinical trials: 1 in patients aged 6 to 17 years and 2 in adults. In all 3 trials, dasiglucagon was found to provide clinically significant benefit in minutes to plasma glucose recovery compared with placebo (10 vs 40, P < 0.001; 10 vs 30, P < 0.001; 10 vs 35, P < 0.0001). Dasiglucagon was also comparable with reconstituted glucagon in plasma glucose recovery time measured from time of administration. The most common adverse events with dasiglucagon were nausea, vomiting, and headache; no serious safety events were observed.Relevance to Patient Care and Clinical Practice:Dasiglucagon is a novel glucagon analogue that is safe and effective for the treatment of severe hypoglycemia, and it is the first to be stable in aqueous solution. This makes dasiglucagon one of only 3 currently available glucagon treatment options that does not require reconstitution prior to administration.Conclusions:Dasiglucagon offers safe and effective treatment for severe hypoglycemia in patients aged 6 years and older. The stability of dasiglucagon in aqueous solution provides an additional option for emergency glucagon treatment that does not require reconstitution prior to administration.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-21T12:38:40Z
      DOI: 10.1177/10600280221108425
       
  • Evaluating the Impact of a Pharmacist-Led Antimicrobial Stewardship
           Intervention at Discharge in a Community, Nonteaching Hospital

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      Authors: Melanie M. Manis, Jeffrey A. Kyle, Dima Dajani, Kevin Pan, Peter J. Hughes, Georges Adunlin, Leland N. Allen, Charles E. Leonard
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Introduction:Approximately 30% to 50% of hospital discharge antimicrobials are inappropriate. Limited data exist on approaches to improve antimicrobial prescribing practices at the time of discharge from a community hospital. Objective: To assess the impact of a comprehensive pharmacist-led antimicrobial stewardship intervention at discharge.Methods:We conducted a quasi-experimental, pre-post study. A biphasic intervention took place on 2 medicine units from November 2019 to May 2020 at a community hospital. Baseline data were collected, followed by prescriber education on antimicrobial stewardship to both units (education phase). Next, a pharmacist-led intervention took place on one unit (intervention phase). The primary outcome was composite appropriateness of an oral antimicrobial prescribed to an adult at the time of discharge, defined by narrow spectrum of activity, dosing, and duration of therapy. The primary outcome was assessed using Fisher exact test.Results:Baseline composite appropriateness was 30% (n = 12) on the control unit and 30.8% (n = 20) on the intervention unit. From baseline to posteducation, no significant change in composite appropriateness was found on the control (30% to 26.7%, P = 0.256) or intervention (30.8% to 19.4%, P = 0.09) unit. There was no significant difference between the education to intervention phase (26.7% vs 35%, P = 0.254) on the control unit. On the intervention unit, a significant difference in composite appropriateness was found from the education to intervention phase (19.4% vs 47.8%, P = 0.017).Conclusion and Relevance:A pharmacist-led intervention improved appropriateness of oral antimicrobials prescribed at discharge. One-time education was insufficient for improving antimicrobial stewardship.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-19T09:17:24Z
      DOI: 10.1177/10600280221111795
       
  • Comment: A Retrospective Analysis of Creatinine-Based Kidney Function With
           and Without Sex Assigned at Birth Among Transgender Adults

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      Authors: Joshua S. Jue, Jonathan Weinreich, Mahmoud Alameddine
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-19T09:14:24Z
      DOI: 10.1177/10600280221111794
       
  • Reply: Balanced Salt Solutions for Critically Ill Patients: Nonplused and
           Back to Basics

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      Authors: Brian J. Kopp, Morgan Lenney, Brian L. Erstad
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-19T09:08:49Z
      DOI: 10.1177/10600280221111145
       
  • Intravesical VesiX as a Last Resort Therapy in Women With
           Antibiotic-Refractory Recurrent Urinary Tract Infections Contemplating
           Bladder Removal: A Preliminary Report

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      Authors: Philippe E. Zimmern, Namrata V. Sawant, Samuel S. Chang, Randolph W. Warner, Nicole J. De Nisco
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-15T11:56:45Z
      DOI: 10.1177/10600280221112111
       
  • Comment: Balanced Salt Solutions for Critically Ill Patients: Nonplused
           and Back to Basics

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      Authors: Anton Kasatkin, Aleksandr Urakov
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      The analysis of trial results of the intravenous fluids pharmacodynamics revealed problems common to all studies, such as varying study designs, clinical discretion for treatments, and heterogeneous patients. We believe that in the methodology of future research it is also necessary to pay due attention to the actual rather than theoretical physicochemical parameters of the solutions used, such as osmolality, pH, and potential excess of bases. Paying attention to these parameters of intravenous fluids will be useful for assessing their role in producing pharmacodynamic effects in critically ill patients.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-12T04:44:43Z
      DOI: 10.1177/10600280221111142
       
  • A Systematic Review and Meta-analyses of Longitudinal Studies on Drug
           Treatments for Gaucher Disease

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      Authors: Letícia Paula Leonart, Mariana M. Fachi, Beatriz Böger, Mariana Ribeiro da Silva, Renata Szpak, Natália Fracaro Lombardi, Maria Lucia Alves Pedroso, Roberto Pontarolo
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:Gaucher disease (GD) is a rare disorder linked to the absence/deficiency of glucocerebrosidase. GD can be treated by enzyme replacement therapy (ERT) and substrate reduction therapy (SRT). The aim of this systematic review (SR) is to assess the effectiveness of drugs used for GD treatment.Data Sources:Searches were conducted in PubMed and Scopus, in April 2021. The search strategies encompassed the name of the disease and of the drug treatments. Manual search was also conducted.Study Selection and Data Extraction:Observational and interventional longitudinal studies evaluating ERT and SRT for GD were included. Single mean meta-analyses were conducted for each drug using R.Data Synthesis:The initial search retrieved 2246 articles after duplicates were removed. Following screening and eligibility assessment, 68 reports were included. The studies evaluated imiglucerase, velaglucerase alfa, taliglucerase alfa, miglustat, and eliglustat. The results showed that ERT is effective as a treatment in both naïve and experienced patients. Miglustat did not significantly improve blood outcomes in naïve patients and resulted in a decrease in the platelet levels of experienced patients. Eliglustat was mainly assessed for experienced patients and resulted in stable outcome values.Relevance to Patient Care and Clinical Practice:This extensive SR confirms the effectiveness of GD treatments in short- and long-term follow-ups.Conclusions:The results were favorable for all ERTs and for eliglustat. Based on the assessed evidence, miglustat did not achieved expressive results. However, all evidence should be interpreted considering its limitations and does not replace well-conducted randomized trials.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-11T07:53:14Z
      DOI: 10.1177/10600280221108443
       
  • Postoperative Application of Dexmedetomidine is the Optimal Strategy to
           Reduce the Incidence of Postoperative Delirium After Cardiac Surgery: A
           Network Meta-Analysis of Randomized Controlled Trials

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      Authors: Limei Shang, Ming Hou, Fengying Guo
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Previous pairwise meta-analyses demonstrated the efficacy and safety of dexmedetomidine in preventing postoperative delirium (POD) after cardiac surgery; however, the optimal time of applying dexmedetomidine remains unclear.Objective:This network meta-analysis aimed to determine the optimal time of using dexmedetomidine to reduce the incidence of POD following cardiac surgery.Methods:We first retrieved eligible randomized controlled trials (RCTs) from previous meta-analyses, and then an updated search was performed to identify additional RCTs in PubMed, Embase, and the Cochrane library from January 1, 2021 to October 31, 2021. Two authors screened literature, collected data, and evaluated bias risk of eligible studies. Finally, we performed Bayesian network analysis using R version 3.6.1 with the “gemtc” and “rjags” package.Results:Eighteen studies with 2636 patients were included, and all studies were identified from previous meta-analyses. Results showed that postoperative dexmedetomidine reduced the risk of POD compared with normal saline (NS) (odds ratio [OR], 0.13; 95% credible interval [CrI], 0.03-0.35) and propofol (PRO) (OR, 0.19; 95%CrI, 0.04-0.66). Postoperative dexmedetomidine was associated with a lower incidence of POD compared with perioperative dexmedetomidine (OR, 0.21; 95% CrI, 0.04-0.82). Moreover, postoperative dexmedetomidine had the highest probability of ranking best (90.98%), followed by intraoperative dexmedetomidine (46.83%), PRO (36.94%), perioperative dexmedetomidine (30.85%), and NS (60.02%).Conclusion and Relevance:Dexmedetomidine reduces the incidence of POD compared with PRO and NS in patients undergoing cardiac surgery, and postoperative application of dexmedetomidine is the optimal time.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-09T10:20:34Z
      DOI: 10.1177/10600280221106622
       
  • Adherence to Sedation Targets With Weight-Based Propofol and
           Dexmedetomidine in Patients With Morbid Obesity

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      Authors: Emily Hayes, Alyson Esteves
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Propofol and dexmedetomidine are routinely used in intensive care units (ICUs). Both are lipophilic, potentially leading to accumulation in adipose tissue. Limited evidence exists on what body weight to utilize in patients with morbid obesity.Objective:The purpose of this research was to evaluate the safety and efficacy of weight-based sedation with propofol and dexmedetomidine in ICU patients with morbid obesity.Methods:Retrospective review of ICU patients admitted from January 2018 to January 2020 who were sedated for ≥48 hours was performed. The primary outcome was the percentage of time within target sedation during the first 48 hours, stratified by body mass index (BMI)
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-02T05:03:52Z
      DOI: 10.1177/10600280221108429
       
  • The Effects of Adding Semaglutide to High Daily Dose Insulin Regimens in
           Patients With Type 2 Diabetes

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      Authors: Jodi Meyer, Emma Dreischmeier, Molly Lehmann, Jessica Phelan
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Escalating doses of insulin required with progression of type 2 diabetes may lead to weight gain. Weight loss associated with semaglutide may be beneficial. However, data on the use of semaglutide in patients requiring high daily doses of insulin are currently lacking.Objective:The purpose of this project was to evaluate the impact of semaglutide on total daily dose (TDD) of insulin when initiated in patients with type 2 diabetes mellitus (T2DM) on high daily doses of insulin. Secondary objectives assessed included changes in weight, body mass index (BMI), blood pressure, heart rate, and diabetes and blood pressure medications.Methods:This IRB exempt retrospective medical record review included patients with T2DM prescribed semaglutide and at least 100 units TDD of insulin between January 1, 2019, and December 31, 2019.Results:Of the 72 patients included, the TDD of insulin decreased from baseline to 6 months (183 ± 98 units and 143 ± 99 units, P < 0.001). Average A1c and body weight also decreased from baseline to 6 months (8.9% ± 1.3% and 7.6% ± 1.5%, P < 0.001 and 123.9 ± 23.5 kg and 118.9 ± 22.9 kg, P < 0.001, respectively). Limitations included a homogenous patient population and inability to control confounding factors.Conclusion and Relevance:Improvement in glycemic control occurred despite reductions in TDD of insulin. Improvements in A1c and body weight were clinically significant. This analysis adds to existing literature supporting the use of GLP-1 RAs in patients on high daily doses of insulin.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-02T05:00:12Z
      DOI: 10.1177/10600280221107381
       
  • Cabotegravir: The First Long-Acting Injectable for HIV Preexposure
           Prophylaxis

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      Authors: Spencer H. Durham, Ashlee Milam, Dylan Waer, Elias B. Chahine
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveReview the pharmacology, pharmacokinetics, efficacy, safety, and role of long-acting injectable cabotegravir (CAB-LA) in HIV preexposure prophylaxis (PrEP).Data SourcesA literature search was performed using PubMed and Google Scholar (2012 to April 2022) with the search terms cabotegravir, preexposure prophylaxis, and PrEP. Other resources included abstracts presented at recent conferences, the manufacturer’s Web site, prescribing information, and review articles.Study Selection and Data ExtractionAll English-language articles of studies assessing the efficacy and safety of CAB-LA for PrEP were included.Data SynthesisCAB-LA is the first long-acting injectable therapy approved for HIV-1 PrEP in both men and women. It is a suspension given intramuscularly every other month. CAB-LA has been shown to be more effective than daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in preventing HIV-1 infection among high-risk individuals. Two phase 3 trials were stopped early on the basis of superior efficacy of CAB-LA. The most common adverse effects were injection site reactions (ISRs), although they tended to decrease over time, and few participants in clinical trials discontinued use due to ISRs.Relevance to Patient Care and Clinical PracticeCAB-LA may be particularly useful for individuals with known adherence problems to oral therapy, those with renal impairment, and those with decreased bone mineral density. However, CAB-LA is more expensive than generic TDF/FTC and may be associated with weight gain.ConclusionsCAB-LA is the first long-acting injectable agent for HIV PrEP. It is more effective than oral TDF/FTC, is well-tolerated aside from ISRs, and has few clinically significant drug-drug interactions.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-02T04:57:13Z
      DOI: 10.1177/10600280221102532
       
  • Inclisiran: A First-in-Class siRNA Therapy for Lowering Low-Density
           Lipoprotein Cholesterol

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      Authors: Essie Samuel, Maya Watford, Ugochukwu O. Egolum, David N. Ombengi, Hua Ling, Drew W. Cates
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review the current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of inclisiran in lowering lipid levels.Data Sources:A PubMed (from December 1, 2014 to April 15, 2022) and ClinicalTrials.gov search was conducted using ALN-PCSsc, ALN-60212, PCSK9si KJX-839, and inclisiran. Additional articles were identified by hand from references.Study Selection and Data Extraction:We included English-language articles evaluating inclisiran pharmacology, efficacy, or safety in humans for lowering low-density lipoprotein cholesterol (LDL-C).Data Synthesis:Inclisiran is a novel small interfering RNA-based therapy administered as a twice-yearly subcutaneous injection. By binding to the messenger RNA (mRNA) precursor of proprotein convertase subtilisin/kexin type 9 (PCSK9), inclisiran inhibits expression of the PCSK9 gene, resulting in increased recycling and expression of LDL receptors and decreased levels of LDL-C. Like PCSK9 inhibitors, inclisiran was associated with a comparable extent of LDL-C reduction in several phase II/III trials. Compared with placebo, inclisiran was found to have similar adverse events except for injection-site reaction.Relevance to Patient Care and Clinical Practice:Currently, inclisiran lacks data on clinical outcome improvement or long-term safety. However, it may play a role in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalent if optimal LDL-C cannot be achieved by statins and PCSK9 inhibitors cannot be tolerated. The drug may be used for heterozygous familial hypercholesterolemia.Conclusion:Inclisiran is an effective and safe medication for lowering LDL-C levels. Additional data regarding efficacy on cardiovascular outcomes and long-term safety profile with inclisiran are needed.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-07-01T06:44:38Z
      DOI: 10.1177/10600280221105169
       
  • Use of Fluoroquinolones or Sulfamethoxazole-Trimethoprim Compared to
           Β-Lactams for Oral Step-Down Therapy in Hospitalized Patients With
           Uncomplicated Enterobacterales Bacteremia

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      Authors: Tyler Mack, Jon J. Hiles, Justin Wrin, Armisha Desai
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundAntibiotic therapy for uncomplicated Enterobacterales bacteremia from a urinary source has traditionally consisted of fluoroquinolones (FQs) and sulfamethoxazole-trimethoprim (SXT). However, adverse events associated with FQs and emerging antimicrobial resistance have led to alternative agents, specifically oral Β-lactams (OBLs), being utilized despite concern of subtherapeutic serum concentrations related to their low relative bioavailability.ObjectiveTo compare efficacy of antibiotic therapies with bioavailability differences in patients with uncomplicated bacteremia from a urinary source.MethodsThis was a retrospective study comparing clinical efficacy in hospitalized adult patients receiving OBL or FQ/SXT. Patients were required to receive at least 48 hours of appropriate intravenous antibiotic therapy and at least one dose of oral therapy. The primary outcome was all-cause hospital readmission within 30 days of discharge. Secondary outcomes included readmission with recurrent infectious etiology and readmission due to Clostridioides difficile infection.ResultsOf 210 eligible patients, 91 received FQ/SXT and 119 received OBL. There was no difference between the groups in all-cause hospital readmission (FQ/SXT: 16.5%; OBL: 14.3%) (P = 0.660 [95% confidence interval, CI = −0.076, 0.120]) or readmission with recurrent bacteremia (FQ/SXT: 0%; OBL: 3.4%) (P = 0.135). There was a significant difference in repeat hospital admission with recurrent urinary tract infection (UTI) (FQ/SXT: 0%, OBL: 5.0%) (P = 0.037).Conclusion and RelevanceOBLs appear to be non-inferior to FQ/SXT in the rate of all-cause hospital readmission within 30 days. However, OBLs may be associated with increased readmissions with recurrent UTI.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-25T09:35:58Z
      DOI: 10.1177/10600280221106789
       
  • Enhancing the Drug Library to Improve Infusion Pump Safety and Usability

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      Authors: Sondra Davis, Andrew Thompson
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-25T09:31:30Z
      DOI: 10.1177/10600280221103562
       
  • Review of Tralokinumab in the Treatment of Atopic Dermatitis

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      Authors: Rohan Singh, Alexandra Taylor, Milaan A. Shah, Lindsay C. Strowd, Steven R. Feldman
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo review pharmacokinetics, efficacy, and safety of tralokinumab in treatment of atopic dermatitis (AD).Data SourcesLiterature review was conducted using MEDLINE (PubMed), EMBASE, and ClinicalTrials.gov for articles published between January 2010 and May 2022.Study selection and data extractionArticles in English discussing tralokinumab in AD were included.Data synthesisIn one phase 2 trial, more subjects treated with tralokinumab 150 and 300 mg achieved an Investigator’s Global Assessment (IGA) of 0/1 with minimum ≥2 point IGA reduction (23%), versus placebo (11.8%, P = 0.10). During 2 phase 3 trials, more subjects treated with tralokinumab achieved IGA success (ECZTRA 1: 15.8% and ECZTRA 2: 22.2%), versus placebo (7.1% and 10.9%, respectively; P = 0.002 and P < 0.001). During one phase 3 trial, in conjunction with topical corticosteroids (TCS), more subjects treated with tralokinumab 300 mg achieved IGA success (ECZTRA 3: 38.9%), versus placebo (26.2%, P = 0.015). During another phase 3 trial in subjects with resistance or contraindication to oral cyclosporine, more subjects treated with tralokinumab 300 mg achieved an Eczema Area Severity Index 75 (64.2%), versus placebo (50.5%, P = 0.018).Relevance to patient care and clinical practiceTralokinumab is efficacious for moderate-to-severe AD, as monotherapy, in conjunction with TCS, and resistance or contraindication to cyclosporine. Although IL-4 and IL-13 are both implicated in AD’s pathogenesis, IL-13 is overexpressed, and head-to-head trials are needed to assess efficacy of tralokinumab, versus dupilumab. Compared with upadacitinib and abrocitinib, tralokinumab is not associated with black-box warnings.ConclusionsTralokinumab is an efficacious and safe systemic treatment for moderate-to-severe AD.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-22T09:16:24Z
      DOI: 10.1177/10600280221105686
       
  • Review of Calcipotriene and Betamethasone Dipropionate Cream in the
           Treatment of Psoriasis

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      Authors: Alexandra Taylor, Rohan Singh, Steven R. Feldman
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo review the pharmacokinetics, efficacy, and safety of recently approved calcipotriene and betamethasone dipropionate (C-BD) cream.Data sourcesA literature review was conducted using MEDLINE (PubMed) and ClinicalTrials.gov from 2002 to mid-May 2022.Study selection and data extractionArticles in English discussing the use of C-BD cream in the treatment of psoriasis were included.Data synthesisIn 2 phase I trials, there was no phototoxic or photoallergic skin reaction at irradiated C-BD cream sites at baseline, 24 hours, 48 hours, and 72 hours postirradiation. In 2 phase III trials, after 8 weeks of treatment, more subjects treated with C-BD cream achieved Physician’s Global Assessment treatment success (37.4%), compared to C-BD topical suspension (TS) (22.8%, P < 0.0001) and vehicle (3.7%, P < 0.0001). More subjects had greater mean percentage decline in Modified Psoriasis Area Severity Index (Trial 1: 52.9% and Trial 2: 64.6%), when compared to C-BD TS (Trial 1: 51.3%, P < 0.0001 and Trial 2: 56.4%, P < 0.0001) and vehicle (Trial 1: 22.9%, P < 0.0001 and Trial 2: 20.0%, P < 0.0001).Relevance to patient care and clinical practicePsoriasis has a multifactorial pathogenesis and topical treatments are considered first line. Poor adherence is a major hurdle in management; the combination of 2 separate first-line drugs may address this by decreasing the complexity of treatment regimens. A cream formulation can be preferred, and C-BD is now Food and Drug Administration (FDA) approved as one.ConclusionsNewly FDA-approved C-BD cream with novel polyaphron dispersion (PAD) technology provides a safe efficacious combination therapy for mild-to-moderate psoriasis which may be preferred by some patients.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-22T07:29:06Z
      DOI: 10.1177/10600280221105508
       
  • Vasopressin-Induced Hyponatremia in Infants Following Cardiovascular
           Surgery

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      Authors: Caitlyn V. Bradford, Jamie L. Miller, Courtney D. Ranallo, Stephen B. Neely, Peter N. Johnson
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundVasopressin is increasingly used in infants following cardiac surgery. Hyponatremia is a noted adverse event, but incidence and risk factors remain undefined.ObjectiveThe primary objective was to identify the incidence of vasopressin-induced hyponatremia. Secondary objectives included comparing baseline and change in serum sodium concentrations between infants receiving vasopressin with and without hyponatremia, and comparing vasopressin dose, duration, and clinical characteristics in those with and without hyponatremia.MethodsThis Institutional Review Board–approved, retrospective case-control study included infants
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-17T08:56:50Z
      DOI: 10.1177/10600280221103576
       
  • Correlation Between and Nursing Satisfaction With CIWA-Ar, mMINDS, and
           SEWS Scoring Tools for the Assessment of Severe Alcohol Withdrawal
           Syndrome in ICU Patients

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      Authors: Mary Bradley, Tyree H. Kiser, Scott W. Mueller, Paul M. Reynolds, Robert MacLaren
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundManagement of alcohol withdrawal syndrome (AWS) requires bedside assessments of symptom severity to guide therapies. Commonly used assessment tools are the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar), the modified Minnesota Detoxification Scale (mMINDS) and the Severity of Ethanol Withdrawal Scale (SEWS).ObjectiveTo determine strength of correlation between the CIWA-Ar, mMINDS, and SEWS for bedside assessment of severe AWS and to survey nurses regarding ease of use of each tool.MethodsA single-center prospective correlation study of the three assessment tools performed by bedside nurses on patients with AWS followed by a questionnaire assessing ease of use of each tool (1 being the easiest and 9 being the hardest).ResultsA total of 66 correlation assessments were performed by 49 nurses in 21 patients with AWS. Bedside CIWA-Ar, mMINDS, and SEWS were 14 ± 8.3, 13.9 ± 6.5, and 10.1 ± 4.5, respectively. The Pearson correlation coefficients were 0.814 (95% CI, 0.714-0.881) between CIWA-Ar and mMINDS; 0.722 (95% CI, 0.585-0.820) between CIWA-Ar and SEWS; and 0.658 (95% CI, 0.498-0.775) between SEWS and mMINDS. Nurse ratings for ease of use were 4 ± 2.3 for CIWA-Ar, 2.9 ± 2 for mMINDS (p=0.0044 vs. CIWA-Ar), and 4.8 ± 2.1 for SEWS (p=0.036 vs. CIWA-Ar, p
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-17T08:54:36Z
      DOI: 10.1177/10600280221102562
       
  • Simplification and Multidimensional Adaptation of the Stratification Tool
           for Pharmaceutical Care in People Living With HIV

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      Authors: Ramón Morillo-Verdugo, Tamara Aguilar Pérez, Mercedes Gimeno-Gracia, Carmen Rodríguez-González, María de las Aguas Robustillo-Cortes
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundPeople living with human immunodeficiency virus (HIV) require specific pharmaceutical care (PC). Although the 2017 Capacity-Motivation-Opportunity (CMO) PC model allows a multidisciplinary approach that focuses on patient needs, it is too complex and presents room for improvement.ObjectiveThe aim of this study is to simplify and adapt the previous 2017 PC tool through a multidimensional approach to improve HIV patient care, to prove the validity of the model in real-life patients.MethodsThe new PC tool was generated by keeping some of the variables of the 2017 document and conducting a literature search. Content validity was determined by a 2-round Delphi methodology with an expert panel of 42 pharmacists. Consensus for the first and second rounds was defined as ≥70% agreement. The tool generated was validated in 407 real-life patients.ResultsThirty-seven experts completed the first round of the Delphi survey and 36 the second. No consensus was reached for 3 variables, any of the frequency options and 4 interventions, while the experts agreed not to include 1 intervention in round 1. Consensus to include them was found for all but 1 variable and 1 intervention in round 2. The final tool obtained to select and stratify HIV-positive patients was composed of 9 dimensions divided into 17 variables. The new tool was validated with real-life patients and 3 priority levels were defined.Conclusions and relevanceWe created a new pyramid of score thresholds to classify patients into priority levels. The new tool simplifies the 2017 model and improves its utility to help HIV-positive patients, owing to its multidimensional approach.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-16T06:56:48Z
      DOI: 10.1177/10600280221096759
       
  • A Systematic Review of Warfarin Use in Post-Bariatric Surgery Patients:
           Cases Compiled From a Literature Review

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      Authors: Pooja H. Patel, Tiffany Ho, Shreeya M. Upadhyay
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveThe objective of this review was to provide dosing recommendations for percentage change in weekly warfarin dose and rates of thrombotic and bleeding events in patients requiring long-term warfarin therapy after bariatric surgery.Data Sources:A comprehensive literature search of PubMed (through April 5, 2021), Cochrane Library, and Google Scholar (through April 5, 2021) databases was completed using the keywords warfarin OR vitamin k antagonist AND bariatric surgery.Study selection and data extraction:Retrospective studies and matched-cohort studies evaluating preoperative and postoperative use of warfarin after bariatric surgery for obesity were considered. Weekly dose defined as sum of daily doses of warfarin for 7 consecutive days was a required outcome to be considered in this review. Patients were excluded from review if post-operative dosage change was not reported.Data synthesisSix studies were included with a total of 160 patients who met the criteria. A decrease in average warfarin dose was seen in all studies, with the largest decrease occurring at 1 month postsurgery followed by an upward trend toward baseline about 90 days postsurgery. While thrombotic events were observed in none of the patients, there was an increased risk of bleeding in patients, particularly in those who underwent roux-en-y gastric bypass (RYGB) surgery.Relevance to patient care and clinical practiceThe study provides a specific warfarin dosing titration regimen, as well as embolic and bleed risk in post-bariatric surgery population.ConclusionsClinicians may consider lowering warfarin weekly dose by about 25% immediately postsurgery, with doses approaching closer to baseline about 90 days postsurgery.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-14T01:31:21Z
      DOI: 10.1177/10600280221105312
       
  • The Impact of a Diabetes Transitions of Care Clinic on Hospital
           Utilization and Patient Care

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      Authors: Alyssa Rinaldi, Melissa Snider, Amy James, Cara Harris, Kelly Cephas Hill, Junan Li, Kathleen Wyne
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundThere is currently limited guidance from the American Diabetes Association regarding transitions of care for patients with diabetes.ObjectiveThis study’s aim was to determine the impact of a diabetes-specific transitions of care clinic (TOCC) on hospital utilization and patient outcomes in recently discharged patients with diabetes.MethodsThis retrospective study evaluated patients seen by TOCC as compared with similar patients discharged from the study institution the year prior. The primary outcome was a composite of the number of unique patients with readmissions/emergency department (ED) visits within 30 days of discharge. Secondary outcomes included a subcomponent analysis of readmissions/ED visits, index hospital length of stay (LOS), and to describe clinical interventions made in clinic. This study was approved by the institutional review board of the Office of Responsible Research Practice at the Ohio State University Wexner Medical Center.ResultsThere were 165 patients in the TOCC group and 157 in the control group based on the matching criteria. There was a statistically significant decrease in the primary outcome in the TOCC group versus the control group (18% vs 36%, P < 0.001). In evaluation of its subcomponents, there was a statically significant decrease in patients with readmissions (11% vs 26%, P < 0.001) but not ED visits (10% vs 17%, P = 0.096). The LOS for the TOCC group was shorter at 4 days versus 5 days in the control group (P = 0.055).Conclusions and RelevanceThe implementation of a diabetes-specific TOCC can decrease both readmissions and ED visits and may impact hospital LOS. In addition, a TOCC can be used to identify gaps in preventive care. The results from this study may help support the creation of similar TOCC at other institutions.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-10T05:37:23Z
      DOI: 10.1177/10600280221102557
       
  • Comparison of Standard-Dose Versus High-Dose Dexmedetomidine in
           Extracorporeal Membrane Oxygenation

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      Authors: Erika L. Zarfoss, Jeffrey Garavaglia, J. W. Awori Hayanga, Galen Kabulski
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundDexmedetomidine is commonly used to achieve light sedation in patients on extracorporeal membrane oxygenation (ECMO) despite minimal evidence. In vivo studies have shown dexmedetomidine sequestration in ECMO circuits, and higher doses may be used to overcome sequestration.ObjectiveThe purpose of this study was to compare safety and efficacy of dexmedetomidine at standard versus high doses in ECMOMethodsA retrospective analysis of adult ECMO patients was performed. Patients were compared as receiving either standard-dose (≤1.5 µg/kg/h) or high-dose (>1.5 µg/kg/h) dexmedetomidine. Safety outcomes included new onset bradycardia or hypotension. Efficacy was compared by the addition of concomitant sedative and analgesic agents.ResultsOne hundred five patients were evaluated, with 20% of patients in the high-dose group. Comparing standard and high dosing, no significant differences were seen in primary safety outcomes including bradycardia (49% vs 38%, P = 0.46), hypotension (79% vs 71%, P = 0.56), or addition of vasopressors (75% vs 71%, P = 0.78). Need for concomitant analgesic agents and propofol was similar between groups.Conclusion and RelevanceThis represents the first evaluation of use of high-dose dexmedetomidine in ECMO. Rates of dexmedetomidine higher than 1.5 µg/kg/h were commonly used in patients on ECMO, with similar rates of adverse effects and need for concomitant propofol and analgesic agents. While high-dose dexmedetomidine may be as safe as standard dose, no additional efficacy was found.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-09T01:44:00Z
      DOI: 10.1177/10600280221102474
       
  • Review of Ruxolitinib in the Treatment of Atopic Dermatitis

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      Authors: Lindsey A Mohney, Rohan Singh, Steven R. Feldman
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo review the pharmacokinetics, efficacy, and safety of a newly approved topical Janus kinase 1 (JAK) inhibitor, ruxolitinib (RUX), in patients with atopic dermatitis (AD).Data SourcesA literature search was completed May 1, 2022. The term RUX and AD was queried in MEDLINE (PubMed) and EMBASE databases.Study Selection and Data ExtractionPeer-reviewed articles written in English and published prior to May 1, 2022 were included.Data SynthesisIn the phase II clinical trial, more patients treated with 1.5% topical RUX twice a day had a mean percentage improvement in Eczema Area and Severity Index (EASI) scores from baseline to 4 weeks, when compared to vehicle (71.6% vs 15.5%; P < 0.001). In phase III clinical trials, greater percentage of patients who received 0.75% topical RUX (TRuE-AD1 50.0% and TRuE-AD2 39.0%) or 1.5% topical RUX (TRuE-AD1 53.8% and TRuE-AD2 51.3%) achieved an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and had a ≥2-grade improvement from baseline to 8 weeks, when compared to vehicle (TRuE-AD1 15.1% and TRuE-AD2 7.6%; P < 0.001).Relevance to Patient Care and Clinical PracticeAtopic dermatitis is a highly prevalent long-term inflammatory skin condition. Pruritus is the main contributor of decreased quality of life in patients with AD. Topical RUX inhibits JAK1 and JAK2 producing antiinflammatory and antipruritic effects. Patients experienced a reduction in pruritus within 2 days. This decreased pruritus translated to increased quality of life and less sleep disturbances.ConclusionData from phase II and III clinical trials in adult patients suggest RUX is an effective and safe therapy for AD.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-08T12:33:18Z
      DOI: 10.1177/10600280221103282
       
  • Lack of Access to Rifaximin Upon Hospital Discharge Is Frequent and
           Results in Increased Hospitalizations for Hepatic Encephalopathy

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      Authors: Ann Marie Stoll, Maria Guido, Alicia Pence, Anthony J. Gentene
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundHepatic encephalopathy (HE) is a complication of cirrhosis. Rifaximin, added to lactulose, effectively maintains remission and reduces hospitalizations from HE compared with lactulose alone. Although the clinical evidence supports the use of rifaximin, concerns remain regarding the financial implications and subsequent impact on medication access and outcomes.ObjectiveThe goal of this study was to determine whether medication access to rifaximin at hospital discharge reduces readmission and office visits related to HE.MethodsA retrospective study was conducted in compliance with local institutional review board including cirrhotic patients discharged with a rifaximin prescription for HE. Patients were stratified into 2 groups: those able to obtain rifaximin and those unable to obtain rifaximin upon discharge. The primary outcome was to evaluate the rate of HE recurrence in each group as defined as a composite of readmission or office visit for acute HE within 12 months of discharge.ResultsAccess to rifaximin significantly reduced the risk of hospital admission and office visit for acute HE over 12 months. A hospitalization or office visit occurred in 24.5% of patients in the medication access group compared with 50% in the group without medication access. Only 58% of patients had access to rifaximin at discharge.Conclusion and RelevanceRifaximin use was associated with significantly reduced risk of hospitalization and office visits for HE. At discharge, 42% of patients did not have access to rifaximin regardless of being prescribed the medication, identifying that copay is a significant barrier in allowing patients to have access to rifaximin.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-06T06:09:26Z
      DOI: 10.1177/10600280221100537
       
  • Evaluation of the Addition of Angiotensin II in Patients With Shock After
           Cardiac Surgery at a Veterans Affairs Medical Center

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      Authors: Stephanie Bird, Mastian Chand, Trung Ly Tran, Shahid Ali, Samir S. Awad, Lorraine D. Cornwell, Alexander Schutz, Ernesto Jimenez
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Vasoplegic shock occurs in up to 37% of cardiac surgery patients. We investigated the use of angiotensin II for treating vasoplegic shock in these patients.Objectives:We assessed clinical outcomes and mortality in patients undergoing cardiac surgery at our center between March 1, 2018 and October 31, 2020 who developed vasoplegic shock, comparing those who received angiotensin II with those who did not.Methods:This was a retrospective chart review. Response to angiotensin II was defined as increase in or maintenance of mean arterial pressure (MAP) and decrease in background vasopressor dosage.Results:Angiotensin II was administered to 7 patients (postoperatively in 4 patients [57.1%]) with vasoplegic shock and baseline norepinephrine equivalent (NEE) of 0.49 ± 0.08 μg/kg/min; 12 patients with vasoplegic shock did not receive angiotensin II. Within 3 hours of angiotensin II administration, NEE decreased by 38.0 ± 33.1%. Angiotensin patients were more likely to newly require renal replacement therapy (66.7% vs 9.1%, P = 0.03) and had a longer, although not statistically significant, postoperative stay (23.1 vs 14.0 days, P = 0.16). Despite higher NEE requirements at baseline (0.49 vs 0.30, P = 0.03) and over the next 48 hours in the angiotensin group, no between-group differences in 7-day mortality (14.3% vs 0.0%, P = 0.37) or 30-day mortality (28.6% vs 8.3%, P = 0.52) were noted.Conclusion and Relevance:In patients who developed vasoplegic shock after cardiac surgery, angiotensin II administration allowed immediate dosage reductions of other vasopressors while maintaining MAP. Despite its small sample size, this study adds to the paucity of data in these patients and highlights future research needs.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-06T06:01:17Z
      DOI: 10.1177/10600280221099928
       
  • Evaluation of Opportunities for Oral Antibiotic Therapy in Bone and Joint
           Infections

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      Authors: Hita Bhagat, Monica K. Sikka, Ellie S. Sukerman, Jina Makadia, James S. Lewis, Amber C. Streifel
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:The OVIVA trial suggests oral antibiotics are an alternative to intravenous antibiotics to treat bone and joint infections (BJI). A shift in practice to treatment with oral antibiotics would eliminate the need for central vascular access, improve patient satisfaction, and reduce overall healthcare costs.Objective:The primary objective was to identify the proportion of patients treated for BJIs with outpatient parenteral antimicrobial therapy (OPAT) who would have qualified for oral antibiotics based on microbiological data. The secondary objective was to conduct a cost-analysis to estimate potential cost-savings had eligible patients been treated with oral antibiotics.Methods:This was a single-center, retrospective study of adult patients in the United States treated with intravenous antibiotics for BJIs from January 2018 to April 2020. Inclusion and exclusion criteria matched the OVIVA trial. Patients with Staphylococcus aureus bacteremia, endocarditis, or other high-risk features were excluded.Results:281 patients met the inclusion criteria. Most had prosthetic joint infections (56%). Infections caused by coagulase-negative staphylococci (25%) were most common, followed by S. aureus (23%) and polymicrobial infections (22%). 69 (25%) patients required a switch during their OPAT course to an alternate antibiotic agent. Thirteen patients (5%) experienced vascular access complications, and 6 patients (2%) developed Clostridiodes difficile infections. Oral therapy could have resulted in an estimated average savings per patient of $3,270.69 USD.Conclusion and Relevance:Most patients treated with OPAT for BJIs were candidates for oral antibiotics. A change in practice would result in cost-savings to the U.S. healthcare system.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-03T09:21:23Z
      DOI: 10.1177/10600280221101105
       
  • Management of Steroid-Refractory Gastrointestinal Immune-Related Adverse
           Events

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      Authors: Samantha Brongiel, Kristen L. Rychalsky, Darren Luon, Aubrey R. Johnson, Christina Price, Osama Abdelghany
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Immune checkpoint inhibitors (ICIs) cause inflammatory immune-related adverse events (irAEs), which are often effectively managed with steroids. Less is known about the best management of irAEs refractory to steroid treatment.Objective:We aimed to assess the efficacy of second-line medications used to treat gastrointestinal (GI) irAEs.Methods:This study was a single-center, retrospective medical record review of patients who received steroids for an ICI GI irAE and at least one dose of infliximab, vedolizumab, or adalimumab for irAE treatment from March 25, 2011 to September 20, 2019, approved by Yale University’s Institutional Review Board. Our primary objective was to assess the efficacy of second-line treatment, measured by the change in the Common Terminology Criteria for Adverse Events Version 5.0 grading system.Results:A total of 39 patients met inclusion criteria. Treatment for steroid-refractory GI irAEs demonstrated a high response rate, with irAE resolution seen in 89.7% of patients. Patients who were specifically initiated on infliximab within 14 days of starting steroids had a higher percent resolution seen in 94.4% of patients. The average time to response, defined as the average days from second-line therapy to reported symptom resolution, was 17 days.Conclusion and relevance:Steroid-refractory GI irAEs can be managed effectively in most patients with immunosuppressive therapy, such as infliximab. Furthermore, initiating second-line immunosuppressive therapy within 14 days of steroid failure resulted in a higher rate of symptom resolution.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-03T09:19:02Z
      DOI: 10.1177/10600280221094330
       
  • Omadacycline and Clostridioides difficile: A Systematic Review of
           Preclinical and Clinical Evidence

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      Authors: Kevin W. Garey, Warren Rose, Kyle Gunter, Alisa W. Serio, Mark H. Wilcox
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveThe objective of this systematic review is to summarize in vitro, preclinical, and human data related to omadacycline and Clostridioides difficile infection (CDI).Data SourcesPubMed and Google Scholar were searched for “omadacycline” AND (“Clostridium difficile” OR “C difficile” OR “Clostridioides difficile”) for any studies published before February 15, 2022. The US Food and Drug Administration (FDA) Adverse Events Reporting System (AERS) was searched for omadacycline (for reports including “C. difficile” or “CDI” or “gastrointestinal infection”). The publications list publicly available at Paratek Pharmaceuticals, Inc. Web site was reviewed.Study Selection and Data ExtractionPublications presenting primary data on omadacycline and C. difficile published in English were included.Data SynthesisPreclinical and clinical evidence was extracted from 14 studies. No case reports in indexed literature and no reports on FDA AERS were found. Omadacycline has potent in vitro activity against many C. difficile clinical strains and diverse ribotypes. In phase 3 studies, there were no reports of CDI in patients who received omadacycline for either community-acquired bacterial pneumonia or acute bacterial skin and skin structure infection.Relevance to Patient Care and Clinical PracticeOmadacycline should be considered a low-risk antibiotic regarding its propensity to cause CDI.ConclusionsReducing the burden of CDI on patients and the health care system should be a priority. Patients with appropriate indications who are at heightened risk of CDI may be suitable candidates for omadacycline therapy. In these patients, omadacycline may be preferable to antibiotics with a high CDI risk.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-03T09:08:22Z
      DOI: 10.1177/10600280221089007
       
  • Targeting EGFR Exon 20 Insertion Mutation in Non–small cell Lung Cancer:
           Amivantamab and Mobocertinib

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      Authors: Molly C. Russell, Alyssa M. Garelli, David J. Reeves
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo evaluate clinical data regarding the use of amivantamab and mobocertinib for epidermal growth factor receptor (EGFR) exon 20 insertion mutation non–small cell lung cancer (NSCLC) and assess their potential impact on the care of patients.Data SourcesA comprehensive literature search of PubMed and Clinicaltrials.gov was conducted using the terms amivantamab, Rybrevant, JNJ-61186372, mobocertinib, Exkivity, TAK-788.Study Selection and Data ExtractionRelevant English-language clinical trials were evaluated.Data SynthesisAmivantamab and mobocertinib were Food and Drug Administration (FDA) approved based on phases 1 and 2 studies. Amivantamab demonstrated an overall response rate (ORR) of 40% and median progression-free survival (PFS) of 8.3 months. Patients commonly experienced rash (86%), paronychia (45%), and stomatitis (21%). Mobocertinib demonstrated an ORR of 28% and median PFS of 7.3 months in phase 1/2 study. Patients frequently experienced diarrhea (91%), rash (45%), and paronychia (38%). Cardiac monitoring is recommended with mobocertinib due to risk of QTc prolongation and cardiac failure.Relevance to Patient CareFor NSCLC patients who possess an EGFR exon 20 insertion mutation, amivantamab and mobocertinib are indicated as second-line therapy. Ongoing studies are evaluating these therapies as first-line monotherapy and as part of combination regimens in multiple cancer types. Dosage forms, drug interactions, and patient comorbidities should be considered when deciding which of the 2 agents may be most appropriate.ConclusionAmivantamab and mobocertinib target an uncommon NSCLC mutation that has historically marked a poor prognosis because of innate resistance to previously approved EGFR tyrosine kinase inhibitors. Promising results from early phase trials supported accelerated FDA approval.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-02T01:33:52Z
      DOI: 10.1177/10600280221098398
       
  • The Use of High-Dose Corticosteroids Versus Low-Dose Corticosteroids With
           and Without Tocilizumab in COVID-19 Acute Respiratory Distress Syndrome

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      Authors: Alyson Katz, Diana Altshuler, John Papadopoulos, Nancy Amoroso, Ronald Goldenberg, Elizabeth Tarras, Kelsey Krolikowski, Jacklyn Hagedorn, David Fridman, Xian Jie Cindy Chen, Eduardo Iturrate, Shari B. Brosnahan
      First page: 5
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Corticosteroids and tocilizumab have been shown to improve survival in patients who require supplemental oxygen from coronavirus disease 2019 (COVID-19) pneumonia. The optimal dose of immunosuppression for the treatment of COVID-19 acute respiratory distress syndrome (ARDS) is still unknown.Objective:The objective of this study was to evaluate the effectiveness and safety of high- versus low-dose corticosteroids with or without tocilizumab for the treatment of COVID-19 ARDS.Methods:This was a retrospective study of patients admitted to the intensive care unit (ICU) requiring mechanical ventilation who received high- versus low-dose corticosteroids with or without tocilizumab. The primary outcome was survival to discharge. Safety outcomes included infections and incidence of hyperglycemia.Results:In this cohort, 110 (54%) and 95 (46%) patients received high-dose (≥10 mg dexamethasone equivalent) and low-dose (
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-20T04:29:28Z
      DOI: 10.1177/10600280221094571
       
  • The Risk for Prostate Cancer With Calcium Channel Blockers: A Systematic
           Review, Meta-Analysis, and Meta-Regression

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      Authors: Victoria Rotshild, Natalie Rabkin, Ilan Matok
      First page: 16
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundFor decades, conflicting results were published regarding the increased risk of Prostate cancer (PCa) among calcium channel blocker (CCB) users.ObjectiveWe aimed to evaluate the association between PCa and CCB exposure and assess moderating factors.MethodsWe performed a systematic literature search in PubMed, Embase, and Cochrane databases for observational and randomized studies published until November 2020 with no language limitations, including data on the risk for PCa in CCB users compared with non-CCB users. We applied a random-effects model meta-analysis to pool results. In addition, we investigated potential moderating factors, such as CCB type, study type, participants’ age, and duration of exposure, using meta-regression methods.ResultsIn our primary analysis, we included 18 studies. A statistically significant 5% increase in the risk for PCa was observed among CCB users (risk ratio [RR] = 1.05; 95% confidence interval [CI]: 1.01-1.10), with no significant association between the duration of exposure to CCBs and the risk for PCa (RR = 1.08; 95% CI: 0.98-1.19 for exposure for < 5years and RR = 1.01; 95% CI: 0.9-1.14 for exposure ≥ 5 years). The association remained statistically significant for the subgroup of dihydropyridines (RR = 1.13; 95% CI: 1.05-1.22). In addition, the association was not influenced by participants’ age.Conclusion and RelevanceCCBs are an important modality in treating hypertension. The 5% increased risk observed in the current meta-analysis could be influenced by residual confounding factors and should not affect hypertension treatment guidelines until more studies provide additional clinical information.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-28T07:11:38Z
      DOI: 10.1177/10600280221098121
       
  • Estimation of Kidney Function in Patients With Multiple Myeloma:
           Implications for Lenalidomide Dosing

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      Authors: Engie Salama, Stepfanie Lam, Wilson I. Gonsalves, Dimitrios Tzachanis, Jeremiah D. Momper, Ila M. Saunders
      First page: 29
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundLenalidomide is an immunomodulatory drug used to treat multiple myeloma that requires renal dosing adjustment based on Cockcroft-Gault (CG). Various equations to estimate kidney function exist and pose a potential issue with lenalidomide dosing.ObjectiveThe objective of this analysis was to evaluate the impact of estimating kidney function in newly diagnosed multiple myeloma patients with CG, Modification of Diet in Renal Disease (MDRD), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and their potential impact on lenalidomide dosing.MethodsData from 1121 multiple myeloma patients at the time of diagnosis acquired from the Mayo Clinic were used to calculate creatinine clearance (CrCl) using Cockcroft-Gault with actual body weight (CGABW), ideal body weight (CGIBW), or adjusted body weight (CGAdjBW); MDRD; and CKD-EPI for each subject. Discordances in dosing were then analyzed, and lenalidomide exposure was calculated for each subject to assess impact on pharmacokinetics of lenalidomide for patients who received discordant doses.ResultsOverall, approximately 16% of patients received a discordant dose when using MDRD or CKD-EPI instead of CGABW. The most common dose discordance was the decrease of a full dose of lenalidomide 25 mg when using CGABW down to 10 mg and when using MDRD or CKD-EPI with 53.8% to 55.6% of all discordances in this category. When assessing different body weights, the most common discordance was a decrease from 25 to 10 mg when using CGIBW instead of CGABW; the same trend was observed when using CGAdjBW instead as well. Patients were also at risk of over- or underexposure based on area under the concentration versus time curve (AUC) for discordant dosing.Conclusion and RelevanceA significant proportion of patients are at risk of under- or overdose of lenalidomide if CKD-EPI or MDRD are used instead of CGABW. Physicians should use CGABW when estimating renal function to dose lenalidomide.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-05T03:41:33Z
      DOI: 10.1177/10600280221087218
       
  • Comparison of Two-Bag Versus Three-Bag N-Acetylcysteine Regimens for
           Pediatric Acetaminophen Toxicity

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      Authors: Sindhu Sudanagunta, Alexa Camarena-Michel, Stephanie Pennington, Jan Leonard, Christopher Hoyte, George Sam Wang
      First page: 36
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Acetaminophen overdose is a leading cause of liver failure, and a leading cause of pediatric poisoning requiring hospital admission. The antidote, N-acetylcysteine (NAC), is traditionally administered as a three-bag intravenous infusion. Despite its efficacy, NAC is associated with high incidence of nonallergic anaphylactoid reactions (NAARs). Adult evidence demonstrates that alternative dosing regimens decrease NAARs and medication errors (MEs).Objectives:To compare NAARs and MEs associated with two- versus three-bag NAC for acetaminophen overdose in a pediatric population.Methods:This is a retrospective observational cohort study comparing pediatric patients who received three- versus two-bag NAC for acetaminophen toxicity. The primary outcome was incidence of NAARs. Secondary outcomes were rates of MEs and relevant hospital outcomes (length of stay [LOS], intensive care unit (ICU) admission, liver transplant, death).Results:Two hundred forty-three patients met inclusion criteria (median age of 15 years): 150 (62%) three-bag NAC and 93 (38%) two-bag NAC. There was no difference in overall NAARs (p = 0.54). Fewer cutaneous NAARs were observed in the two-bag group, three-bag: 15 (10%), two-bag: 2 (2%), p = 0.02. MEs were significantly decreased with the two-bag regimen, three-bag: 59 (39%), two-bag: 21 (23%), p = 0.01. No statistical differences were observed in LOS, ICU admissions, transplant, or death.Conclusion and relevance:A significant decrease in cutaneous NAARs and MEs was observed in pediatric patients by combining the first two bags of the traditional three-bag NAC regimen. In pediatric populations, a two-bag NAC regimen for acetaminophen overdose may improve medication tolerance and safety.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-19T10:55:16Z
      DOI: 10.1177/10600280221097700
       
  • Relationship Between Mean Arterial Pressure and Furosemide Stress Test
           Success Rates: A Retrospective Cohort Study

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      Authors: Haley M. Fox, Jacob H. DeCleene
      First page: 44
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundThe furosemide stress test (FST) is a safe and easy assessment of renal tubular function. Other factors, such as mean arterial pressure (MAP), which may influence the success rates of the FST, have not been well defined.ObjectiveTo evaluate the relationship between MAP and success rates of the FST in critically ill patients.MethodsRetrospective, single-center, institutional review board (IRB)-approved cohort study. Critically ill adult patients given at least one dose of intravenous (IV) furosemide (≥1-1.5 mg/kg) were included. Primary outcome was whether a MAP ≥ 75 mm Hg would equate to a higher FST success rate. Secondary outcome was the success rates of patient on one or more vasopressors.ResultsOf 225 patients, 88 (39.1%) had a successful FST. In patients with a MAP ≥ 75 mm Hg, 60 out of 104 (57.7%) had a successful FST compared to 28 out of 121 (23.1%) of patients who had a MAP < 75 mm Hg (odds ratio [OR], 4.53, 95% CI, 2.55-8.74, P < 0.001). Patients on vasopressors at the time of the furosemide dose had lower rates of success compared to those not on vasoactive agents (30.4% versus 68.2%, p = 0.026). Limitations of this study include its retrospective design and reliance on documented urine output.Conclusion and RelevancePatients with a MAP ≥ 75 mm Hg were significantly more likely to have a successful FST compared to those with a MAP < 75 mm Hg. This represents the first report of factors that may influence FST success rates.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-14T07:38:20Z
      DOI: 10.1177/10600280221096466
       
  • Hyperglycemia Post-Influenza Vaccine in Patients With Diabetes

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      Authors: Abigail L. Hulsizer, Amy P. Witte, Rebecca L. Attridge, Elizabeth M. Urteaga
      First page: 51
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundThere are more than 350 reports of hyperglycemia post-influenza vaccine according to the Vaccine Adverse Effect Reporting System. Only one case report has been published detailing unusual post-vaccination hyperglycemia. The mechanism as to why hyperglycemia may occur post-vaccination has not been fully elucidated.ObjectivePrimary: To identify hyperglycemia within the first 24 hours of influenza vaccine. Secondary: To identify transient property of hyperglycemia within 4 days after vaccine.MethodsMulticenter prospective cohort study. Recruitment conducted throughout San Antonio, Texas, during 2018-2020 influenza seasons. Patients were included if 18 years or older, had diabetes mellitus, and currently checking their blood glucose daily. Patients excluded if they had a recent medication change that would effect their blood glucose readings. Patients had hemoglobin A1c and blood glucose measured prior to vaccination with a single dose (0.5 mL) of the tri-valent influenza vaccine intramuscularly. Glucose readings were collected within 24 hours post-vaccination and subsequent mornings for 4 days.ResultsA total of 34 patients were included. Average patient age was 75 years with 60% white, 30% black, and 10% Hispanic. Median fasting glucose pre-vaccination was significantly lower than the median value 0 to 24 hours post-vaccination (140 vs 203 mg/dL, P < 0.0001).Conclusion and RelevanceHyperglycemia was noted 0 to 24 hours post-vaccination and was transient in nature with a return to baseline by post-vaccination day 2. This trial was conducted to close a potential gap in counseling regarding the flu vaccine and decrease any potential concern surrounding the vaccine in patients with diabetes that could lead to reduced vaccination rates.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-06-02T01:31:23Z
      DOI: 10.1177/10600280221098101
       
  • Outcomes of a Undiluted, One-Bag Desensitization Protocol for
           Chemotherapeutic Agents

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      Authors: Araceli Iglesias-Santamaría, Paloma Castellano Copa
      First page: 55
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundHypersensitive reactions (HSRs) often require that the provoking medication be discontinued but chemotherapeutic drugs are often essential for the treatment of the disease. Rapid drug desensitization is a procedure that induces temporary tolerance to the drug allowing continuation of treatment in patients who have presented HSRs. Most of the desensitization protocols use 3 bags with sequential dilutions of the drug, which are infused in gradual steps. However, it has not been sufficiently investigated whether dilution is essential for successful desensitization.ObjectiveThe objective of this study was to evaluate the efficacy and safety of a new one-bag desensitization protocol which uses a single solution of 1 mg/mL throughout the procedure allowing to reduce time and simplifying the desensitization procedure.MethodsRetrospective observational study was carried out in adult patients with HSRs to chemotherapy agents who received a new nondilution one-bag desensitization protocol between 2016 and 2021.ResultsA total of 130 desensitization procedures with an undiluted one-bag protocol were performed on 17 patients with HSRs to chemotherapy. One hundred and seven (82.3%) were for desensitization to CBDCA, 15 (11.5%) for oxaliplatin, 4 (3.1%) for paclitaxel and 4 (3.1%) for brentuximab. All of the 130 procedures were successfully accomplished, and all patients could receive their target dose. No breakthrough reactions (BTRs) occurred in 77% (100/130) of desensitizations, and only mild reactions (grade 1) with skin symptoms were observed in 23% (30/130) of desensitizations.Conclusion and RelevanceThe undiluted one-bag desensitization protocol was safe and effective and has been adopted as the standard of care at our institution in treating patients with HSRs to chemotherapeutic drugs as it requires less time and simplifies the desensitization procedure, optimizing risk management.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-14T07:33:26Z
      DOI: 10.1177/10600280221093594
       
  • Tezepelumab in the Treatment of Uncontrolled Severe Asthma

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      Authors: Jacqueline Feist, Melissa Lipari, Pramodini Kale-Pradhan
      First page: 62
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review the pharmacology, efficacy, and safety of subcutaneous tezepelumab in the treatment of severe uncontrolled asthma.Data Sources:The PubMed database and ClinicalTrials.gov were searched using the following terms: tezepelumab, Tezspire, AMG157, and MEDI9929.Study Selection and Data Extraction:Articles published in English between January 2000 and March 2022 related to pharmacology, safety, and clinical trials were assessed.Data Synthesis:In a phase 2 trial, tezepelumab at low, medium, and high doses reduced the annualized asthma exacerbation rate by 62%, 71%, and 66%, respectively, when compared with placebo (P < 0.001). In addition to significant reduction of asthma exacerbation rate in the overall treatment population, a phase 3 trial showed significant reduction of asthma exacerbation across all subgroups analyzed regardless of serum eosinophil count (EOS), fractionated exhaled nitric oxide (FeNO) level, or allergic status as determined by IgE sensitivity.Relevance to Patient Care and Clinical Practice:Tezepelumab is indicated to treat nonallergic and noneosinophilic severe uncontrolled asthma phenotypes in addition to type 2 inflammatory asthma. When selecting the most appropriate biologic agent, consider the risks, benefits, and costs. There is a paucity of data on the efficacy of tezepelumab in patients with comorbid conditions. In the case of a patient presenting with uncontrolled severe asthma with such comorbid conditions, it may be prudent to consider a biologic therapy that can target both.Conclusion:Tezepelumab has shown clinical utility in severe uncontrolled asthma regardless of phenotype, fulfilling the need for treatment options in individuals with severe, uncontrolled, noneosinophilic, and nonallergic asthma.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-10T07:30:15Z
      DOI: 10.1177/10600280221095540
       
  • Bupivacaine/meloxicam ER: A New Dual-acting Extended-Release Local
           Anesthetic for Opioid-Sparing Postoperative Pain Management

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      Authors: Taylor Bourn, Sister Michaela Serpa
      First page: 71
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo review data for bupivacaine/meloxicam extended-release (ER) solution for management of postoperative pain and opioid-sparing effects.Data SourcesLiterature search of PubMed (1946 to August 2021) and ProQuest (1946 to August 2021) was performed using the terms: Zynrelef, HTX-011, and “bupivacaine AND meloxicam.” Additional information sources include ClinicalTrials.gov, prescribing information, Heron Therapeutics’ Clinical and Economic Evidence Dossier, meeting abstracts, and references of identified articles.Study Selection and Data ExtractionClinical trials and articles evaluating bupivacaine/meloxicam ER for postoperative pain management.Data SynthesisBupivacaine is a short-acting local anesthetic. Its efficacy is negatively impacted by the acidic environment of surgical sites. Meloxicam, a nonsteroidal antiinflammatory, reduces inflammation at the surgical site and increases pH propagating bupivacaine movement into the neurons. In Phase 2 and Phase 3 clinical trials, bupivacaine/meloxicam ER was compared with bupivacaine HCl, bupivacaine ER, and meloxicam ER with and without scheduled nonopioid multimodal analgesia (MMA) in bunionectomies, herniorrhaphies, total knee arthroplasty and abdominoplasty. Postoperative pain was well controlled for 72 hours and consistently superior to placebo, with minimal or no opioid use. Wound healing was not impacted and adverse effects were similar to placebo (most commonly nausea, dizziness, constipation, and headaches).Relevance to Patient Care and Clinical PracticeBupivacaine/meloxicam ER is a viable, safe, nonopioid local anesthetic for sustained 72-hour postoperative pain management mitigating opioid consumption.ConclusionBupivacaine/meloxicam ER is the only dual-acting, extended-release local anesthetic available. It provides effective analgesia in the postoperative setting and successfully reduces or eliminates postoperative opioid consumption.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-10T02:04:13Z
      DOI: 10.1177/10600280221086639
       
  • Abrocitinib: A New FDA-Approved Drug for Moderate-to-Severe Atopic
           Dermatitis

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      Authors: Patrick O. Perche, Madison K. Cook, Steven R. Feldman
      First page: 86
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveThe objective of this article is to review abrocitinib, an oral Janus kinase (JAK) 1 inhibitor, for the treatment of patients with moderate-to-severe atopic dermatitis (AD).Data SourcesA literature search of MEDLINE (PubMed) was performed for articles from inception through end-March 2022 using the following search terms: atopic dermatitis, abrocitinib, PF-04965842, methotrexate, cyclosporine, dupilumab, ruxolitinib, and JAK-STAT pathway.Study Selection and Data ExtractionEnglish articles relating to pharmacology, pharmacokinetics, efficacy, and safety of abrocitinib, and other conventional systemic medications for AD, were included.Data SynthesisAcross phase IIb and phase III clinical trials, abrocitinib was efficacious with an average of 47.5% patients on 200 mg abrocitinib and 32.0% on 100 mg abrocitinib achieving an Investigator’s Global Assessment (IGA) of 0 or 1 at 12 weeks. In comparison with dupilumab 300 mg subcutaneously every other week, patients on abrocitinib 200 mg once daily had improved disease severity and itch response. The majority of adverse events were not severe and self-limited.Relevance to Patient Care and Clinical PracticePrior to Food and Drug Administration (FDA) approval of abrocitinib, prednisone was the only FDA-approved oral medication for AD. Although biologics such as dupilumab have revolutionized care, some patients prefer oral medications. Compared with clinical trials of conventional AD treatments, abrocitinib appears more effective.ConclusionsAbrocitinib is an efficacious oral JAK 1 inhibitor recently FDA-approved for patients ≥ 18 years old with moderate-to-severe AD who have not responded to systemic medications or when contraindicated otherwise.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-19T10:53:12Z
      DOI: 10.1177/10600280221096713
       
  • Ibrexafungerp in the Treatment of Vulvovaginal Candidiasis

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      Authors: Kylie N. Barnes, Abigail M. Yancey, Alicia B. Forinash
      First page: 99
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo review the pharmacology, efficacy, and safety of ibrexafungerp in the management of vulvovaginal candidiasis (VVC).Data SourcesLiterature was sought using PubMed (1966—February 2022) and EMBASE (1973—February 2022), and clinicaltrials.gov. Search terms included ibrexafungerp, SCY-078, and VVC.Study Selection and Data ExtractionAll studies including humans and published in English with data assessing the efficacy and safety of ibrexafungerp for the treatment of VVC were evaluated.Data SynthesisA phase 2 dose-finding study found ibrexafungerp had similar efficacy to fluconazole in the clinical cure of VVC (51.9% vs 58.3%, respectively). Two phase 3 clinical trials demonstrated ibrexafungerp had statistical superiority over placebo for clinical cure in moderate to severe VVC (P < 0.001 and P = 0.023, respectively). The most frequently reported adverse reactions in the clinical trials were gastrointestinal-related symptoms. To date, data comparing efficacy of ibrexafungerp and topical imidazoles in the treatment of VVC are nonexistent.Relevance to Patient Care and Clinical PracticeTopical imidazoles and oral fluconazole are effective for the treatment of uncomplicated VVC. Due to increased resistance, limited fluconazole coverage for non-Candida albicans species, and potential for significant drug interactions associated with fluconazole use, alternative treatments for VVC are needed. Ibrexafungerp is a new oral triterpenoid antifungal agent indicated for the treatment of VVC. Additional clinical trials are needed to evaluate long-term safety data as well as efficacy and safety in specialty populations.ConclusionIbrexafungerp, a recently approved triterpenoid antifungal agent, is an effective and well-tolerated option for the treatment of VVC.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-03T05:57:26Z
      DOI: 10.1177/10600280221091301
       
  • Considerations When Using Body Mass Index as a Size Descriptor

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      Authors: Brian L. Erstad, David E. Nix
      First page: 107
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-20T04:30:55Z
      DOI: 10.1177/10600280221097968
       
  • Successful Desensitization to Remdesivir Hypersensitivity in a Patient
           Undergoing Treatment for COVID-19

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      Authors: Da Woon Sim, Eun Myoung, Son Hoyoung
      First page: 110
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-18T08:24:30Z
      DOI: 10.1177/10600280221096883
       
  • Comment: Pharmacists Have the Stats but No Provider Status—Now May
           Be Our Moment

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      Authors: Craig Yon, Gretchen Ray, Keenan Ryan
      First page: 113
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-05T03:43:33Z
      DOI: 10.1177/10600280221088002
       
 
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