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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
Showing 1 - 200 of 253 Journals sorted alphabetically
AAPS Journal     Hybrid Journal   (Followers: 24)
AAPS Open     Open Access   (Followers: 4)
AAPS PharmSciTech     Hybrid Journal   (Followers: 6)
AboutOpen     Open Access  
ACS Pharmacology & Translational Science     Hybrid Journal   (Followers: 3)
Acta Pharmaceutica     Open Access   (Followers: 4)
Acta Pharmaceutica Indonesia     Open Access  
Acta Pharmaceutica Sinica B     Open Access   (Followers: 1)
Acta Pharmacologica Sinica     Hybrid Journal   (Followers: 3)
Acta Physiologica Hungarica     Full-text available via subscription  
Actualites Pharmaceutiques     Full-text available via subscription   (Followers: 4)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 93)
Advanced Herbal Medicine     Open Access   (Followers: 8)
Advanced Therapeutics     Hybrid Journal   (Followers: 1)
Advances in Pharmacoepidemiology & Drug Safety     Open Access   (Followers: 2)
Advances in Pharmacological and Pharmaceutical Sciences     Open Access   (Followers: 9)
Advances in Pharmacology     Full-text available via subscription   (Followers: 17)
Advances in Pharmacology and Pharmacy     Open Access   (Followers: 5)
Advances in Traditional Medicine     Hybrid Journal   (Followers: 3)
Adverse Drug Reaction Bulletin     Full-text available via subscription   (Followers: 5)
AJP : The Australian Journal of Pharmacy     Full-text available via subscription   (Followers: 8)
Alternatives to Laboratory Animals     Full-text available via subscription   (Followers: 9)
American Journal of Cardiovascular Drugs     Hybrid Journal   (Followers: 20)
American Journal of Drug Discovery and Development     Open Access   (Followers: 3)
American Journal of Health-System Pharmacy     Full-text available via subscription   (Followers: 54)
American Journal of Pharmacological Sciences     Open Access   (Followers: 1)
American Journal of Pharmacology and Toxicology     Open Access   (Followers: 23)
American Journal of Therapeutics     Hybrid Journal   (Followers: 13)
Analytical Methods     Hybrid Journal   (Followers: 8)
Annales Pharmaceutiques Francaises     Full-text available via subscription  
Annals of Pharmacotherapy     Hybrid Journal   (Followers: 56)
Annual Review of Pharmacology and Toxicology     Full-text available via subscription   (Followers: 36)
Anti-Infective Agents     Hybrid Journal   (Followers: 5)
Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry     Hybrid Journal   (Followers: 5)
Antibiotics     Open Access   (Followers: 11)
Antibody Therapeutics     Open Access  
Antiviral Chemistry and Chemotherapy     Open Access   (Followers: 1)
Antiviral Research     Hybrid Journal   (Followers: 8)
Applied Clinical Trials     Full-text available via subscription   (Followers: 7)
Archiv der Pharmazie     Hybrid Journal   (Followers: 2)
Archives of Drug Information     Hybrid Journal   (Followers: 4)
Archives of Pharmacal Research     Full-text available via subscription   (Followers: 2)
Archives of Pharmacy and Pharmaceutical Sciences     Open Access   (Followers: 1)
Archives of Razi Institute     Open Access  
Archivos Venezolanos de Farmacología y Terapéutica     Open Access  
Ars Pharmaceutica     Open Access  
Asian Journal of Medical and Pharmaceutical Researches     Open Access  
Asian Journal of Pharmaceutical Research and Health Care     Open Access   (Followers: 2)
Asian Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
Asian Journal of Pharmaceutics     Open Access   (Followers: 1)
Asian Journal of Research in Medical and Pharmaceutical Sciences     Open Access  
ASSAY and Drug Development Technologies     Hybrid Journal   (Followers: 3)
Australian Journal of Herbal Medicine     Full-text available via subscription   (Followers: 4)
Australian Pharmacist     Full-text available via subscription   (Followers: 7)
Autonomic & Autacoid Pharmacology     Hybrid Journal  
Avicenna Journal of Phytomedicine     Open Access   (Followers: 1)
Bangladesh Journal of Pharmacology     Open Access  
Bangladesh Journal of Physiology and Pharmacology     Open Access  
Bangladesh Pharmaceutical Journal     Full-text available via subscription  
Basic & Clinical Pharmacology & Toxicology     Hybrid Journal   (Followers: 14)
Behavioural Pharmacology     Hybrid Journal   (Followers: 2)
Bioanalysis     Full-text available via subscription   (Followers: 11)
Biochemical Pharmacology     Hybrid Journal   (Followers: 10)
BioDrugs     Full-text available via subscription   (Followers: 8)
Biological & Pharmaceutical Bulletin     Full-text available via subscription   (Followers: 3)
Biomarkers in Drug Development     Partially Free   (Followers: 2)
Biomaterials     Hybrid Journal   (Followers: 55)
Biomedical and Environmental Sciences     Full-text available via subscription   (Followers: 1)
Biomedicine & Pharmacotherapy     Full-text available via subscription   (Followers: 2)
Biometrical Journal     Hybrid Journal   (Followers: 9)
Biopharm International     Full-text available via subscription   (Followers: 20)
Biopharmaceutics and Drug Disposition     Hybrid Journal   (Followers: 10)
BMC Pharmacology     Open Access   (Followers: 2)
BMC Pharmacology & Toxicology     Open Access   (Followers: 8)
Brazilian Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
British Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 30)
British Journal of Pharmacology     Hybrid Journal   (Followers: 17)
British Journal of Pharmacy (BJPharm)     Open Access   (Followers: 2)
Bulletin of Faculty of Pharmacy, Cairo University     Open Access   (Followers: 2)
CADTH Technology Overviews     Free  
Canadian Journal of Pain     Open Access   (Followers: 3)
Canadian Journal of Physiology and Pharmacology     Hybrid Journal   (Followers: 2)
Canadian Pharmacists Journal / Revue des Pharmaciens du Canada     Hybrid Journal   (Followers: 3)
Cancer Biotherapy & Radiopharmaceuticals     Hybrid Journal  
Cancer Chemotherapy and Pharmacology     Hybrid Journal   (Followers: 4)
Cardiovascular Drugs and Therapy     Hybrid Journal   (Followers: 14)
Cardiovascular Therapeutics     Open Access   (Followers: 3)
Cephalalgia Reports     Open Access  
Chemical and Pharmaceutical Bulletin     Full-text available via subscription   (Followers: 1)
Chemical Research in Toxicology     Hybrid Journal   (Followers: 22)
ChemMedChem     Hybrid Journal   (Followers: 9)
Chemotherapy     Full-text available via subscription   (Followers: 3)
Chinese Herbal Medicines     Full-text available via subscription   (Followers: 1)
Chinese Journal of Pharmaceutical Analysis     Full-text available via subscription  
Ciencia e Investigación     Open Access  
Ciência Equatorial     Open Access  
Clinical and Experimental Pharmacology and Physiology     Hybrid Journal   (Followers: 7)
Clinical and Translational Science     Open Access   (Followers: 4)
Clinical Complementary Medicine and Pharmacology     Open Access  
Clinical Drug Investigation     Full-text available via subscription   (Followers: 8)
Clinical Medicine Insights : Therapeutics     Open Access  
Clinical Neuropharmacology     Hybrid Journal   (Followers: 2)
Clinical Pharmacist     Partially Free   (Followers: 12)
Clinical Pharmacokinetics     Full-text available via subscription   (Followers: 28)
Clinical Pharmacology & Therapeutics     Hybrid Journal   (Followers: 45)
Clinical Pharmacology in Drug Development     Hybrid Journal   (Followers: 4)
Clinical Pharmacology: Advances and Applications     Open Access   (Followers: 6)
Clinical Research and Regulatory Affairs     Hybrid Journal   (Followers: 12)
Clinical Therapeutics     Hybrid Journal   (Followers: 34)
Clinical Toxicology     Hybrid Journal   (Followers: 18)
Clinical Trials     Hybrid Journal   (Followers: 18)
CNS Drug Reviews     Open Access   (Followers: 4)
CNS Drugs     Full-text available via subscription   (Followers: 10)
Combination Products in Therapy     Open Access  
Consultant Pharmacist     Full-text available via subscription   (Followers: 2)
Consumer Drugs     Full-text available via subscription  
Contract Pharma     Full-text available via subscription  
Cosmetics     Open Access   (Followers: 4)
CPT : Pharmacometrics & Systems Pharmacology     Open Access   (Followers: 11)
Critical Reviews in Clinical Laboratory Sciences     Hybrid Journal   (Followers: 16)
Critical Reviews in Therapeutic Drug Carrier Systems     Full-text available via subscription   (Followers: 5)
Critical Reviews in Toxicology     Hybrid Journal   (Followers: 25)
Current Bioactive Compounds     Hybrid Journal  
Current Cancer Therapy Reviews     Hybrid Journal   (Followers: 5)
Current Clinical Pharmacology     Hybrid Journal   (Followers: 4)
Current Drug Delivery     Hybrid Journal   (Followers: 6)
Current Drug Discovery Technologies     Hybrid Journal   (Followers: 6)
Current Drug Metabolism     Hybrid Journal   (Followers: 5)
Current Drug Safety     Hybrid Journal   (Followers: 8)
Current Drug Targets     Hybrid Journal   (Followers: 5)
Current Drug Therapy     Hybrid Journal   (Followers: 3)
Current Enzyme Inhibition     Hybrid Journal   (Followers: 1)
Current Issues in Pharmacy and Medical Sciences     Open Access   (Followers: 2)
Current Medical Science     Hybrid Journal  
Current Medicinal Chemistry     Hybrid Journal   (Followers: 13)
Current Molecular Pharmacology     Hybrid Journal  
Current Nanoscience     Hybrid Journal  
Current Neuropharmacology     Hybrid Journal   (Followers: 1)
Current Opinion in Pharmacology     Hybrid Journal   (Followers: 9)
Current Pharmaceutical Analysis     Hybrid Journal   (Followers: 1)
Current Pharmaceutical Biotechnology     Hybrid Journal   (Followers: 10)
Current Pharmaceutical Design     Hybrid Journal   (Followers: 11)
Current Pharmacogenomics and Personalized Medicine     Hybrid Journal   (Followers: 3)
Current Pharmacology Reports     Hybrid Journal  
Current Protocols in Pharmacology     Hybrid Journal  
Current Radiopharmaceuticals     Hybrid Journal   (Followers: 1)
Current Research in Drug Discovery     Open Access   (Followers: 2)
Current Research in Pharmacology and Drug Discovery     Open Access   (Followers: 1)
Current Therapeutic Research     Open Access   (Followers: 6)
Current trends in Biotechnology and Pharmacy     Open Access   (Followers: 8)
Current Vascular Pharmacology     Hybrid Journal   (Followers: 4)
Dhaka University Journal of Pharmaceutical Sciences     Open Access  
Die Pharmazie - An International Journal of Pharmaceutical Sciences     Full-text available via subscription   (Followers: 5)
Dose-Response     Open Access  
Drug and Chemical Toxicology     Hybrid Journal   (Followers: 13)
Drug and Therapeutics Bulletin     Hybrid Journal   (Followers: 8)
Drug Delivery     Open Access   (Followers: 8)
Drug Delivery and Translational Research     Hybrid Journal   (Followers: 2)
Drug Design, Development and Therapy     Open Access   (Followers: 3)
Drug Development and Industrial Pharmacy     Hybrid Journal   (Followers: 29)
Drug Development Research     Hybrid Journal   (Followers: 11)
Drug Discovery Today: Technologies     Full-text available via subscription   (Followers: 12)
Drug Metabolism and Disposition     Hybrid Journal   (Followers: 13)
Drug Metabolism and Pharmacokinetics     Hybrid Journal   (Followers: 6)
Drug Metabolism Letters     Hybrid Journal   (Followers: 3)
Drug Metabolism Reviews     Hybrid Journal   (Followers: 8)
Drug Research     Hybrid Journal   (Followers: 3)
Drug Resistance Updates     Hybrid Journal   (Followers: 3)
Drug Safety     Full-text available via subscription   (Followers: 79)
Drug Safety - Case Reports     Open Access   (Followers: 2)
Drug Target Insights     Open Access  
Drug, Healthcare and Patient Safety     Open Access   (Followers: 10)
Drugs     Full-text available via subscription   (Followers: 123)
Drugs & Aging     Full-text available via subscription   (Followers: 9)
Drugs & Therapy Perspectives     Full-text available via subscription   (Followers: 9)
Drugs : Real World Outcomes     Hybrid Journal   (Followers: 1)
Drugs and Therapy Studies     Open Access  
Drugs in R & D     Full-text available via subscription   (Followers: 2)
Drugs of the Future     Full-text available via subscription   (Followers: 8)
East and Central African Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
Egyptian Pharmaceutical Journal     Open Access  
EJNMMI Radiopharmacy and Chemistry     Open Access  
EMC - Cosmetologia Medica e Medicina degli Inestetismi Cutanei     Full-text available via subscription  
Emerging Trends in Drugs, Addictions, and Health     Open Access  
Environmental Toxicology and Pharmacology     Hybrid Journal   (Followers: 9)
Epilepsy Research     Hybrid Journal   (Followers: 7)
Ethiopian Pharmaceutical Journal     Full-text available via subscription   (Followers: 1)
EUREKA : Health Sciences     Open Access  
European Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 14)
European Journal of Drug Metabolism and Pharmacokinetics     Hybrid Journal   (Followers: 8)
European Journal of Hospital Pharmacy : Science and Practice (EJHP)     Hybrid Journal   (Followers: 5)
European Journal of Medicinal Plants     Open Access   (Followers: 2)
European Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 84)
European Journal of Pharmaceutics and Biopharmaceutics     Hybrid Journal   (Followers: 34)
European Journal of Pharmacology     Hybrid Journal   (Followers: 8)
European Neuropsychopharmacology     Hybrid Journal   (Followers: 9)
European Review for Medical and Pharmacological Sciences     Full-text available via subscription   (Followers: 1)
Experimental and Clinical Psychopharmacology     Full-text available via subscription   (Followers: 7)
Expert Opinion on Drug Delivery     Hybrid Journal   (Followers: 17)
Expert Opinion on Drug Discovery     Hybrid Journal   (Followers: 18)

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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  [1174 journals]
  • 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
       
  • 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
      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
       
  • 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
      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
       
  • Considerations When Using Body Mass Index as a Size Descriptor

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

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-20T04:30:55Z
      DOI: 10.1177/10600280221097968
       
  • 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
      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
       
  • 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
      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
       
  • 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
      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
       
  • 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
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-18T08:24:30Z
      DOI: 10.1177/10600280221096883
       
  • 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
      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
       
  • Outcomes of a Undiluted, One-Bag Desensitization Protocol for
           Chemotherapeutic Agents

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      Authors: Araceli Iglesias-Santamaría, Paloma Castellano Copa
      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
      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
      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
       
  • 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
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-05T03:43:33Z
      DOI: 10.1177/10600280221088002
       
  • 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
      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
       
  • Efficacy of Eravacycline Versus Best Previously Available Therapy for
           Adults With Pneumonia Due to Difficult-to-Treat Resistant (DTR)
           Acinetobacter baumannii

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      Authors: Courtney J. Scott, Elizabeth Zhu, Rebecca A. Jayakumar, Guogen Shan, Velliyur Viswesh
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundMultidrug-resistant Acinetobacter baumannii remains challenging to treat. Although eravacycline has in vitro activity against this pathogen, there are no studies evaluating outcomes.ObjectiveTo assess the efficacy of eravacycline compared with best previously available therapy in adults with difficult-to-treat resistant (DTR) A. baumannii pneumonia.MethodsThis was a retrospective study of adults hospitalized for pneumonia with DTR A. baumannii. Patients receiving eravacycline were compared with those receiving best previously available therapy. The primary outcome was 30-day in-hospital mortality. Secondary outcomes included clinical cure at Day 14, hospital and intensive care unit (ICU) length of stay, microbiologic cure, and readmission within 90 days with a positive A. baumannii respiratory culture.ResultsNinety-three patients were included, with 27 receiving eravacycline. Eravacycline was associated with higher 30-day mortality (33% vs 15%; P = 0.048), lower microbiologic cure (17% vs 59%; P = 0.004), and longer durations of mechanical ventilation (10.5 vs 6.5 days; P = 0.016). At baseline, eravacycline patients had more A. baumannii bacteremia and coinfection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Among bacteremic patients, all 4 receiving eravacycline died by Day 30 and both patients receiving best previously available therapy survived. Upon exclusion of patients with bacteremia and SARS-CoV-2, there were no differences between the groups across any outcomes.ConclusionsEravacycline-based combination therapy had similar outcomes to best previously available combination therapy for adults with DTR A. baumannii pneumonia. However, eravacycline should be used with caution in the setting of bacteremia as outcomes were poor in this population.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-05T03:38:51Z
      DOI: 10.1177/10600280221085551
       
  • Management of Venous Thromboembolism in Morbid Obesity With Rivaroxaban or
           Warfarin

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      Authors: Paige Weaver, Tsz Hin Ng, Thomas Breeden, Stephanie B. Edwin, Bradley Haan, Christopher Giuliano
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundRivaroxaban is a first-line option for the management of venous thromboembolism (VTE). However, limited data are available regarding its effectiveness in morbidly obese patients.ObjectiveTo evaluate rates of thrombosis and bleeding in morbidly obese patients receiving rivaroxaban or warfarin for VTE.MethodsA multicenter, retrospective cohort study was conducted to compare rates of bleeding and thrombosis in patients receiving rivaroxaban versus warfarin for acute VTE. Patients were included if they were older than 18 years and had a body mass index (BMI) greater than 40 kg/m2 or weight greater than 120 kg. The primary effectiveness outcome was hazard of VTE recurrence; the primary safety outcome was hazard of major bleeding. Patients were followed for up to 12 months.ResultsA total of 1281 patients were identified for acute VTE and were included in this study with 487 patients receiving rivaroxaban and 785 receiving warfarin. The average cohort age was 57.6 ± 14.6 years, and the average weight was 136.4 ± 27.2 kg. After controlling for confounding factors, the use of rivaroxaban was not associated with an increased hazard of VTE events when compared with warfarin (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.42-1.08, P = 0.12) or major bleeding (HR = 1.29, 95% CI: 0.66-2.30, P = 0.52).Conclusion and RelevanceNo difference was observed in obese patients with weight>120 kg or BMI>40 kg/m2 receiving rivaroxaban or warfarin for VTE treatment in hazard of VTE or major bleeding. Either agent may be considered an appropriate treatment option in this population.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-04T05:38:13Z
      DOI: 10.1177/10600280221089008
       
  • Criminal Action Against Drug Counterfeiters: Assessment of the FDA Office
           of Criminal Investigation Database 2016 Through 2021

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      Authors: C. Michael White
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveThe objective of this study was to describe law enforcement oversight of counterfeit drugs by the Food and Drug Administration (FDA) in the United States from 2016 through 2021.MethodsThe FDA Office of Criminal Investigation database with hyperlinked press releases of enforcement actions was used to identify legal action against drug counterfeiters. Incidences of counterfeit drugs sold via Internet, how often they were obtained without a prescription, the most prevalent counterfeit drugs, the countries where counterfeit operations occurred, and the scale of counterfeit operations were assessed.ResultsThere were 130 unique enforcement actions against counterfeiting organizations and individuals. Overall, 64.6% of enforcement actions involved counterfeit products sold over the Internet, in 84.6% of actions counterfeit medications could be obtained without a prescription, and in 33.1% of actions the products were sold as dietary supplements. Sexual dysfunction, opioid, stimulant, anabolic muscle building, benzodiazepine, and dermatologic drugs were most counterfeited. China was the most prevalent country to produce counterfeit drugs followed by India, Turkey, Pakistan, and Russia. Counterfeiting operations were large with tens of millions of pills and hundreds of millions of dollars in sales. Health outcomes for counterfeit drugs were rarely discussed in the press releases and not all press releases had data for each parameter of interest.Conclusion and RelevanceThis is the first report assessing enforcement actions against drug counterfeiters from the FDA Office of Criminal Investigation. The FDA is actively involved in identifying and prosecuting counterfeit drug rings, but the number of enforcement actions is smaller than the size of the problem.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-03T06:12:48Z
      DOI: 10.1177/10600280221092482
       
  • Ibrexafungerp in the Treatment of Vulvovaginal Candidiasis

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      Authors: Kylie N. Barnes, Abigail M. Yancey, Alicia B. Forinash
      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
       
  • Reply: Antiplatelet Use in Ischemic Stroke

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      Authors: Marharyta Kamarova, Arshad Majid, Simon M. Bell
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-03T05:31:56Z
      DOI: 10.1177/10600280221096865
       
  • Comment: Antiplatelet Use in Ischemic Stroke

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      Authors: Harn J. Shiue, Kathryn A. Norville, Jenna L. Reynolds, Kara A. Sands
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-03T05:30:35Z
      DOI: 10.1177/10600280221096862
       
  • Comparison of Managing Factor Xa Inhibitor to Unfractionated Heparin
           Transitions by aPTT Versus a Treatment Guideline Utilizing Heparin Anti-Xa
           Levels

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      Authors: Scott J. Dingus, Alex R. Smith, William E. Dager, Sara Zochert, Salli A. Nothdurft, Michael P. Gulseth
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundThere are inadequate data on the optimal strategy for transitioning factor Xa inhibitors (FXai; apixaban, rivaroxaban) to unfractionated heparin (UFH) infusions.ObjectiveIn patients transitioning from an FXai to an UFH infusion, this study compared the safety and efficacy of monitoring UFH infusions using an activated partial thromboplastin time (aPTT) titration scale versus utilizing an UFH-calibrated anti-Xa titration scale aided by a novel institutional guideline.MethodsA retrospective cohort analysis was conducted on adult patients transitioning from an FXai to an UFH infusion at 2 medical centers from June 1, 2018, to November 1, 2020. One institution utilized aPTT while the other institution primarily used UFH-calibrated anti-Xa. The primary endpoint was a composite of death, major bleeding, or new thrombosis during the hospitalization with a planned noninferiority analysis. Secondary outcomes were also collected including the amount and duration of UFH administered between cohorts.ResultsThe incidence rate of the primary composite endpoint was 6.3% in the anti-Xa group and 11% in the aPTT group (P < 0.001 for noninferiority, P = 0.138 for superiority) meeting noninferiority criteria. No statistical differences were seen in new thrombosis, major bleeding, or any bleeding.Conclusion and RelevanceThis represents the first report of a comparison between aPTT versus anti-Xa monitoring in relation to clinical outcomes for patients transitioning from an FXai to an UFH infusion. A transition guideline primarily utilizing an UFH-calibrated anti-Xa assay appears to be a safe alternative to aPTT monitoring and can aid facilities in the management of patients during these complex transitions.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-02T12:59:32Z
      DOI: 10.1177/10600280221090211
       
  • Two Years of the COVID-19 Pandemic: What Lessons Have We Learned'

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      Authors: Shannon Inglet
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Two years ago, the World Health Organization declared a global pandemic after an outbreak of a novel coronavirus. Since then, unprecedented challenges have shaped a “new normal.” As of early March 2022, more than 6 million lives have been lost globally to COVID-19. But we have learned much over the past 2 years. Some lessons have been heartening, inspiring innovation, and adaptability; others have been devastating and will have reverberating consequences for years to come. The COVID-19 pandemic has taught us lessons that span medical, economic, social, and environmental arenas. And we still have much to learn.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-05-02T10:23:03Z
      DOI: 10.1177/10600280221090590
       
  • Evaluation of Ceftazidime Use in the Neonatal Intensive Care Unit and
           Association With Cephalosporin-Resistant Gram-Negative Bacteria

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      Authors: Rebecca A. Mayes, Peter N. Johnson, Bryan P. White, Stephen B. Neely, Hala Chaaban, Jamie L. Miller
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundCefotaxime shortage in 2015 led to increased ceftazidime use in the neonatal intensive care unit (NICU).ObjectiveThe purpose was to explore whether ceftazidime increases risk for development of resistant gram-negative organisms.MethodsRetrospective evaluation of NICU patients with cultures positive for Escherichia coli, Pseudomonas aeruginosa, Klebsiella species, or Stenotrophomonas maltophilia between January1, 2015 and August 31, 2020. Isolates were excluded if obtained from same patient and source within 90 days or if patient ≤7 days of life or admitted from a referring hospital. Data collection included demographics and clinical parameters, and culture/susceptibility data. The primary objective was comparison of pathogens and clinical parameters in those with and without third-generation cephalosporin resistance. The secondary objectives included a comparison between those with and without ceftazidime exposure and identification of factors associated with resistance. Comparisons were made using χ2, Fisher exact tests, or Wilcoxon tests. A logistic regression was used to identify risk factors for resistance.ResultsOverall, 349 isolates, representing 215 patients, were included. The most common source was endotracheal (n = 192, 55.0%) and pathogens were E coli (31.8%) and P aeruginosa (29.2%). Overall, 12.3% (n = 43) were resistant and these were obtained after longer parenteral nutrition (PN), central line access, and antibiotic days versus susceptible isolates. Higher resistance was noted after ceftazidime exposure versus no exposure, 19.1% versus 6.6%. Each day of ceftazidime was associated with 13% greater odds of P aeruginosa resistance (adjusted odds ratio: 1.13 [95% confidence interval: 1.03-1.23]).Conclusion and RelevanceCeftazidime duration was associated with increased risk for P aeruginosa resistance. Additional studies are needed to confirm these findings.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-04-29T07:28:50Z
      DOI: 10.1177/10600280221088270
       
  • Effectiveness and Safety of Lower Dose of Rivaroxaban for Cancer-Related
           Venous Thromboembolism: A Retrospective Cohort Study

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      Authors: Chia-Ling Chang, Yi-Jei Lin, Chia-Chia Pan, Chun-Nan Kuo
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundPrimary and recurrent venous thromboembolism (VTE) commonly occur in patients with cancer. However, because of the National Health Insurance regulations, available dosage forms, and clinical conditions, the prescribed dose of rivaroxaban may not be consistent with its recommended dose.ObjectiveTo evaluate the 6-month recurrence rate of VTE and safety of rivaroxaban for patients with cancer.MethodsPatients with new cancer diagnosis or recurrence from 2014 to 2018 who initiated rivaroxaban for VTE from January 2015 to January 2019 were included. We set the rivaroxaban initiation date as the index date and followed up the patients for 180 days. We collected information regarding the starting and maintenance dose/frequency and the treatment duration. The efficacy outcome was the recurrence of VTE within 180 days. The safety outcome included the major bleeding rate and clinically relevant nonmajor bleeding (CRNMB) rate.ResultsApproximately, 46.2% of the 65 included patients received a standard starting dose, and 45% of patients received a maintenance dose above 15 mg (median: 23.9 and 13.1 mg per day, respectively). Two-thirds of the patients stopped treatment within 180 days. Recurrent VTE occurred in 2 (3.1%) patients within 6 months. The major bleeding rate was 7.7%, and the CRNMB rate was 3.1%.Conclusion and RelevanceThe 6-month recurrence rate of VTE and safety profile were similar between the lower and standard dose of rivaroxaban. This result may be applied to the institutions with dosage availability limited by formulary regulation and patients who cannot use full dose because of clinical considerations.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-04-25T11:42:33Z
      DOI: 10.1177/10600280221084418
       
  • Valproate: Not All Boxed Warnings Are Created Equal

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      Authors: Carolanne Wartman, Amy VandenBerg
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveValproate has undergone significant changes in labeling to the boxed warnings associated with it. This review will analyze evidence regarding the valproate-boxed warnings for teratogenicity, hepatotoxicity, and pancreatitis, with a particular emphasis on the fetal risk.Data SourcesA review of Pubmed, Cochrane Central Register, Google Scholar, manufacturer websites, and product labeling was performed from 1963 to February 2022, using the following search terms: valproate, valproic acid, depakote, teratogenicity, birth defects, fetal risk, hepatotoxicity, and pancreatitis. Relevant English-language studies and those conduced in humans were considered. Product labeling was also reviewed.Data SynthesisThere is a significant fetal risk following in utero valproate exposure (risk of malformation development: 8.6% in 360 women in North America). Current labeling in the United States recommends co-prescribing effective contraception for women of childbearing age. The risk of hepatotoxicity and pancreatitis is much lower in the general population (1/20 000 and 1/40 000 patients, respectively) compared with those patients with certain risk factors who are taking valproate (1/500).ConclusionsOverstated monitoring recommendations for the potential risk of hepatotoxicity and pancreatitis distracts from a much more common and severe risk of fetal harm. Clinicians must be diligent about discussing this risk with patients and documenting when this discussion occurs. Changes to the current recommendations for monitoring of the boxed warnings associated with valproate therapy should be considered, such as more stringent monitoring requirements for the inherent fetal risk. This could be accomplished through a Risk Evaluation and Mitigation Strategy program or through institution-based policies and procedures. In addition, monitoring recommendations for the risk of hepatotoxicity and pancreatitis should account for contributing risk factors.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-04-08T06:49:18Z
      DOI: 10.1177/10600280221085991
       
  • Rosuvastatin-Induced Dysarthria: An Unusual Drug Reaction

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      Authors: Romain Barus, Mathieu Jouvray, Sophie Gautier, Camille Potey
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-04-08T06:48:13Z
      DOI: 10.1177/10600280221085816
       
  • 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.
      ObjectivesThe purpose of this article is to summarize the results of major randomized controlled trials (RCTs) comparing clinical outcomes of critically ill patients treated with normal saline (NS) or balanced salt solutions (BSSs), address discordant results of these studies, and provide direction for future investigations.Data SourcesPubMed (2011 to January 2022) with bibliographies of retrieved articles searched for additional articles.Study Selection and Data ExtractionRCTs comparing NS and BSSs in critically ill adult patients.Data SynthesisRecently published large RCTs comparing NS with BSSs in heterogeneous populations of intensive care unit patients did not find significant differences in mortality, despite positive findings in some end points in prior RCTs. However, there were a number of methodologic issues common to the RCTs including: varying study designs and end points, clinician discretion for the majority or all treatments other than the primary intervention fluid, heterogeneous patients with varying levels of acuity, and lack of power to investigate potential subgroup differences. In addition, there were problematic issues related to blinding and use of nonstudy fluids.Relevance to Patient Care and Clinical PracticeIntravenous fluids are a mainstay of supportive care for critically ill patients. Similar to the so-called crystalloid-colloid debate, there has been a long-standing debate among critical care clinicians and researchers concerning the preferred crystalloid solution, NS versus one of the available BSSs.ConclusionsDespite the recent publication of large multicenter RCTs, the preferred resuscitation fluid, NS or a BSS, for critically ill patients is still open for debate, although the available investigations do provide some direction for clinicians and for future investigations.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-04-08T06:47:36Z
      DOI: 10.1177/10600280221084380
       
  • Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of
           Inflammatory Diseases

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      Authors: Shubha Bhat, Maitri Patel, Kristine Duly, David Choi
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveThe objective of the study was to review the pharmacologic and clinical profile of adalimumab-adbm (BI 695501), the first interchangeable biosimilar for treatment of inflammatory diseases.Data SourcesA PubMed search was conducted from inception to December 2021 using the keywords BI 695501 and adalimumab-adbm. Information was also obtained from published abstracts and package inserts.Study Selection and Data ExtractionPhase 1, 2 and 3 studies plus relevant literature on adalimumab-adbm pharmacologic and clinical profile were reviewed.Data Synthesis:Adalimumab-adbm approval was based on a series of phase 3 VOLTAIRE trials, which evaluated the biosimilar’s efficacy and safety in the treatment of moderate to severe Crohn’s disease, rheumatoid arthritis, and psoriasis. Interchangeability status was granted based on data from the VOLTAIRE-X trial. The VOLTAIRE and VOLTAIRE-X studies demonstrated comparable efficacy and safety between adalimumab-adbm and reference adalimumab. Common adverse events included infections and injection site reactions. Similar to reference adalimumab, adalimumab-adbm contains black box warnings related to serious infections and malignancy.Relevance to Patient Care and Clinical PracticeAdalimumab-adbm is the first interchangeable biosimilar to be approved for inflammatory diseases and has the potential to improve patient access to treatment while decreasing medication-related costs. However, it will not be commercially available for patient use until 2023 and its adoption into clinical practice may face potential barriers seen with other biosimilars.ConclusionAs an interchangeable biosimilar with comparable efficacy and safety to reference adalimumab, adalimumab-adbm is an important advance toward cost-effective management of inflammatory diseases.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-04-08T06:46:21Z
      DOI: 10.1177/10600280221082196
       
  • Why Is Oral Phenylephrine on the Market After Compelling Evidence of Its
           Ineffectiveness as a Decongestant'

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      Authors: Randy C. Hatton, Leslie Hendeles
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Ineffective over-the-counter (OTC) drugs should be removed from the US market. Despite solid research showing that oral phenylephrine is ineffective as a decongestant, the US Food and Drug Administration has failed to respond to a 2015 citizen’s petition to remove it from the OTC nasal decongestant monograph. Other examples of scientifically proven ineffective OTC medications include guaifenesin as an expectorant, dextromethorphan as a cough suppressant, and chlorpheniramine for cold symptoms.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-03-26T06:18:17Z
      DOI: 10.1177/10600280221081526
       
  • Ceftaroline: Systematic Review of Clinical Uses and Emerging Drug
           Resistance

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      Authors: Getahun Abate, Grace Wang, Jared Frisby
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo assess the success rates of off-label uses of ceftaroline for infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and evaluate emerging ceftaroline resistance.Data SourcesWe queried PubMed/MEDLINE, with the search term “Ceftaroline.” Articles were restricted to the English language and year of publication (January 1, 2009-January 31, 2022).Study Selection and Data ExtractionClinical trials, observational studies, and case reports that reported efficacy, safety, pharmacokinetics, use in MRSA infections other than acute bacterial skin infection and community-acquired pneumonia, and ceftaroline resistance were selected.Data SynthesisThe search pooled 103 publications and all abstracts were reviewed. Forty-six articles that reported efficacy, safety, pharmacokinetics, or off-label use in multiple patients and 7 articles on ceftaroline resistance are used in this review. Ceftaroline has been approved for treatment of acute skin/soft tissue infection and community-acquired pneumonia. Ceftaroline’s efficacy in off-label infections ranged from 66.7% to 87.3% depending on the types of infection. There were 14 documented cases of ceftaroline resistance associated with PBP2a changes.Relevance to Patient Care and Clinical practiceCase series and observational studies have documented success with ceftaroline alone or in combination with vancomycin or daptomycin for treatment of MRSA bone and joint, endovascular, diabetic foot infections, and bacteremia from other causes.ConclusionDespite the lack of randomized controlled trials, ceftaroline is used as salvage therapy for different MRSA infections. The data from case series and observational studies are promising but ceftaroline should be used judiciously as ceftaroline-resistant MRSA begin to emerge.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-03-18T08:56:19Z
      DOI: 10.1177/10600280221082326
       
  • Prior Authorization for Ustekinumab Dose Escalation Negatively Affects
           Outcomes in Patients With Inflammatory Bowel Disease

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      Authors: David K. Choi, Archariya Puangampai, David T. Rubin
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-03-18T08:53:06Z
      DOI: 10.1177/10600280221080986
       
  • Retrospective Evaluation of Intrapleural Tissue Plasminogen Activator With
           or Without Dornase Alfa for the Treatment of Traumatic Retained
           Hemothorax: A 6-Year Experience

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      Authors: Christopher Francis Janowak, Bradley Robert Becker, Carolyn Dosen Philpott, Amy Teres Makley, Eric William Mueller, Christopher Allen Droege, Molly Elizabeth Droege
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Intrapleural fibrinolytic instillation is second-line treatment for retained hemothorax. Dornase alfa (DNase) has demonstrated efficacy in parapneumonic effusion, but the lack of deoxyribonucleoproteins limits direct extrapolation to traumatic retained hemothorax treatment.Objective:This study evaluated the effectiveness of intrapleural tissue plasminogen activator (tPA) with and without DNase in the treatment of retained traumatic hemothorax.Methods:This retrospective cohort study included patients aged 16 years and older admitted to a level 1 trauma center from January 2013 through July 2019 with retained hemothorax and one or more intrapleural tPA instillations. Exclusion criteria were tPA for other indications or concomitant empyema. The primary endpoint was treatment failure defined as the need for operative intervention.Results:Fifty patients were included (tPA alone: 28; tPA with DNase: 22). Baseline characteristics were similar between groups, including time to diagnosis (6.5 [interquartile range (IQR), 4-15.5] days vs 6 [IQR, 6.3-10.8] days, P = 0.52). Median tPA dose per treatment (6 [IQR, 6-6.4] mg vs 10 [IQR, 8.4-10] mg, P < 0.001) and cumulative tPA (18 [IQR, 6.5-24] mg vs 30 [IQR, 29.5-40], P < 0.001) dose were significantly lower in the tPA alone group. Treatment failure was similar between groups. Chest tube output, retained hemothorax reduction, and bleeding incidences were similar between groups. Multivariate logistic regression demonstrated no significant risk factors for treatment failure.Conclusions and Relevance:Dornase alfa added to tPA may not reduce the need for operation to treat retained hemothorax. Further studies should be directed at optimal tPA dose determination and economic impact of inappropriate DNase use.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-21T05:03:43Z
      DOI: 10.1177/10600280221077383
       
  • Symptomatic Relief by Bleomycin Pericardial Adhesion in a Patient With
           Esophageal Carcinoma and Pericardial Effusion

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      Authors: Mei Yamaguchi, Hideki Sugita, Satoshi Mastukuma, Yutaro Kubota, Shuuichi Nawata
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-18T12:40:35Z
      DOI: 10.1177/10600280221079287
       
  • Elevated Tacrolimus Levels at Time of Diagnosis of COVID-19 Compared to
           Baseline Among Hospitalized Organ Transplant Recipients

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      Authors: Krista Mecadon, Anna Hardesty, Kendra Vieira, Ralph Rogers, Basma Merhi, Adena J. Osband, George Bayliss; MD, Reginald Gohh, Paul Morrissey, Dimitrios Farmakiotis
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:The effect of COVID-19 on immunosuppressant drug levels in organ transplant recipients (OTRs) has not been adequately studied.Objective:To study the effect of COVID-19 on tacrolimus trough levels (primary outcome) in OTRs and the association of the later with acute kidney injury, bacterial infection, and oxygen requirements.Methods:We studied adult (>18-year-old) hospitalized OTRs with COVID-19, who were receiving tacrolimus between 3/1 and 12/16/2020.Results:Among 30 OTRs, 67% were men, 90% had a kidney transplant. Median age was 60.5 (interquartile range [IQR]: 45-68) years, median time from transplant 36 (IQR: 20-84) months. Tacrolimus troughs were higher on admission for COVID-19 than baseline (average over 6 months prior) (P = .001). Eighteen patients (60%) had admission tacrolimus trough>10, 5 (17%)>20 ng/mL. Patients with diarrhea had borderline higher tacrolimus troughs, compared to those without diarrhea (P = .09). Organ transplant recipients with a tacrolimus trough>10 ng/mL were more likely to have elevated aspartate aminotransferase on admission (P = .01) and require supplemental oxygen. (P = .026).Conclusion and Relevance:Tacrolimus trough levels were elevated in most OTRs with COVID-19 at the time of hospital admission, compared to baseline. Potential mechanisms are diarrhea and hepatic involvement in COVID-19. In OTRs with COVID-19, including outpatients, immunosuppressant drug levels should be closely followed; management of immunosuppression should be individualized.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-18T12:39:29Z
      DOI: 10.1177/10600280221078983
       
  • Thrombocytopenia Associated With Teicoplanin Use: A Retrospective
           Observational Study

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      Authors: Reem Elajez, Ibtihal Abdallah, Dana Bakdach, Eman Shaat, Enas Osman, Mona Baraka, Rania Gergess, Rehab Abdalla, Eman Al Hamoud, Muna Al Bakri, Hussam Al Soub
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Contradictory studies reporting vast heterogeneity in the teicoplanin-induced thrombocytopenia (TIT) incidence exist.Objective:To identify the incidence of TIT associated with teicoplanin dosing range (6–12 mg/kg/dose) and the risk factors of TIT.Methods:This retrospective observational study included adult patients who received teicoplanin for ≥3 consecutive days over a period of 3.5 years. Thrombocytopenia was defined as a platelet count of
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-18T12:38:18Z
      DOI: 10.1177/10600280221078123
       
  • Observed Apixaban Anti-Xa Levels in Obese Patients

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      Authors: Weston Harkness, Olivia Pipitone, Jacqueline Joss, Michael Schiedler, Santon Shagavah, Ryan Moore, Jeff Hsing
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Recent guidelines suggest that, for venous thromboembolism (VTE), standard doses of apixaban are appropriate in patients with body mass index (BMI)>40 kg/m2 or>120 kg. Atrial fibrillation (AF) is excluded from this recommendation.Objective:The goals of our study were to measure and describe anti-Xa levels of patients with a BMI ≥40 kg/m2 and/or a weight ≥120 kg with a clinical indication of AF or VTE who were treated with apixaban, and to determine whether BMI or weight are associated with anti-Xa levels in this population.MethodsWe conducted an observational cohort study at a single health care system in Oregon, USA. Patients meeting enrollment criteria were recruited and had peak and trough apixaban anti-Xa levels drawn.ResultsOf 55 patients enrolled, 5 (9%) had peak anti-Xa levels below the reference range and 3 (6%) had trough anti-Xa levels below the reference range. BMI did not significantly correlate with peak or trough anti-Xa levels (r = −0.10, p = 0.45 and r = −0.14, p = 0.31). Weight had a moderate, negative correlation with peak anti-Xa levels (r = −0.42, p = 0.002) and a weak, negative correlation with trough anti-Xa levels (r = −0.32, p = 0.02).Conclusions and RelevanceThis study provides evidence that anti-Xa levels among obese patients are not substantially different from patients with nomral BMI and weight. This supports recent ISTH guidance for standard dosing of apixaban for VTE patients with BMI>40 kg/m2 or weight>120 kg and provides additional evidence that the standard dosing may also be appropriate in patients with AF.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-16T04:58:09Z
      DOI: 10.1177/10600280221077158
       
  • Economic Impact of Ambulatory Clinical Pharmacists in an Advanced Heart
           Failure Clinic

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      Authors: Kazuhiko Kido, Bailey M. Colvin, Rachael Broscious, Sydney Bongiorni, George Sokos, Khalid M. Kamal
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Clinical pharmacists play pivotal roles in multidisciplinary heart failure (HF) teams through the management of HF pharmacotherapy, but no study has examined the economic impact of HF ambulatory clinical pharmacists in an advanced HF clinic.Objective:The objective of the study was to evaluate the economic impact of HF ambulatory clinical pharmacist interventions in an advanced HF clinic using a cost-benefit analysis.Methods:This prospective observational study detailed HF ambulatory clinical pharmacist interventions over 6 months in an advanced HF clinic in a single-center tertiary teaching hospital. The economic impact of the interventions was estimated based on the indirect cost savings with pharmacist interventions and direct cost savings recommendations. A cost-benefit analysis was performed to assess the cost of delivering the interventions compared with the benefits generated by clinical pharmacists. Results were reported as a benefit-cost ratio and net benefits.Results:HF ambulatory clinical pharmacists made a total of 2,361 provider-accepted interventions over 6 months. Overall, the 3 most common intervention types were medication reconciliation (28.7%), dose change (20.8%), and addition of medication (12.3%). Anticoagulation (21.2%) was the most common intervened class of medication, followed by sodium-glucose cotransporter-2 inhibitor (12.3%) and angiotensin receptor neprilysin inhibitor (9.2%). The total net benefits were $55,553.24 over 6 months and the benefit-cost ratio was 1.55.Conclusion and Relevance:The addition of cardiology clinical pharmacists to an advanced HF clinic may be financially justified and cost-beneficial.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-16T04:55:03Z
      DOI: 10.1177/10600280221075755
       
  • Voclosporin: A Novel Calcineurin Inhibitor for the Treatment of Lupus
           Nephritis

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      Authors: Ann C. McArn, Alexander R. Nixon, Katherine L. Jarrell
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To describe the safety, efficacy, and potential role in therapy of voclosporin, an oral calcineurin inhibitor approved by the Food and Drug Administration (FDA) in January 2021 as an adjunct treatment for lupus nephritis.Data Sources:A literature search was conducted using PubMed with the following terms: voclosporin, Lupkynis, and lupus nephritis (January 1, 2010, to December 1, 2021). FDA product labeling was also reviewed for pertinent data sources.Study Selection and Data Extraction:All articles were considered for inclusion. English-language articles selected included preclinical and clinical studies examining the pharmacokinetics, efficacy, and/or safety of voclosporin.Data Synthesis:Voclosporin has been studied as an adjunct immunosuppressive agent in patients with lupus nephritis. Drug design allows for a more predictable pharmacokinetic profile than other calcineurin inhibitors. Data suggest that adding this newly approved calcineurin inhibitor to a regimen of mycophenolate mofetil and corticosteroids produces promising therapeutic results. As such, voclosporin has been approved for use in patients with active lupus nephritis who are maintained on immunosuppressive therapy with mycophenolate mofetil and a corticosteroid.Relevance to Patient Care and Clinical Practice:Voclosporin may be a favorable calcineurin inhibitor in patients with lupus nephritis, due to a predictable pharmacokinetic profile. This allows for decreased therapeutic drug monitoring and suggests a favorable adverse effect profile. However, cost remains a consideration with this new agent.Conclusions:Current available data suggest that voclosporin is a promising adjunct treatment option for patients with active lupus nephritis who are maintained on mycophenolate mofetil and a corticosteroid.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-16T04:53:43Z
      DOI: 10.1177/10600280221075331
       
  • Safety and Efficacy of an Intensive Care Insulin Infusion Protocol
           Targeting a Blood Glucose of 140 to 180 mg/dL

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      Authors: Michelle M. Chatley, Michael R. Thuyns
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundDespite multiple guideline recommendations of a goal blood glucose of 140 to 180 mg/dL in critically ill patients, no insulin infusion protocols (IIPs) targeting this range have been validated and published in the literature.ObjectiveThe purpose of this study is to determine the safety and efficacy of an IIP targeting a blood glucose of 140 to 180 mg/dL in critically ill patients, with the ultimate goal of validating such a protocol.MethodsThis retrospective chart review uses data of critically ill patients admitted from August 2018 to December 2018. Patient data from August 2017 to December 2017 served as a historical comparator to further assess safety outcomes. Percent of blood glucose readings within goal was the primary outcome measurement. Relevant clinical variables, insulin requirements, hypoglycemic events, and protocol adherence were also recorded.ResultsA total of 88 insulin infusions were included in analysis, 34 of which served as a historical comparator. In the IIP targeting a blood glucose 140 to 180 mg/dL, once blood glucose levels decreased below 180 mg/dL, 54% of blood glucose readings were within goal (140-180 mg/dL) and 73% of blood glucose readings were within a “clinically acceptable” range (110-180 mg/dL). The number of hypoglycemic events decreased from 70 in the historical comparator group to 4 in the current IIP (P < .0001).Conclusion and relevanceThis IIP is both safe and effective at targeting a blood glucose of 140 to 180 mg/dL and could be used at other institutions to achieve satisfactory glycemic control.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-16T04:48:40Z
      DOI: 10.1177/10600280221074683
       
  • Efficacy of Liposomal Bupivacaine for Sternotomy Pain After Cardiac
           Surgery: A Retrospective Analysis

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      Authors: Janki Patel, Ryan Medas, Julianne Donnelly, Brandon Mullins
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Multimodal analgesia is a cornerstone of postoperative pain management. Different formulations of local anesthetics are available. Data to support these treatment options are limited.Objective:To determine the efficacy of liposomal bupivacaine compared with bupivacaine or ropivacaine in patients undergoing sternotomy for coronary artery bypass graft (CABG) and/or valve surgery.Methods:Single-center, retrospective, observational study at a community teaching hospital. Patients included were 18 years of age or older undergoing CABG and/or valve surgery via median sternotomy and received either liposomal bupivacaine or an active comparator. The primary outcome was opioid utilization in morphine milligram equivalent (MME) from 0 to 72 hours.Results:A total of 376 patients were included, 223 in the liposomal bupivacaine arm and 153 in the active comparator arm. There was no difference in the MME use from 0 to 72 hours among patients in the liposomal bupivacaine group compared with the comparator group (114.2 mg [75.55] vs 107.6 mg [68.4], P = 0.38). After Bonferroni correction, there was no difference in pain scores at individual time points. At 24- and 48-hour post-op, pain scores were higher with liposomal bupivacaine at 4.4 (2.7) vs 3.5 (2.8) (P = 0.01) and 3.1 (2.9) vs 2.4 (2.6) (P = 0.02).Conclusion and Relevance:Based on these findings and previous studies, liposomal bupivacaine should not be routinely used for CABG and/or valve surgery through a median sternotomy given lack of superiority. This helps inform surgical practice to the role of anesthetics as part of the multimodal analgesia regimen.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-16T04:44:58Z
      DOI: 10.1177/10600280211067221
       
  • Outcomes and Management of Immune Checkpoint Inhibitor–Induced
           Hypothyroidism: A Retrospective Analysis

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      Authors: Allison L. Phillips, David J. Reeves
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Immune checkpoint inhibitors (ICIs) used in cancer treatment cause immune-related adverse effects (irAEs), including thyroiditis leading to hypothyroidism. The management and outcomes of this irAE are not well established.Objective:The purpose of this analysis is to describe the onset, management, and outcomes of patients experiencing hypothyroidism from ICI.Methods:A retrospective study was conducted of adults receiving ICI therapy at a community cancer center between January 1, 2017, and February 1, 2020. The primary endpoint was to describe onset (timing) of hypothyroidism (thyroid-stimulating hormone [TSH]> 10 µIU/mL). Secondary outcomes included describing hypothyroidism symptoms and levothyroxine use, time to documented disease progression, and occurrence of additional adverse effects (AEs).Results:Of the 200 patients included in the study, 19% developed clinical hypothyroidism (TSH> 10 µIU/mL, or required initiation of or dose increase in levothyroxine). Median time to TSH higher than 10 µIU/mL was 13.3 weeks and symptoms of hypothyroidism occurred in 34% of patients developing clinical hypothyroidism. The median final daily levothyroxine dose was 88 mcg (0.88 mcg/kg). Time to disease progression was longer in those with clinical hypothyroidism (27.4 months vs. 6.8 months, respectively, P = .015). Additional AEs occurred in 68% of those developing hypothyroidism versus 49% without hypothyroidism (P = .029).Conclusion and Relevance:Patients with clinical hypothyroidism during ICI treatment may have improved cancer outcomes, but they also are more likely to develop other AEs. Patients requiring thyroid replacement therapy with levothyroxine may benefit from a starting dose between 50 and 100 mcg/day, approximately 0.88 mcg/kg/day.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-16T04:43:39Z
      DOI: 10.1177/10600280211073323
       
  • Ibuprofen-Associated Hypokalemia and Metabolic Acidosis: Systematic
           Literature Review

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      Authors: Anca M. Man, Arianna Piffer, Giacomo D. Simonetti, Martin Scoglio, Pietro B. Faré, Sebastiano A. G. Lava, Mario G. Bianchetti, Gregorio P. Milani
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:Ibuprofen is a widely used nonsteroidal anti-inflammatory drug, which has been occasionally associated with hypokalemia and metabolic acidosis. The objective of this report is to analyze the literature on this issue and to address the underlying pathophysiology.Data Sources:Excerpta Medica, the National Library of Medicine, and Web of Science were searched from inception to July 16, 2021.Study Selection and Data Extraction:Papers reporting individually documented humans on ibuprofen with hypokalemia, acidosis, or both were retained. Data were extracted using a checklist.Data synthesis:For the final analysis, we evaluated 41 reports describing 50 cases (26 males and 24 females; 36 adults and 14 children) with often profound hypokalemia, acidosis, or both after ingestion of ibuprofen. Twenty-six cases were acute and 24 long term. Hypokalemia and acidosis occurred not only after ingestion of very high doses but also after ingestion of moderately high or even normal doses of ibuprofen. Laboratory values consistent with an excessive urinary potassium excretion or an altered urinary acidification were often disclosed in most cases. Discontinuation of ibuprofen resulted in a resolution of hypokalemia and acidosis within days in 47 cases. The course was lethal in 3 cases.Relevance to Patient Care and Clinical Practice:This review highlights potentially fatal side effects of ibuprofen and can help doctors who are confronted with such a situation.Conclusions:These data highlight the potential of ibuprofen to occasionally induce hypokalemia and acidosis of renal origin. Discontinuation of ibuprofen results in a resolution within days.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-09T05:23:06Z
      DOI: 10.1177/10600280221075362
       
  • Abemaciclib: The First FDA-Approved CDK4/6 Inhibitor for the Adjuvant
           Treatment of HR+ HER2− Early Breast Cancer

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      Authors: Farah Raheem, Henry Ofori, Lacey Simpson, Vishal Shah
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To review the new indication of cyclin-dependent kinase (CDK4/6) inhibitor abemaciclib for the adjuvant treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2−), axillary lymph node (LN) positive early breast cancer (EBC) at high risk of recurrence and a Ki-67 ≥20%.Data Sources:A literature search was performed through PubMed, ClinicalTrials.gov, and Food and Drug Administration (FDA) website (February 1, 2018, to December 23, 2021) to identify relevant information.Study Selection and Data Extraction:Human and animal studies related to pharmacology, pharmacokinetics, efficacy, and safety of abemaciclib were identified.Data Synthesis:Addition of abemaciclib to standard of care endocrine therapy (ET) for patients with high-risk clinicopathologic features and Ki-67 ≥20% demonstrated 30% reduction in the risk of developing invasive disease and distant recurrence. At 15.5 months, abemaciclib + ET demonstrated a significant improvement in invasive disease-free survival (IDFS) vs ET alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.60-0.93, P = 0.01). At 27 months, IDFS benefit was maintained (HR, 0.70; 95% CI, 0.59-0.82, P < 0.0001). Diarrhea occurred in more than 80% of patients in the abemaciclib arm.Relevance to Patient Care and Clinical Practice:This review describes the clinical applicability of adjuvant abemaciclib for patients with HR+, HER2− EBC at high risk for recurrence.Conclusion:Adjuvant abemaciclib significantly reduces the risk for early development of invasive disease and distant recurrence in patients with HR+, HER2− node positive EBC. Longer follow-up is needed to determine the impact of adjuvant abemaciclib on late disease recurrence and survival outcomes.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-09T05:21:03Z
      DOI: 10.1177/10600280211073322
       
  • Intermittent Versus Continuous Infusion Dosing of Intravenous Proton Pump
           Inhibitors for Upper Gastrointestinal Bleeding

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      Authors: Thomas Leung, Sonya Kedzior, Kerry Moore, Jesse Bierman, Zlatan Coralic
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Proton pump inhibitor (PPI) continuous infusions or intermittent boluses are used for the treatment of upper gastrointestinal bleeding (UGIB). Intermittent boluses are easier to give and are of lower cost without affecting clinical outcomes.Objective:To compare the rate of rebleeding between intermittent bolus and continuous infusion PPI therapy.Methods:We performed a retrospective, multicenter review of patients with UGIB receiving either continuous or intermittent PPI therapy. During the study period, due to drug and supply shortages, each institution implemented policies preferring intermittent PPI bolus therapy. We performed bivariate and multivariable comparisons of the 2 treatment strategies, with the primary outcome of interest being incidence of rebleeding. Additional variables of interest included intensive care unit (ICU) and hospital lengths of stay, discharge disposition, and in-hospital mortality.Results:Compared with intermittent bolus dosing (n = 209), patients receiving continuous infusion PPI (n = 237) were associated with a higher rate of rebleeding (33.8% vs 23.0%; P = 0.012); however, no difference was detected in multivariable analysis: adjusted odds ratio, 1.50 (95% confidence interval, 0.91-2.50). There was no difference in median hospital or ICU length of stay, discharge disposition, or in-hospital mortality. Correlatively, patients receiving continuous infusion therapy were more likely to have liver disease (29.1% vs 20.1%; P = 0.028), alcohol use disorder (28.3% vs 16.3.%; P = 0.003), history of lower gastrointestinal bleeding (6.4% vs 1.9%; P = 0.021), variceal bleeding (6.3 vs 2.4%, P = 0.045), and be admitted to the ICU (65.0% vs 32.5%, P = 0.00).Conclusions:Introduction of intermittent PPI bolus UGIB treatment via change in hospital policy was not associated with higher rates of rebleeding. However, continuous PPI therapy may have been perceived as more effective as it was used more commonly in high-risk patients.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-09T05:19:06Z
      DOI: 10.1177/10600280211073936
       
  • COVID-19 Vaccine-Associated Pericarditis

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      Authors: Giuseppe Famularo, Maria Cristina Macciomei
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-08T09:44:20Z
      DOI: 10.1177/10600280211073970
       
  • Determinants of Vancomycin Trough Concentration in Patients Receiving
           Continuous Veno-Venous Hemodialysis

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      Authors: Nicholas J. Quinn, Gretchen L. Sacha, Matthew R. Wanek, Jason Yerke, Pavithra Srinivas, Benjamin Hohlfelder
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Vancomycin pharmacokinetics are altered in the critically ill and are further distorted by renal replacement therapy. Limited literature is available evaluating vancomycin dosing in continuous veno-venous hemodialysis (CVVHD).Objective:The goal of this analysis was to identify factors that affect vancomycin trough concentration in patients on CVVHD and to determine an appropriate dosing strategy.Methods:This was a single-center, retrospective cohort study of adult inpatients admitted to the Cleveland Clinic from May 2016-December 2017. Patients in the intensive care unit who received ≥ 2 doses of vancomycin during CVVHD were included. Patients with interruptions of CVVHD inappropriately timed troughs, a change in dialysate rate, and those who received different vancomycin dosages were excluded. Multivariable linear regression including age, sex, weight, Sequential Organ Failure Assessment score, albumin, 24-hour urine output (UOP), dialysate rate, filter type, and vancomycin dose was run to determine predictors of vancomycin concentration.Results:A total of 160 patients were included. The median vancomycin dose was 12.6 mg/kg with a trough of 24.6 mcg/mL. Weight, 24-hour UOP, vancomycin dose (mg/kg), and dialysate rate (mL/kg/h) were all determined to be independent predictors of vancomycin trough level. Patients who received 10 mg/kg (N=142), the median trough was 25.5 mcg/mL, with 47% being therapeutic.Conclusion and Relevance:Vancomycin dose, dialysate rate, UOP, and weight are independently associated with vancomycin trough concentration. In CVVHD patients, vancomycin dosed at 10 mg/kg every 24 hours may be an appropriate recommendation.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-08T09:42:59Z
      DOI: 10.1177/10600280211073370
       
  • Weight Changes With Integrase Strand Transfer Inhibitor Therapy in the
           Management of HIV Infection: A Systematic Review

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      Authors: E.Kelly Hester, Sage Greenlee, Spencer H. Durham
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To describe weight changes with integrase strand transfer inhibitor (INSTI) therapy.Data Sources:A literature search was performed (through December 15, 2021) using the PubMed and CINAHL databases using the search terms: “integrase inhibitors,” “integrase strand transfer inhibitors,” and “weight.”Study Selection and Data Extraction:Studies were included that provided relevant information on weight or body mass index (BMI) changes on INSTI therapy. Controlled or observational studies comparing different INSTI therapies or compared INSTI therapy to another class of antiretroviral therapy were included.Data Synthesis:Forty-three articles met criteria for inclusion, and data are presented. Although some trials have observed similar weight gains between INSTI, protease inhibitor, and non-nucleoside inhibitor therapies, the increase appears to be greater with INSTI therapy, particularly during initiation of therapy. Risk factors for weight gain with INSTI therapy include female gender, lower CD4 count, and combined use of tenofovir alafenamide. Within the INSTI class, dolutegravir and bictegravir appear to have the greatest propensity for weight gain.Relevance to Patient Care and Clinical Practice:INSTI-based therapies are the preferred initial management of HIV infection. Discerning the factors contributing to weight changes on INSTI therapy and risks of associated health-related outcomes is important to both the management of weight gain and HIV medical management.Conclusions:Within the INSTI class, dolutegravir and bictegravir may be associated with the greatest risk for weight gain particularly when combined with tenofovir alafenamide. Further research is needed to determine mechanisms for observed weight changes and any contributions to clinically significant metabolic and cardiovascular adverse outcomes associated with INSTI therapy.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-08T09:41:30Z
      DOI: 10.1177/10600280211073321
       
  • Tazarotene 0.045% Lotion: A Novel Retinoid Formulation

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      Authors: Lindsey A. Mohney, Rohan Singh, Steven R. Feldman
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveThe aim of this study is to review the available data on efficacy and tolerability of tazarotene 0.045% lotion.Data SourcesA literature search of MEDLINE (PubMed) and EMBASE databases was completed in November 2021.Study Selection and Data ExtractionArticles that discussed efficacy, tolerability, and pharmacology of tazarotene 0.045% lotion, written in English and published before mid-November 2021, were assessed.Data SynthesisIn two, 12-week phase III clinical trials, tazarotene 0.045% lotion had higher rates of treatment success (study 1: 25.5% and study 2: 29.6%) than individuals who received the vehicle (study 1: 13.0% and study 2: 17.3%) (both Ps < 0.001). Participants treated with tazarotene 0.045% lotion had greater least squares mean reduction in inflammatory (study 1: 55.5% and study 2: 59.5%) and noninflammatory (study 1: 51.4% and study 2: 60%) acne lesions when compared with vehicle (inflammatory acne lesions, study 1: 45.7% and study 2:49%; noninflammatory acne lesions, study 1: 41.5% and study 2: 41.6%) (P < 0.001 for studies 1 and 2). Tazarotene 0.045% lotion was well tolerated.Relevance to Patient Care and Clinical PracticeRetinoids are first-line therapy in the treatment of acne vulgaris. However, many patients experience cutaneous irritation, which can decrease patient adherence and efficacy. Tazarotene 0.045% lotion is the first retinoid to utilize polymeric emulsion technology (PET) to efficiently distribute the medication across the skin, decreasing adverse effects while maintaining efficacy.ConclusionsTazarotene 0.045% lotion is an effective and well-tolerated retinoid recently approved by the US Food and Drug Administration (FDA) for treating acne vulgaris in individuals 9 years of age and older.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-03T10:23:14Z
      DOI: 10.1177/10600280211072155
       
  • Pharmacists Have the Stats but No Provider Status: Now May Be Our Moment

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      Authors: C. Michael White
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-02-02T12:02:15Z
      DOI: 10.1177/10600280211036160
       
  • Antiplatelet Use in Ischemic Stroke

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      Authors: Marharyta Kamarova, Sheharyar Baig, Hamish Patel, Kimberley Monks, Mohammed Wasay, Ali Ali, Jessica Redgrave, Arshad Majid, Simon M. Bell
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:A literature review of antiplatelet agents for primary and secondary stroke prevention, including mechanism of action, cost, and reasons for lack of benefit.Data sources:Articles were gathered from MEDLINE, Cochrane Reviews, and PubMed databases (1980-2021). Abstracts from scientific meetings were considered. Search terms included ischemic stroke, aspirin, clopidogrel, dipyridamole, ticagrelor, cilostazol, prasugrel, glycoprotein IIb/IIIa inhibitors.Study selection and data extraction:English-language original and review articles were evaluated. Guidelines from multiple countries were reviewed. Articles were evaluated independently by 2 authors.Data synthesis:An abundance of evidence supports aspirin and clopidogrel use for secondary stroke prevention. In the acute phase (first 21 days postinitial stroke), these medications have higher efficacy for preventing further stroke when combined, but long-term combination therapy is associated with higher hemorrhage rates. Antiplatelet treatment failure is influenced by poor adherence and genetic polymorphisms. Antiplatelet agents such as cilostazol may provide extra benefit over clopidogrel and aspirin, in certain racial groups, but further research in more diverse ethnic populations is needed.Relevance to patient care and clinical practice:This review presents the data available on the use of different antiplatelet agents poststroke. Dual therapy, recurrence after initiation of secondary preventative therapy, and areas for future research are discussed.Conclusions:Although good evidence exists for the use of certain antiplatelet agents postischemic stroke, there are considerable opportunities for future research to investigate personalized therapies. These include screening patients for platelet polymorphisms that confer antiplatelet resistance and for randomized trials including more racially diverse populations.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-29T08:18:51Z
      DOI: 10.1177/10600280211073009
       
  • A Multidisciplinary Educational Approach to Anticoagulation Management for
           a Percutaneous Endovascular Mechanical Circulatory Support Device

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      Authors: Patrick H. Lee, Lauren Schwaner, Gillian Taglieri, Caitlin F. Mullins, Lynne M. Sylvia
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundAnticoagulation (AC) management of the Impella varies considerably among treatment centers. Published data regarding the management of complications including heparin-induced thrombocytopenia, bleeding and thrombosis are limited.ObjectiveA multidisciplinary team was assembled to 1) identify baseline knowledge of nurses and pharmacists involved in Impella anticoagulation management; 2) develop an educational tool specific to Impella anticoagulation; 3) reassess knowledge following implementation of the tool.MethodsA team consisting of pharmacists, nurses and a physician developed surveys that were subsequently distributed to 28 nurses and 17 pharmacists. Survey questions measured knowledge in 4 areas of anticoagulation management: product selection, administration, monitoring and therapeutic recommendation. A pocket card containing flow diagrams for Impella anticoagulation management was developed. Following distribution of the card and education on its application, surveys were redistributed to measure the change in knowledge.ResultsThe frequency (%) of correct answers for all survey questions for both pharmacists and nurses significantly increased from 38% to 84% (p < 0.00001) and 63% to 93% (p < 0.00001), respectively. Substantial increases in the frequency of correct answers in the majority of question categories were observed for both pharmacists and nurses postintervention.Conclusion and RelevanceUsing a multidisciplinary approach, an institution-specific pocket card addressing the complexities of Impella anticoagulation was developed. Following dissemination of the card and education on its application, improved knowledge across the scope of Impella anticoagulation management was observed in both pharmacists and nurses.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-29T08:17:01Z
      DOI: 10.1177/10600280211071072
       
  • Impact of Ketamine on Analgosedative Consumption in Critically Ill
           Patients: A Systematic Review and Meta-Analysis

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      Authors: Katalina Chan, Lisa D. Burry, Christopher Tse, Hannah Wunsch, Charmaine De Castro, David R. Williamson
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:The aim of this study was to synthesize evidence available on continuous infusion ketamine versus nonketamine regimens for analgosedation in critically ill patients.Data sourcesA search of MEDLINE, EMBASE, CINAHL, CDSR, and ClinicalTrials.gov was performed from database establishment to November 2021 using the following search terms: critical care, ICU, ketamine, sedation, and anesthesia. All studies included the primary outcome of interest: daily opioid and/or sedative consumption.Study selection and data extractionRelevant human studies were considered. Randomized controlled trials (RCT), quasi-experimental studies, and observational cohort studies were eligible. Two reviewers independently screened articles, extracted data, and appraised studies using the Cochrane RoB and ROBINS-I tools.Data synthesisA total of 13 RCTs, 5 retrospective, and 1 prospective cohort study were included (2255 participants). The primary analysis of six RCTs demonstrated reduced opioid consumption with ketamine regimens (n = 494 participants, −13.19 µg kg−1 h−1 morphine equivalents, 95% CI −22.10 to −4.28, P = 0.004). No significant difference was observed in sedative consumption, duration of mechanical ventilation (MV), ICU or hospital length of stay (LOS), intracranial pressure, and mortality. Small sample size of studies may have limited ability to detect true differences between groups.Relevance to patient care and clinical practiceThis meta-analysis examining ketamine use in critically ill patients is the first restricting analysis to RCTs and includes up-to-date publication of trials. Findings may guide clinicians in consideration and dosing of ketamine for multimodal analgosedation.ConclusionResults suggest ketamine as an adjunct analgosedative has the potential to reduce opioid exposure in postoperative and MV patients in the ICU. More RCTs are required before recommending routine use of ketamine in select populations.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-27T05:21:51Z
      DOI: 10.1177/10600280211069617
       
  • A Scoping Review Evaluating the Effect of SGLT-2 Inhibitors on Insulin
           Dose Requirements in Insulin-Dependent Patients With Type 2 Diabetes

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      Authors: Morgan K. Moulton, Blake R. Johnson, Devin L. Lavender, Sharmon P. Osae, Beth Bryles Phillips, Ian Thomas, Rebecca H. Stone
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveAssess evidence describing the effect of Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors on total daily insulin (TDI) requirements in insulin-dependent patients with type 2 diabetes.Data sourcesA scoping review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Protocols and Scoping Reviews (PRISMA-ScR) guidelines. The search was conducted in PubMed; citation mapping was completed in Web of Science. Filters for human studies, English language, and a publication date, from January 1, 2005 to April 12, 2021, were applied.Study selection and data extractionStudies assessing insulin dose requirements with concurrent use of an SGLT2 inhibitor for patients with type 2 diabetes were included.Data synthesisSixteen studies were included and demonstrated that addition of an SGLT2 inhibitor typically reduced TDI requirements. Insulin reductions were often statistically significant, occurring in studies evaluating (1) within subjects who received SGLT2 inhibitors, and (2) between subjects receiving SGLT2 inhibitors versus placebo. Compared with placebo, insulin dose reduction ranged from −0.72 to −19.2 units. However, studies were relatively small, not designed to assess TDI change, and some utilized fixed dose insulin protocols or empiric insulin dose reductions.ConclusionsLowering insulin requirements may have benefits, such as decreased hypoglycemia risk, insulin resistance, and cost. Addition of an SGLT2 inhibitor may modestly reduce TDI requirements for patients with type 2 diabetes. Evidence indicating SGLT2 inhibitor use reduces TDI may lead to additional implementation in practice and inform future research. Further research is needed to clarify insulin type (i.e., basal or prandial) and degree of TDI reduction expected with addition of an SGLT2 inhibitor.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-18T10:53:49Z
      DOI: 10.1177/10600280211071089
       
  • Olanzapine/Samidorphan: New Drug Approved for Treating Bipolar I Disorder
           and Schizophrenia

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      Authors: Christie Monahan, Lindsey McCoy, Jason Powell, John G. Gums
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveTo describe the approval of olanzapine/samidorphan, compare the clinical trial data, and summarize key findings, with a focus on impact to clinical practice.Data SourcesA literature search of PubMed was performed (March 2006 to November 2021) using the following search terms: Lybalvi, olanzapine/samidorphan, olanzapine, antipsychotic, bipolar disorder, and schizophrenia. Product monographs, review articles, and randomized control trials were reviewed.Study Selection and Data ExtractionRelevant English-language studies conducted in humans were considered. Primary use of Phase III clinical drug approval trials preferred; supplementary trial analysis evaluated to provide context.Data SynthesisIn June 2021, the Food and Drug Administration (FDA) approved Lybalvi® (olanzapine/samidorphan) for indications including treatment of adults with schizophrenia and/or bipolar I disorder (acute manic episodes or acute episodes with mixed features) through the multi-stage ENLIGHTEN clinical trials. Participants were enrolled in 4-week, 24-week, and 52-week studies to evaluate the safety and efficacy of olanzapine/samidorphan. Subsequent secondary analysis evaluated metabolic effects.Relevance to Patient Care and Clinical PracticeThis review details the pharmacologic, pharmacokinetic, associated dosing and indications, and adverse effects for the drug combination olanzapine/samidorphan. Better understanding of novel drug mechanisms will help to expand on the potential role and place for use in clinical practice.ConclusionWhen treating complex patients with schizophrenia, the olanzapine/samidorphan combination has limited effect on medication-induced weight gain often associated with antipsychotic olanzapine monotherapy. Additional studies are needed to further define the role of olanzapine/samidorphan in bipolar I disorder and clinical practice.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-18T10:52:09Z
      DOI: 10.1177/10600280211070330
       
  • Countries Manufacturing Pharmaceuticals for the US Market: A 10-Year
           Analysis of Public Data

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      Authors: Randy C. Hatton, Greg Leighton, Libbe Englander
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Concerns about strategic supplies and quality have increased the scrutiny of the countries where US pharmaceuticals are made.Objective:To examine the locations of manufacturers of brand name, biological, and generic drugs over 10 years.Methods:This longitudinal descriptive study used publicly available data from US government Web sites, including the Food and Drug Administration (FDA) Drug Establishments list, FDA National Drug Code Directory, FDA Orange Book, FDA Purple Book, and the National Institutes of Health DailyMed Drug Labels. These data were collected from 2011 to 2020.Results:Brand name drug manufacturing in the United States and Europe decreased from 89% in 2011 to 79% in 2020. Biological manufacturing in the United States decreased, while that in Western European countries increased; 100% of biological manufacturing was done in the United States or Europe in 2011 and decreased to 93% by 2020. Generic manufacturing in India increased from 21% to 51%, while US manufacturing decreased from 52% to 35% from 2011 to 2020. These analyses were limited to publicly available data, and the results could be affected by the accuracy and completeness of the data.Conclusions and relevance:Brand name drugs and biologicals are primarily made in the United States and Europe. Generic drugs are increasingly made in India, but the United States remains a major supplier. If the country of origin for pharmaceuticals is important, these findings support supply chain concerns for generic drugs. We recommend that product containers and official labeling prominently include the manufacturer and location for active pharmaceutical ingredients and finished dosage forms.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-18T10:49:22Z
      DOI: 10.1177/10600280211069540
       
  • Site-Specific and Country-of-Origin Labeling for Pharmaceutical
           Manufacturing

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      Authors: Randy C. Hatton, Greg Leighton, Libbe Englander
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      There is increasing concern about the quality of pharmaceuticals, especially generics made in Asia. Popular books and news reports have the public questioning the quality of pharmaceuticals. Recalls and import bans shake confidence in medications, particularly for active pharmaceutical ingredients and finished dosage forms made outside the United States. The Food and Drug Administration uses geography to allocate resources for manufacturing surveillance. Site of manufacturing labeling, including the country, could be linked to the facility’s quality score to assess the risk of poor quality. Clinicians should advocate for legal and regulatory changes to increase the transparency of pharmaceutical manufacturing of products.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-13T11:13:25Z
      DOI: 10.1177/10600280211069541
       
  • Evaluation of Continuous Inhaled Epoprostenol in the Treatment of Acute
           Respiratory Distress Syndrome, Including Patients With SARS-CoV-2
           Infection

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      Authors: Hannah L. Niss, Adham Mohamed, Timothy P. Berry, Timothy M. Saettele, Michelle M. Haines, Elizabeth L. Thomas
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundAcute respiratory distress syndrome (ARDS) management is primarily supportive. Pulmonary vasodilators, such as inhaled epoprostenol (iEPO), have been shown to improve PaO2:FiO2 (PF) and are used as adjunctive therapy.ObjectiveTo identify the positive response rate and variables associated with response to iEPO in adults with ARDS. A positive response to iEPO was defined as a 10% improvement in PF within 6 hours.MethodsThis retrospective study included adults with ARDS treated with iEPO. The primary endpoint was the variables associated with a positive response to iEPO. Secondary endpoints were positive response rate and the change in PF and SpO2:FiO2 within 6 hours. Statistical analysis included multivariable regression.ResultsThree hundred thirty-one patients were included. As baseline PF increased, the odds of responding to iEPO decreased (odds ratio [OR], 0.752, 95% CI, 0.69-0.819, p 
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-13T08:26:21Z
      DOI: 10.1177/10600280211069182
       
  • Evaluation of the Clinical Impact of Thromboprophylaxis in Patients With
           COVID-19 Following Hospital Discharge

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      Authors: Lindsay A. Courtney, Toby C. Trujillo, Joseph J. Saseen, Garth Wright, Surabhi Palkimas
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Data are limited regarding the incidence of thromboembolism post-hospital discharge among COVID-19 patients. Guidelines addressing the role of extended thromboprophylaxis for COVID-19 patients are limited and conflicting.Objective:The purpose of this study was to evaluate the incidence of post-discharge thromboembolic and bleeding events and the role of thromboprophylaxis among COVID-19 patients.Methods:A retrospective analysis was conducted of hospitalized patients with symptomatic COVID-19 infection who were discharged from a University of Colorado Health (UCHealth) hospital between March 1, 2020, and October 31, 2020. The primary outcome was objectively confirmed thromboembolism within 35 days post-discharge. The main secondary outcome was the incidence of bleeding events within 35 days post-discharge. Outcomes were compared between those who received extended prophylaxis and those who did not.Results:A total of 1171 patients met the study criteria. A total of 13 (1.1%) of patients had a documented thromboembolic event and 10 (0.9%) patients had a documented bleeding event within 35 days post-discharge. None of the 132 patients who received extended prophylaxis had a thromboembolic event compared to 13 of 1039 who did not receive extended prophylaxis (0 and 1.3%, respectively; P = .383). The incidence of bleeding was higher among patients who received extended prophylaxis compared to those who did not (3.0% vs 0.6%, P = .019).Conclusions and Relevance:These results suggest that post-discharge extended prophylaxis may be beneficial for select COVID-19 patients, while carefully weighing the risk of bleeding. Application of our findings may assist institutions in development of thromboprophylaxis protocols for discharged COVID-19 patients.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-13T08:12:01Z
      DOI: 10.1177/10600280211064306
       
  • Medication Changes and Diagnosis of New Chronic Illnesses in COVID-19
           Intensive Care Unit Survivors

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      Authors: Rima A. Mohammad, Cynthia T. Nguyen, Patrick G. Costello, Janelle O. Poyant, Siu Yan Amy Yeung, Kaitlin Landolf, Andy Kim, Katherine L. Artman, Dakota C. Taylor, Michael T. Kenes, Tuqa Alkhateeb, Joanna L. Stollings
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundCurrently, there is limited literature on the impact of the COVID-19 infection on medications and medical conditions in COVID-19 intensive care unit (ICU) survivors. Our study is, to our knowledge, the first multicenter study to describe the prevalence of new medical conditions and medication changes at hospital discharge in COVID-19 ICU survivors.ObjectiveTo determine the number of medical conditions and medications at hospital admission compared to at hospital discharge in COVID-19 ICU survivors.MethodsRetrospective multicenter observational study (7 ICUs) evaluated new medical conditions and medication changes at hospital discharge in patients with COVID-19 infection admitted to an ICU between March 1, 2020, to March 1, 2021. Patient and hospital characteristics, baseline and hospital discharge medication and medical conditions, ICU and hospital length of stay, and Charlson comorbidity index were collected. Descriptive statistics were used to describe patient characteristics and number and type of medical conditions and medications. Paired t-test was used to compare number of medical conditions and medications from hospital discharge to admission.ResultsOf the 973 COVID-19 ICU survivors, 67.4% had at least one new medical condition and 88.2% had at least one medication change. Median number of medical conditions (increased from 3 to 4, P < .0001) and medications (increased from 5 to 8, P < .0001) increased from admission to discharge. Most common new medical conditions at discharge were pulmonary disorders, venous thromboembolism, psychiatric disorders, infection, and diabetes. Most common therapeutic categories associated with medication change were cardiology, gastroenterology, pain, hematology, and endocrinology.Conclusion and RelevanceOur study found that the number of medical conditions and medications increased from hospital admission to discharge. Our results provide additional data to help guide providers on using targeted approaches to manage medications and diseases in COVID-19 ICU survivors after hospital discharge.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-13T08:03:40Z
      DOI: 10.1177/10600280211063319
       
  • Finerenone: A Novel Mineralocorticoid Receptor Antagonist for Cardiorenal
           Protection in CKD and T2DM

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      Authors: Allissa Long, Marissa Salvo
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Objective:To describe the pharmacology, clinical and safety evidence, and relevance to clinical practice of finerenone.Data Sources:A literature search was conducted utilizing PubMed, MEDLINE, and clinicaltrials.gov with search terms of “finerenone” and “BAY94-8862.”Study Selection and Data ExtractionAll available studies with human participants in English were considered. Studies were included if they investigated drug pharmacology, efficacy, and safety information.Data SynthesisIn addition to standard of care with a renin-angiotensin system inhibitor (RASi), finerenone lowered the risk of kidney disease progression (17.8% vs 21.1%) in patients with type 2 diabetes mellitus and chronic kidney disease compared to placebo. Similarly, finerenone reduced cardiovascular risk in patients with type 2 diabetes mellitus and chronic kidney disease compared to placebo (12.4% vs 14.2%).Relevance to Patient Care and Clinical PracticeIt is anticipated that finerenone will be added to therapy after a RASi and a sodium-glucose cotransporter-2 inhibitor, as tolerated, based on adverse events and potassium levels.ConclusionsFinerenone offers a unique approach to further delay the progression of chronic kidney disease in patients with type 2 diabetes mellitus. It also provides another option for patients who cannot tolerate RASi or sodium-glucose cotransporter-2 inhibitors.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-13T04:10:03Z
      DOI: 10.1177/10600280211059577
       
  • Impact of Defibrotide in the Prevention of Acute Graft-Versus-Host Disease
           Following Allogeneic Hematopoietic Cell Transplantation

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      Authors: Rémi Tilmont, Ibrahim Yakoub-Agha, Nassima Ramdane, Micha Srour, Valérie Coiteux, Léonardo Magro, Pascal Odou, Nicolas Simon, David Beauvais
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundDefibrotide is indicated for patients who develop severe sinusoidal obstructive syndrome following allogeneic hematopoietic cell transplantation (allo-HCT). Preclinical data suggested that defibrotide carries a prophylactic effect against acute graft-versus-host disease (aGVHD).ObjectiveThe purpose of this study was to investigate the effect of defibrotide on the incidence and severity of aGVHD.MethodsThis single-center retrospective study included all consecutive transplanted patients between January 2014 and December 2018. A propensity score based on 10 predefined confounders was used to estimate the effect of defibrotide on aGVHD via inverse probability of treatment weighting (IPTW).ResultsOf the 482 included patients, 64 received defibrotide (defibrotide group) and 418 did not (control group). Regarding main patient characteristics and transplantation modalities, the two groups were comparable, except for a predominance of men in the defibrotide group. The median age was 55 years (interquartile range [IQR]: 40-62). Patients received allo-HCT from HLA-matched related donor (28.6%), HLA-matched unrelated donor (50.8%), haplo-identical donor (13.4%), or mismatched unrelated donor (7.0%). Stem cell source was either bone marrow (49.6%) or peripheral blood (50.4%). After using IPTW, exposure to defibrotide was not significantly associated with occurrence of aGVHD (HR = 0.97; 95% CI 0.62-1.52; P = .9) or occurrence of severe aGVHD (HR = 1.89, 95% CI: 0.98-3.66; P = .058).Conclusion and RelevanceDefibrotide does not seem to have a protective effect on aGVHD in patients undergoing allo-HCT. Based on what has been reported to date and on these results, defibrotide should not be considered for the prevention of aGVHD outside clinical trials.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-12T07:01:53Z
      DOI: 10.1177/10600280211068177
       
  • Finally, an FDA Approval for an Immunization Against COVID-19: Hope on the
           Horizon

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      Authors: Jason Powell, Christopher R. Piszczatoski
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      ObjectiveCoronavirus disease 2019 (COVID-19) is a respiratory infection known as severe respiratory acute syndrome coronavirus 2 (SARS-CoV-2). The purpose of this manuscript is to review information leading to the Food and Drug Administration (FDA) approval of the Pfizer-BioNTech COVID-19 Vaccine.Data SourcesA literature search was conducted of PubMed and clinicaltrials.gov (August 2018—October 2021) to identify trials related to the FDA approval of Pfizer-BioNTech COVID-19 Vaccine.Study selection and data extractionTrials included are those the FDA deemed significant and accurate enough to be included in the FDA approval process. Information not recognized by the Centers of Disease Control and Prevention (CDC) nor FDA is omitted to not add to further confusion and misinformation.Data synthesisIn persons 16 years or older without evidence of prior SARS-CoV-2 infection, a total of 77 COVID-19 cases (0.39%) in the vaccine group from 7 days onward after the second dose vs 833 (4.1%) in the placebo group (Vaccine efficacy 91.1%; 95% confidence interval [CI]: 88.8-93.1). According the CDC definition of severe infection, there were no severe infections in the vaccine group 7 days and onward after the second dose, compared to 31 (0.15%) in the placebo group (Vaccine efficacy 100%; 95% CI: 87.6-100.0). Relevance to Patient Care and Clinical Practice: Reduction of infection by SARS-COV-2 is a top priority in protecting the health of all people and the official approval of the Pfizer-BioNTech vaccination may improve this goal.ConclusionsData available show a high efficacy rate of preventing SARS -CoV-2 with relatively low rates of ADE after full vaccination with Pfizer-BioNTech COVID-19 vaccine.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-11T06:23:55Z
      DOI: 10.1177/10600280211058387
       
  • Evidence Needed for Efficacy of Antidepressant Medications Among Patients
           With Rheumatoid Arthritis

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      Authors: Armando Silva Almodóvar, Dung Nguyen, Milap C. Nahata
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Patients with rheumatoid arthritis (RA) experience pain from inflammation, joint destruction, and neuropathy. Antidepressants may play a role among patients with RA and depression, fibromyalgia, or neuropathy to achieve desired outcomes. This commentary evaluated evidence for medications individually and identified important variables for future research. While we await the results of well-designed studies, a trial of duloxetine or milnacipran may be considered for patients with remnant pain and RA remission. Research is needed to evaluate the efficacy and safety of serotonin–norepinephrine reuptake inhibitors and tricyclic antidepressants in patients with RA and associated comorbid conditions.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-08T06:13:49Z
      DOI: 10.1177/10600280211062271
       
  • Safety and Efficacy of Various Intravenous Insulin Infusion Rates in
           Patients With and Without Diabetes Presenting With Hypertriglyceridemia

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      Authors: Francisco Ibarra, Kaitlyn Loi, Ann W. Vu
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      BackgroundThe use of IV insulin infusions in the acute management of hypertriglyceridemia has only been evaluated in small observational studies and case reports.ObjectiveTo evaluate the safety and efficacy of IV insulin infusions in the acute management of hypertriglyceridemia.MethodsThis was a retrospective chart review of adult patients who received an IV insulin infusion for the acute management of hypertriglyceridemia. The primary efficacy and safety outcomes were the number of patients who achieved a triglyceride level
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-07T05:57:38Z
      DOI: 10.1177/10600280211070102
       
  • Dark Red Urine in a Patient on Cefiderocol and Ferric Gluconate

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      Authors: Tyler C. Lewis, Serena Arnouk
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-07T05:55:18Z
      DOI: 10.1177/10600280211070029
       
  • Cerebral Venous Sinus Thrombosis in a Young Body Builder Man With Androgen
           Use

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      Authors: Omid Moradi Moghaddam, Moghaddam Nasiripour, Masoumeh Hosseinzadeh Emam, Maryam Farasatinasab
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-07T05:53:22Z
      DOI: 10.1177/10600280211063883
       
  • Balanced Crystalloid Versus Normal Saline as Resuscitative Fluid in
           Diabetic Ketoacidosis

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      Authors: Adriana R. Carrillo, Kirsten Elwood, Chris Werth, Jessica Mitchell, Preeyaporn Sarangarm
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Large volume resuscitation with normal saline (NS) may be associated with iatrogenic hyperchloremia and renal injury.Objective:The purpose of this study was to assess clinical outcomes associated with the use of Lactated Ringer’s (LR) compared to NS as resuscitative fluid in diabetic ketoacidosis (DKA).Methods:Single-center, retrospective analysis of patients admitted for DKA. The primary objective of this study was to evaluate the incidence of iatrogenic hyperchloremia associated with fluid resuscitation using balanced crystalloid compared to NS.ResultsIatrogenic hyperchloremia occurred more frequently in the NS group compared to the LR group (74.4% vs 64.2%; P = 0.05). Mean maximum serum chloride was higher in the NS group (115.7 mmol/L vs 113.7 mmol/L; P = 0.004). Incidence of hypernatremia was higher in the NS group (18.3% vs 9.3%; P = 0.02). There was no significant difference in the incidence of AKI; however, mean change in serum creatinine at 48 hours showed a significantly greater decrease in the LR group (-0.15 mg/dL vs -0.04 mg/dL; P = 0.002). No significant differences were found in intensive care unit (ICU) length of stay or total hospital length of stay.Conclusion and RelevanceThis study found a statistically significant reduction in the incidence of iatrogenic hyperchloremia with the use of LR compared to NS as fluid resuscitation in DKA. Serum creatinine was more improved in the LR group versus NS group at 48 hours. Preferential use of balanced crystalloid for fluid resuscitation in DKA may reduce incidence of hyperchloremia and support renal recovery in this population.
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-06T08:18:42Z
      DOI: 10.1177/10600280211063651
       
  • A Retrospective Characterization of Dexmedetomidine-Suspected Fever and
           Its Consequences in Adult Critically Ill Patients

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      Authors: Emily Schranz, Stephen Rappaport, Christine Groth, Paritosh Prasad, Kevin Cooper, Kathryn Connor
      Abstract: Annals of Pharmacotherapy, Ahead of Print.
      Background:Current evidence for dexmedetomidine-suspected fever (DSF) is limited. Lack of recognition may lead to costly or potentially harmful interventions for critically ill patients.Objective:The primary objective was to characterize escalations of care related to DSF. Secondary objectives were to describe the incidence, severity, and consequences associated with DSF.Methods:A retrospective review was conducted in critically ill adults who developed fever ≥39°C within 12 h from initiation of dexmedetomidine, with resolution of fever to
      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-06T08:17:10Z
      DOI: 10.1177/10600280211060082
       
  • Inclusion of Optimal Guidelines for Pharmacists in UpToDate

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      Authors: Heather J. Ipema, Jessica M. Elste, Laura M. Koppen, Rita Soni, Stefanie Kerns, Rosa Macrito, Thomas Poznanski, Nicole Szydlowski
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-04T07:01:47Z
      DOI: 10.1177/10600280211063950
       
  • Severe Hypocalcemia Due to Skeletal Remineralization After Venetoclax,
           Bortezomib, and Dexamethasone for Relapsed Multiple Myeloma

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      Authors: Lydia Inglezou, Giolanta Tsekou, Ioannis Kotsianidis, Emmanouil Spanoudakis, Konstantinos Liapis
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-04T06:59:27Z
      DOI: 10.1177/10600280211062626
       
  • Data-Tracking Among Digital Pharmacies

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      Authors: Alexander R. Zheutlin, Joshua D. Niforatos, Jeremy B. Sussman
      First page: 958
      Abstract: Annals of Pharmacotherapy, Ahead of Print.

      Citation: Annals of Pharmacotherapy
      PubDate: 2022-01-03T12:23:55Z
      DOI: 10.1177/10600280211061757
       
 
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