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- Antibiotic De-Escalation Practices in the Intensive Care Unit: A
Multicenter Observational Study-
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Authors: Asad E Patanwala, Arwa Abu Sardaneh, Jan-Willem C Alffenaar, Chui Lynn Choo, Alexandra L Dey, Eamon J Duffy, Sarah E Green, Thomas E Hills, Lisa M Howle, Jessica A Joseph, Maxkirivan C Khuon, Cassandra S Koppen, Francis Pang, Jung Yeun Park, Mark A Parlicki, Isha S Shah, Kylie Tran, Priscilla Tran, Mardi A Wills, Jessica H Xu, Marian Youssef Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:There is little known about antibiotic de-escalation (ADE) practices in the intensive care unit (ICU).Objective:The objective was to determine the proportion of patients who received ADE within 24 hours of actionable cultures and identify predictors of timely ADE.Methods:Multicenter cohort study in ICUs of 15 hospitals in Australia and New Zealand. Adult patients were included if they were started on broad-spectrum antibiotics within 24 hours of ICU admission. The ADE was defined as switching from a broad-spectrum agent to a narrower-spectrum agent or antibiotic cessation. The primary outcome was ADE within 24 hours of an actionable culture, where ADE was possible.Results:The 446 patients included in the study had a mean age of 63 ± 16 years, 60% were male, 32% were mechanically ventilated, and 19% were immunocompromised. Of these, 161 (36.1%) were not eligible for ADE and 37 (8.3%) for whom ADE within 24 hours of actionable culture could not be determined. In the remaining 248 patients, ADE occurred ≤24 hours in 60.5% (n = 150/248) after actionable cultures. In the multivariable logistic regression analysis, ADE was less likely to occur within 24 hours for patients with negative cultures (odds ratio [OR] = 0.48, 95% confidence interval [CI] = 0.25-0.92, P = 0.03).Conclusion and Relevance:Timely ADE may not occur in 40% of patients in the ICU and is less likely to occur in patients with negative cultures. Timely ADE can be improved, and patients with negative cultures should be targeted as part of antimicrobial stewardship efforts. Citation: Annals of Pharmacotherapy PubDate: 2024-08-28T05:20:38Z DOI: 10.1177/10600280241271223
- Targeting GPRC5D With Talquetamab: A New Frontier in Bispecific Antibody
Therapy for Relapsed/Refractory Multiple Myeloma-
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Authors: Jacob Shaver, Daniel Horton, Zachery Halford Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To evaluate the pharmacology, clinical efficacy, safety, dosing, administration, and clinical implications of talquetamab-tgvs, a novel bispecific antibody, in the treatment of relapsed or refractory (R/R) multiple myeloma (MM).Data Sources:A comprehensive English-language literature search of PubMed and Clinicaltrials.gov from January 2000 to May 2024 was conducted using the terms talquetamab, Talvey, JNJ-64407564, and “Multiple Myeloma.”Study Selection and Data Extraction:Relevant clinical trials, guidelines, and prescribing information were systematically reviewed and analyzed.Data Synthesis:Talquetamab-tgvs received accelerated approval from the United States Food and Drug Administration based on results from the pivotal phase I/II MonumenTAL-1 clinical trial, which demonstrated an overall response rate of nearly 74% in key cohorts. The median progression-free survival was 7.5 months in the 0.4 mg/kg weekly dosing cohort and 11.9 months in the 0.8 mg/kg biweekly dosing cohort. Treatment-related adverse events (AEs) included cytokine release syndrome, skin- and nail-related AEs, dysgeusia, infections, and immune effector cell-associated neurotoxicity syndrome.Relevance to Patient Care and Clinical Practice:As a first-in-class anti-GPRC5D T-cell-redirecting bispecific antibody, talquetamab-tgvs represents a compelling treatment option for patients with R/R MM who have received at least 4 prior lines of therapy. No head-to-head clinical trials have been conducted comparing talquetamab-tgvs to other T-cell-redirecting therapies.Conclusions:While talquetamab-tgvs showed significant efficacy in the pivotal MonumenTAL-1 trial, long-term safety and efficacy data are needed. Additional clinical trials are necessary to establish the optimal timing, sequencing, patient population, and overall role of talquetamab-tgvs in the rapidly evolving treatment landscape of R/R MM. Citation: Annals of Pharmacotherapy PubDate: 2024-08-28T05:18:19Z DOI: 10.1177/10600280241271192
- Tenecteplase Versus Alteplase: A Comparison of Bleeding Outcomes in
Massive Pulmonary Embolism (TACO-PE)-
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Authors: Jacquelyn Crawford, Austin Roe, Jessica Brumit, Vera Wilson, Jen Tharp Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Thrombolysis is recommended in the setting of massive pulmonary embolism (PE) for reperfusion of vessels but carries a serious concern for increased bleed risk. In October 2022, our institution adopted tenecteplase as the formulary thrombolytic. Previous literature is unclear regarding the bleed risk of tenecteplase in massive PE, and no study has yet compared safety outcomes with the current standard of care, alteplase.Objective:The objective of this study was to compare the incidence of bleeding with tenecteplase versus alteplase in massive PE patients.Methods:This was a retrospective, observational cohort study that included adults who received tenecteplase or alteplase for massive PE. The primary outcome was major bleeding as defined by the International Society on Thrombosis and Hemostasis (ISTH). Secondary outcomes included incidence of symptomatic intracranial hemorrhage (ICH), in-hospital mortality, administration of reversal agents, and length of stay.Results:A total of 44 patients met inclusion criteria with 20 patients in the alteplase cohort and 24 in the tenecteplase cohort. Seventeen percent of tenecteplase patients compared with 5% of alteplase patients experienced bleeding. The mortality rate was 83% vs 75%, respectively. In addition, 1 patient in the tenecteplase cohort experienced a symptomatic ICH and 2 patients required initiation of massive transfusion protocol.Conclusion and Relevance:Although this study was limited in sample size, these results suggest that there may be reason for concern of higher bleeding rates in patients treated with tenecteplase in the setting of massive PE. Citation: Annals of Pharmacotherapy PubDate: 2024-08-21T04:13:12Z DOI: 10.1177/10600280241271264
- Safety of Phenobarbital Versus Benzodiazepines for Alcohol Withdrawal in
Critically Ill Patients With Primary Neurologic Injuries-
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Authors: Robert Deveau, Adrian Wong, Mary Eche, Tuyen Yankama, Corey R. Fehnel Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Alcohol withdrawal syndrome (AWS) is a complication of alcohol use disorder that manifests as a range of symptoms. Symptom-triggered benzodiazepines (BZDs) are often used as first-line treatment of AWS. However, recent literature suggests phenobarbital (PHB) may be safer and more efficacious, but studies are limited by exclusion of patients with neurological injuries.Objective:We aimed to evaluate the safety of PHB compared to BZDs for the management of AWS among patients with primary neurologic injuries.Methods:Retrospective cohort study of patients with primary neurologic injuries admitted to an ICU who received PHB or symptom-triggered BZD for AWS between December 2013 and February 2020. The primary outcome was incidence of oversedation, defined as Richmond Agitation Sedation Scale (RASS) scores from −5 to −3 within 24 hours of initial PHB or BZD dose. Secondary outcomes included largest decrease in RASS, need for mechanical ventilation, and additional sedative use within 24 hours of initial PHB or BZD dose. A multivariable analysis was performed to evaluate the association of PHB administration with the primary outcome.Results:Among 600 patients treated for AWS, 84 patients were included in our analysis (PHB, n = 56; BZD, n = 28). In the unadjusted analysis, there were no differences between the PHB and BZD groups for the primary outcome of oversedation (21.4 vs. 7.1%, P = 0.13), or secondary outcomes of decrease in RASS (P = 0.34), or new ventilator requirement (P = 0.55). Patients who received PHB had higher rates of additional sedative use (P < 0.01). Multivariable regression revealed an increase in oversedation among intubated patients (P = 0.014), while PHB administration was not independently associated with oversedation (P = 0.516).Conclusion and RelevancePhenobarbital did not independently increase the risk of oversedation compared to BZD for AWS in patients with primary neurologic injuries. Future studies should determine optimal dosing of PHB in this population. Citation: Annals of Pharmacotherapy PubDate: 2024-08-21T04:10:32Z DOI: 10.1177/10600280241271156
- Correlation Between Serum and CSF Concentrations of Midazolam and
1-Hydroxy-Midazolam in Critically Ill Neurosurgical Patients-
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Authors: Julie E. Farrar, Sylvia S. Stefanos, Luis Cava, Tyree H. Kiser, Scott W. Mueller, Robert Neumann, Paul M. Reynolds, Deb S. Sherman, Robert MacLaren Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Midazolam (MZ) is commonly used in critically ill neurosurgical patients. Neuro-penetration of MZ and its metabolite, 1-hydroxy-midazolam (1-OH-MZ), is not well characterized.Objective:This study evaluated correlations between serum and cerebrospinal fluid (CSF) concentrations of MZ and 1-OH-MZ and assessed implications on patient sedation.Methods:Adults in the neurosurgical intensive care unit (ICU) with external ventricular drains receiving MZ via continuous infusion were prospectively studied. Serum and CSF samples were obtained 12-24 h and 72-96 h after initiation, and concentrations were determined in duplicate by high-performance liquid chromatography with tandem mass spectrometry. Bivariate correlation analyses used Pearson coefficient.Results:A total of 31 serum and CSF samples were obtained from 18 subjects. At sampling, mean MZ infusion rate was 3.9 ± 4.4 mg/h, and previous 12-h cumulative dose was 51.4 ± 78.2 mg. Mean concentrations of MZ and 1-OH-MZ in serum and CSF were similar between timepoints. Similarly, ratios of 1-OH-MZ to MZ in serum and CSF remained stable over time. Serum MZ (126.2 ± 89.3 ng/mL) showed moderate correlation (r2 = 0.68, P < 0.001) with serum 1-OH-MZ (17.7 ± 17.6 ng/mL) but not CSF MZ (3.9 ± 2.5 ng/mL; r2 = 0.24, P = 0.005) or CSF 1-OH-MZ (2.5 ± 0.6 ng/mL; r2 = 0.47, P = 0.30). CSF MZ did not correlate with CSF 1-OH-MZ (r2 = 0.003, P < 0.001). Mean serum ratio of 1-OH-MZ to MZ (0.14 ± 0.2 ng/mL) did not correlate with CSF ratio (1.06 ± 0.83 ng/mL; r2 = 0.06, P = 0.19). Concentrations and ratios were unrelated to MZ infusion rate or 12-h cumulative dose. Sedation was weakly correlated with CSF 1-OH-MZ, but not with serum MZ, serum 1-OH-MZ, or CSF MZ.Conclusion and Relevance:Continuous infusions of MZ result in measurable concentrations of MZ and 1-OH-MZ in CSF; however, CSF concentrations of MZ and 1-OH-MZ poorly represent serum concentrations or dosages. Accumulation of MZ and 1-OH-MZ in serum or CSF over time was not evident. Concentrations of MZ and 1-OH-MZ do not predict sedation levels, reinforcing that pharmacodynamic assessments are warranted. Citation: Annals of Pharmacotherapy PubDate: 2024-08-21T04:07:52Z DOI: 10.1177/10600280241271130
- Impact of Dexmedetomidine Dosing and Timing on Acute Kidney Injury and
Renal Outcomes After Cardiac Surgery: A Meta-Analytic Approach-
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Authors: Hongpei Li, Lei Wang, Chunxia Shi, Baolong Zhou, Lan Yao Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Acute kidney injury (AKI) is a common and serious complication following cardiac surgery. Dexmedetomidine, a highly selective α2-adrenergic agonist, has shown potential renoprotective effects, but previous studies have yielded conflicting results.Objective:This meta-analysis aimed to evaluate the efficacy and safety of dexmedetomidine in preventing AKI and reducing postoperative serum creatinine levels in adult patients undergoing cardiac surgery.Methods:We comprehensively searched 5 databases for randomized controlled trials comparing dexmedetomidine with control groups in adult cardiac surgery patients. The main outcomes were the incidence of AKI and change in postoperative serum creatinine levels. Meta-analyses were conducted using RevMan 5.4 models, and subgroup analyses were performed based on dexmedetomidine dosing and timing of administration. Continuous outcomes were combined and analyzed using either mean difference (M.D.), while dichotomous outcomes were analyzed using risk ratio (RR) with 95% confidence intervals (CI).Results:Our study included a total of 14 trials involving 2744 patients. Dexmedetomidine administration significantly reduced the incidence of AKI compared to control groups (RR = 0.54, 95% CI: 0.41-0.70, P < 0.00001). Postoperative serum creatinine levels were also lower with dexmedetomidine (MD = −0.14 mg/dL, 95% CI: −0.28 to −0.001, P =0.04). Subgroup analyses revealed that higher initial doses (>0.5 μg/kg) and administration during intraoperative and postoperative periods were associated with more pronounced renoprotective effects. Dexmedetomidine did not significantly affect mortality but reduced the duration of the length of hospital stay and mechanical ventilation.Conclusions and Relevance:This meta-analysis demonstrates that dexmedetomidine administration, particularly at higher doses and during both intraoperative and postoperative periods, reduces the risk of AKI in adults undergoing cardiac surgery. These findings support the use of dexmedetomidine as a preventive strategy to enhance renal outcomes in this population. Citation: Annals of Pharmacotherapy PubDate: 2024-08-21T04:05:52Z DOI: 10.1177/10600280241271098
- Multiple Adverse Reactions Associated With the Use of Second-Generation
Antipsychotics in People With Alzheimer’s Disease: A Pharmacovigilance Analysis Based on the FDA Adverse Event Reporting System-
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Authors: Jianxing Zhou, Zipeng Wei, Wei Huang, Maobai Liu, Xuemei Wu Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Alzheimer’s disease (AD) is a neurodegenerative condition leading to memory loss, cognitive impairment, and neuropsychiatric symptoms. Second-generation antipsychotics (SGAs) are commonly used to manage these neuropsychiatric symptoms, but their safety profile in patients with AD requires further investigation.Objective:The objective was to evaluate the safety of SGAs in patients with AD by analyzing adverse drug reactions (ADRs) using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods:This study conducted a comprehensive analysis of FAERS data from 2014 to 2023, focusing on ADRs in patients with AD treated with SGAs such as risperidone, quetiapine, olanzapine, clozapine, and aripiprazole. Descriptive, disproportionality, time, and dose analysis were performed using the Bayesian confidence propagation neural network, Weibull, and physiologically based pharmacokinetic model.Results:Out of 1289 patients with AD treated with SGAs, the most common ADRs involved the nervous system, gastrointestinal system, and cardiac disorders. Disproportionality analysis identified significant positive signals in cardiac, renal, and vascular systems. Quetiapine, risperidone, and olanzapine showed more positive signals compared with clozapine and aripiprazole. Time analysis indicated that cardiovascular ADRs occurred randomly, whereas renal ADRs increased with prolonged use. Dose analysis suggested that small doses of SGAs did not elevate the risk of multiple cardiac, renal, or vascular ADRs.Conclusion and Relevance:The study underscores the importance of monitoring for ADRs, particularly in the cardiac and renal systems, when using SGAs in patients with AD. Future research incorporating more comprehensive clinical data is warranted to support safe and rational drug utilization. Citation: Annals of Pharmacotherapy PubDate: 2024-08-21T04:03:13Z DOI: 10.1177/10600280241271093
- Effect of Immune Thrombocytopenic Purpura Medications on Depression Risk:
An Analysis of NHANES Data-
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Authors: Feiyue Zheng, Zhengwei Yu, Zhang Zhang, Jinli Miao, Wenmin Wang, Jiaying Wu, Yuefeng Rao Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Immune thrombocytopenic purpura (ITP) in adults typically develops slowly and insidiously. The ITP medications might be linked to psychological disorders, but the connection is not well-understood.Objective:This study aimed to examine the association between ITP medication use and the risk of depression among participants in the National Health and Nutrition Examination Survey (NHANES) from 2005 to 2018.Methods:Using data from 70 190 NHANES participants, we conducted a cross-sectional study, excluding individuals under 18 years, with hypertension, HIV, hepatitis C, and various comorbidities. A total of 17 299 individuals were included in the analysis of this study. We identified 2 populations within this study: those using ITP medications, including prednisone, dexamethasone, and rituximab and those not using ITP drugs. Depression status was assessed using the Patient Health Questionnaire–9 (PHQ-9), and the relationship between ITP medication use and depression was analyzed through multivariate logistic regression.Results:There was no significant association between ITP medication use and an increased risk of depression after adjusting for demographic and health-related variables. Notably, among the study participants, 1.8% of the non-depressed population were on ITP medication compared with 0.3% in the depressed population. The analysis revealed varying depression risks associated with different sociodemographic factors. For instance, the correlation between ITP medication and depression risk was influenced by a combination of age, race, income, and smoking status.Conclusion and Relevance:The study suggests that ITP medication use does not independently increase the risk of depression. This finding is crucial for guiding clinical decisions and managing patient expectations regarding ITP treatment and its psychological impacts. Citation: Annals of Pharmacotherapy PubDate: 2024-08-07T03:57:46Z DOI: 10.1177/10600280241267930
- Sodium-Glucose Co-Transporter 2 Inhibitors and the Risk of Genitourinary
Infections at HbA1c ≥10%: A Population Health-Based Retrospective Review -
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Authors: Bryce Ashby, Marina Kawaguchi-Suzuki, Yvette Grando Holman, Jackie Harris, Rachel Chlasta, Ryan Wargo Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are first-line treatment for type 2 diabetes. Evidence has shown a 3- to 5-fold increase in the risk of genitourinary infections with their use due to inhibition of renal glucose reabsorption, resulting in glucosuria. Increased glucosuria is thought to increase the risk of genitourinary infections at a greater degree in patients with a significantly elevated HbA1c (≥10%), and initiation of SGLT2i is often delayed in these patients. While a limited body of evidence exists indicating that A1c level is not an independent risk factor for SGLT2i-induced genitourinary infection, pragmatically this concern remains a barrier to SGLT2i utilization.Objective:Evaluate the real-world genitourinary (GU) infection rate in patients receiving SGLT2i with a baseline HbA1c ≥10% compared to patients with a baseline HbA1c Citation: Annals of Pharmacotherapy PubDate: 2024-07-30T06:02:02Z DOI: 10.1177/10600280241264585
- Outcome of Drug-Induced Parkinsonism in the Elderly: A Permanent
Nonprogressive Parkinsonian Syndrome May Occur Following Discontinuation of Cinnarizine and Flunarizine-
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Authors: Stefano Calzetti, Anna Negrotti Abstract: Annals of Pharmacotherapy, Ahead of Print. Parkinsonism induced by dopamine receptor antagonists, traditionally considered completely reversible following offending drug withdrawal, may unmask a degenerative parkinsonism in the patients with an underlying subclinical disease. In elderly patients, parkinsonism induced by the calcium channel blockers such as piperazine derivates cinnarizine and flunarizine may persist following drug discontinuation resulting in a permanent nonprogressive syndrome fulfilling the criteria for tardive parkinsonism. Whether this outcome occurs also following exposure to dopamine receptor antagonists such as neuroleptics and benzamide derivates or represents a class effect of the voltage-gated L-type calcium channel blockers, such as cinnarizine and flunarizine, due to their complex pharmacodynamic properties remains to be established. Citation: Annals of Pharmacotherapy PubDate: 2024-07-26T06:44:24Z DOI: 10.1177/10600280241263592
- Review of Subcutaneous Insulin Regimens in the Management of Diabetic
Ketoacidosis in Adults and Pediatrics-
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Authors: Francisco Ibarra, Ryan Bae, Bardya Haghighat Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:Summarize the studies evaluating the use of subcutaneous (SQ) insulin in the management of diabetic ketoacidosis (DKA) in adults and pediatrics.Data Sources:A PubMed literature search was conducted for articles published between 2000 and the end of May 2024 which contained the following terms in their title: (1) subcutaneous, glargine, or basal and (2) ketoa*.Study selection and data extraction:Review articles, guidelines, meta-analysis, commentaries, studies not related to the acute management of DKA, studies evaluating continuous SQ insulin, animal studies, if the time to DKA resolution was not clearly defined, and studies where basal insulin was administered greater than 6 hours after the insulin infusion was started were excluded.Data synthesis:The electronic search identified 58 articles. Following the initial screening 38 articles were excluded and 3 were added after bibliography review. Of the 23 articles assessed for eligibility, 7 were excluded. Sixteen articles were included. Five studies compared SQ rapid/short-acting insulin and intravenous (IV) insulin infusions in adults, 4 compared SQ rapid/short-acting insulin and IV insulin infusions in pediatrics, 4 evaluated IV insulin infusions with or without SQ basal insulin in adults, and 3 evaluated IV insulin infusions with or without SQ basal insulin in pediatrics.Relevance to patient care and clinical practice:In comparison with IV insulin infusions, rapid/short-acting SQ insulin regimens were associated with reduced ICU admission rates, hospital length of stay, and hospitalization costs. IV insulin infusion regimens that included a single SQ basal insulin dose upon therapy initiation were associated with reduced concurrent IV insulin infusion durations.Conclusion:Studies reviewed suggest that SQ insulin regimens may be as effective and safe as IV insulin infusions in the management of DKA and are associated with the conservation of resources. Providers may refer to this review when establishing or modifying their DKA management protocols. Citation: Annals of Pharmacotherapy PubDate: 2024-07-26T06:41:44Z DOI: 10.1177/10600280241263357
- Evaluation of Local Prescribing Patterns and Antimicrobial Resistance in
Women With Acute Pyelonephritis Caused by E. coli-
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Authors: Callie C. Seales, Tanis Welch, Charles F. Seifert Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Owing to increasing local Escherichia coli resistance and current guidelines for the treatment of acute pyelonephritis (APN) over 14 years old, an evaluation of local prescribing patterns is warranted.Objective:The purpose of this study was to evaluate local prescribing patterns and appropriateness of antibiotics in acute uncomplicated APN.Methods:This is a retrospective cohort study of female patients aged 18 to 89 years diagnosed with APN and positive urine culture growing E. coli. Exclusion criteria included pregnancy, immunocompromised status, and complicated urinary tract infections. Outcomes included antibiotic appropriateness and its effects on hospital admission, hospital length of stay, and 30-day readmission.Results:Between 2017 and 2022, 308 female patients were diagnosed with APN and had positive urine cultures, with 104 seen only in the emergency department (ED) and 109 admitted to the hospital. Patients seen in the ED had a significant increase in E. coli resistance to discharge antibiotics (12.5% vs 2.8%, P = 0.0070). In those patients discharged on antibiotics resistant to E. coli, significantly more patients returned to the ED in 30 days (31.3% vs 10.7%, P = 0.0155).Conclusion and Relevance:Patients seen only in the ED were more likely to have resistant organisms to discharge antibiotics compared with those admitted to the hospital. Patients discharged on antibiotics resistant to E. coli had a 3-fold increase in returning to the ED within 30 days regardless of admitted location. Follow-up of all cultures should be performed, and patients resistant to discharge antibiotics should be contacted and antibiotic regimens changed. Citation: Annals of Pharmacotherapy PubDate: 2024-07-26T06:39:44Z DOI: 10.1177/10600280241263067
- Medication Adherence and Treatment Satisfaction With Lipid-Lowering Drugs
Among Patients With Diabetes and Dyslipidemia-
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Authors: Assim A. Alfadda, Amira M. Youssef, Mohammed E. Al-Sofiani, Hussein Saad Amin, Obeed AlOtaibi, Nourhan Mohamed, Hossam Ayed Algohani, Arthur Isnani, Mohamed Rafiullah Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Poor adherence to lipid-lowering drugs in diabetic patients with dyslipidemia increases has been linked with an increased cardiovascular risk. A better understanding of the determinants of adherence to lipid-lowering drugs and treatment satisfaction among people with diabetes and dyslipidemia is crucial.Objective:We aimed to assess the prevalence of adherence to lipid-lowering drugs, identify its determinant factors, and evaluate treatment satisfaction among users of lipid-lowering drugs who have diabetes and dyslipidemia.Methods:We surveyed 398 adult patients with diabetes and dyslipidemia, using a validated medication adherence survey (Adherence to Refills and Medications Scale) and a validated treatment satisfaction survey (Treatment Satisfaction Questionnaire for Medication, TSQM). Sociodemographic and medical history data were collected through questionnaires.Results:The prevalence of poor medication adherence was 36%. Factors associated with poor adherence included adverse reactions to medications, lack of medication availability, and lack of family support. Adherent patients reported lower low-density lipoprotein-cholesterol (LDL-C) and total cholesterol levels, higher treatment satisfaction, and a higher prevalence of cardiovascular disease and comorbidities. Having a family history of dyslipidemia was negatively associated with adherence, while the number of comorbidities positively influenced it. The scores of TSQM components such as effectiveness, global satisfaction, and convenience were significantly higher in people who were adherent or achieved the LDL-C target.Conclusion and Relevance:Our findings highlight the need for interventions targeting several factors impacting adherence to lipid-lowering drugs in patients with diabetes and dyslipidemia. Managing adverse effects, leveraging family support, and ensuring medication access represent crucial aspects of improving adherence and potentially mitigating cardiovascular risks in this high-risk population. Citation: Annals of Pharmacotherapy PubDate: 2024-07-26T06:37:24Z DOI: 10.1177/10600280241262513
- Reply: Pirtobrutinib: A New and Distinctive Treatment Option for B-Cell
Malignancies-
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Authors: Madeline D. Schultze, David J. Reeves Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-07-24T04:48:32Z DOI: 10.1177/10600280241258779
- Comment: Pirtobrutinib: A New and Distinctive Treatment Option for B-Cell
Malignancies-
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Authors: Kayla Lawlor Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-07-24T04:47:32Z DOI: 10.1177/10600280241258777
- The Impact of Ketamine-Based Versus Non-Ketamine-Based ECT Anesthesia
Regimens on the Severity of Patients’ Depression and Occurrence of Adverse Events: A Systematic Review with Meta-Analysis-
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Authors: Dakota J. Sicignano, Rohan Kantesaria, Matthew Mastropietro, Ava Sedensky, Roslyn Kohlbrecher, Adrian V. Hernandez, C. Michael White Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To compare efficacy and safety outcomes for ketamine anesthesia + electroconvulsive therapy (ECT) versus nonketamine anesthesia + ECT in treatment-resistant depression (TRD) patients.Data Sources:PubMed and Embase were searched from the earliest date through November 27, 2023.Study Selection and Data Extraction:Relevant randomized controlled trials (RCTs) of ketamine + ECT versus nonketamine anesthesia + ECT that reported data on remission (odds ratio [OR]), defined as a Hamilton Depression Rating Scale (HAM-D) and Montgomery-Asburg Depression Rating Scale (MADRS) score Citation: Annals of Pharmacotherapy PubDate: 2024-06-19T12:34:01Z DOI: 10.1177/10600280241260754
- Therapeutic Enoxaparin Dosing in Obesity
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Authors: Marcelle Appay, Shreyas Kharadi, Sajani Nanayakkara, Ji Sang Ryu, Leonardo Pasalic, Jan-Willem Alffenaar Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:This review aims to systematically summarize the available data on efficacy and safety of therapeutic enoxaparin in obese patients and to identify gaps to guide future research.Data Sources:Medline and Embase were systematically searched for eligible studies (last searched December 20, 2023). Studies were included if they reported on therapeutic dosing regimens, adverse bleeding, thrombotic outcomes, or antifactor Xa (AFXa) monitoring in obese adult patients.Study Selection and Data Extraction:The systematic review management tool Covidence was used to manage the study selection and data extraction process. The reference list from eligible studies was screened to determine any additional eligible studies.Data Synthesis:Sixteen studies were included in the analysis. Studies used a variety of doses, indications, and study designs making comparison difficult. Twelve studies reported the incidence of thrombotic events (median = 1.3% [interquartile range [IQR] = 0.3%-2.3%]) and all studies reported the incidence of bleeding events (median = 5.7% [IQR = 2.4%-14.5%]). Two of the 8 studies analyzing the influence of weight/body mass index (BMI) or dose per kg on AFXa levels reported statistically significant results. One study concluded that BMI did not affect achievement of target AFXa levels. However, the second study found that dosing using actual body weight was an independent predictor of supratherapeutic AFXa levels in the obese population.Relevance to Patient Care and Clinical Practice:This is the first comprehensive review with a focus on therapeutic dosing of enoxaparin in obesity and has been conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement. Seven of the included studies were published since 2018 indicating that new evidence on this topic is emerging.Conclusion:There was inadequate evidence to support an optimal dosing strategy in obese patients due to the heterogeneity of the studies. The AFXa monitoring may be appropriate to guide dosing in this population. Further research is required to determine a suitable dosing regimen. Citation: Annals of Pharmacotherapy PubDate: 2024-06-19T12:29:55Z DOI: 10.1177/10600280241256351
- Evaluation of Sequential Oral Versus Intravenous Antibiotic Treatment of
Enterococcus faecalis Bloodstream Infections-
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Authors: Carly Loudermilk, Joshua Eudy, Stephanie Albrecht, Cara N. Slaton, Stefanie Stramel, Patrick Tu, Benjamin Albrecht, Sarah B. Green, Jeannette L. Bouchard, Alison I. Orvin, Christian F. Caveness, Andrea Sikora Newsome, Christopher M. Bland, Daniel T. Anderson Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Intravenous (IV) antibiotics have historically been considered standard of care for treatment of bloodstream infections (BSIs). Recent literature has shown sequential oral (PO) therapy to be noninferior to IV antibiotics for certain pathogens and disease states. However, a gap exists in the literature for BSI caused by Enterococcus faecalis.Objective:To compare outcomes of definitive sequential PO therapy to definitive IV therapy in patients with E faecalis BSI.Methods:Multicenter, retrospective, matched cohort study of adult patients with at least one blood culture positive for E faecalis from January 2017 to November 2022. Patients with polymicrobial BSI, concomitant infections requiring prolonged IV antibiotic therapy, those who did not receive antibiotic therapy, and those who died within 72 hours of index culture were excluded. Subjects were matched based on source of infection in a 2:1 (IV:PO) ratio. The primary outcome was a composite of all-cause mortality and treatment failure. Secondary outcomes included hospital length of stay (LOS), antibiotic duration, and 30-day readmission rate.Results:Of the 186 patients who met criteria for inclusion, there was no statistically significant difference in the primary composite outcome for PO compared to IV therapy (14.5% vs 21.8%; OR 0.53 [0.23-1.25]) or 30-day readmission (17.5% vs 29%; OR 0.53 [0.25-1.13]). Hospital LOS was significantly longer in patients receiving IV-only therapy (6 days vs 14 days; P < 0.001).Conclusion and Relevance:Sequential oral therapy for E faecalis BSI had similar outcomes compared to IV-only treatment and may be considered in eligible patients. Citation: Annals of Pharmacotherapy PubDate: 2024-06-18T05:21:50Z DOI: 10.1177/10600280241260146
- Resmetirom: The First Food and Drug Administration–Approved Medication
for Nonalcoholic Steatohepatitis (NASH)-
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Authors: Erenie Guirguis, John Dougherty, Krisy Thornby, Yasmin Grace, Keri Mack Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To review the literature leading to the Food and Drug Administration (FDA) approval of the first medication, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH), including the pharmacology, pharmacokinetics, clinical studies, dosing, and adverse effects. Relevant data will be used to discuss how resmetirom impacts clinical practice.Data sources:A literature search was conducted using MEDLINE from database inception to May 12, 2024. Keywords included non-alcoholic steatohepatitis, nonalcoholic fatty liver disease, and resmetirom. Study selection, data extraction and all English-language studies involving the use of resmetirom for nonalcoholic fatty liver disease (NAFLD)/NASH were included.Data synthesis:Resmetirom, a thyroid hormone receptor agonist, is administered at daily doses of either 80 mg or 100 mg. The drug was shown to provide NASH resolution as assessed by the NAFLD activity score, 80 mg-24.2%, 100 mg-25.9% compared to 14.2% with the placebo group (P < 0.001). Resmetirom, improved liver fibrosis, 80 mg-25.9%, 100 mg-29.9% compared to 9.7% with the placebo group (P < 0.001). Resmetirom’s ability to improve fibrosis in patients with F2-F3 fibrosis offers valuable benefit for patients at risk of progressing to cirrhosis.Relevance to patient care and clinical practice:Resmetirom expands the medication options available to treat patients with NASH which can be given alongside other medications to optimize metabolic factors such as glucagon-like peptide-1 and hydroxymethylglutaryl-coenzyme A reductase inhibitors. Resmetirom was well tolerated in studies.Conclusion:Resmetirom serves as an attractive option in patients diagnosed with NASH with evidence of advanced fibrosis (F2-F3) in combination with exercise, diet, and other multimodal therapies targeting metabolic risk factors. Citation: Annals of Pharmacotherapy PubDate: 2024-06-18T05:18:12Z DOI: 10.1177/10600280241259528
- Reply: Crushed Posaconazole Delayed-Release Tablets Via Enteral Feeding
Tubes: A Cautionary Tale-
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Authors: Nicholas Kane, Ashley Marx Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-06-18T05:15:07Z DOI: 10.1177/10600280241259485
- Administering Crushed Posaconazole Delayed-Release Tablets Should not be
Assumed to Behave Pharmacokinetically as if Swallowed Intact-
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Authors: Ryan W. Stevens, Patrick M. Wieruszewski, Dan Ilges Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-06-18T05:14:56Z DOI: 10.1177/10600280241259484
- Decreased Hepatic Functional Reserve Increases the Risk of
Piperacillin/Tazobactam-Induced Abnormal Liver Enzyme Levels: A Retrospective Case-Control Study-
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Authors: Hayahide Ooi, Yuki Asai, Yoshiki Koriyama, Masaaki Takahashi Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Piperacillin/tazobactam (PIPC/TAZ), which is a combination of a beta-lactam/beta-lactamase inhibitor, often causes liver enzyme abnormalities. The albumin-bilirubin (ALBI) score is a simple index that uses the serum albumin and total bilirubin levels for estimating hepatic functional reserve. Although patients with low hepatic reserve may be at high risk for drug-induced liver enzyme abnormalities, the relationship between PIPC/TAZ-induced abnormal liver enzymes levels and the ALBI score remains unknown.Objective:This study aimed to elucidate the relationship between PIPC/TAZ-induced abnormal liver enzyme levels and the ALBI score.Methods:This single-center retrospective case-control study included 335 patients. The primary outcome was PIPC/TAZ-induced abnormal liver enzyme levels. We performed COX regression analysis with male gender, age (≥75 years), alanine aminotransferase level (≥20 IU/L), and ALBI score (≥−2.00) as explanatory factors. To investigate the influence of the ALBI score on the development of abnormal liver enzyme levels, 1:1 propensity score matching between the ≤−2.00 and ≥−2.00 ALBI score groups was performed using the risk factors for drug-induced abnormal liver enzyme levels.Results:The incidence of abnormal liver enzyme levels was 14.0% (47/335). COX regression analysis revealed that an ALBI score ≥−2.00 was an independent risk factor for PIPC/TAZ-induced abnormal liver enzyme levels (adjusted hazard ratio: 3.08, 95% coefficient interval: 1.207-7.835, P = 0.019). After 1:1 propensity score matching, the Kaplan-Meier curve revealed that the cumulative risk for PIPC/TAZ-induced abnormal liver enzyme levels was significantly higher in the ALBI score ≥−2.00 group (n = 76) than in the Citation: Annals of Pharmacotherapy PubDate: 2024-06-06T06:14:52Z DOI: 10.1177/10600280241255837
- A Case of E138K Cabotegravir/Rilpivirine Resistance: Challenges and
Concerns When Persons Living With HIV Relocate-
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Authors: Patricia Pecora Fulco, Patrick R. Ching Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-06-03T12:17:53Z DOI: 10.1177/10600280241257656
- Comparison of Heart Rates in Patients Initiated on Ticagrelor Versus Other
P2Y12 Inhibitors After an Inferior ST Elevation Myocardial Infarction (STEMI)-
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Authors: Taylor M. Law, Kevin M. Wohlfarth Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:P2Y12 inhibitors have differing associations of bradyarrhythmias. Ticagrelor has been shown to increase adenosine plasma concentrations leading to increases in bradyarrhythmias. While clopidogrel and prasugrel have not been shown to have any association with bradyarrhythmias.Objective:The objective of this study was to determine heart rates after ticagrelor initiation compared to clopidogrel/prasugrel in inferior ST Elevation Myocardial Infarction (STEMI) patients.Methods:This was a retrospective, multicenter study conducted at 3 primary percutaneous coronary intervention (PCI) centers between January 1, 2017 and September 30, 2022. Adult patients were included if they were diagnosed with an inferior STEMI to the right coronary artery (RCA) and treated with PCI followed by an oral P2Y12 inhibitor. The primary outcome was heart rate at 48 hours or discharge, whichever first, after administration of ticagrelor compared to clopidogrel/prasugrel.Results:This study reviewed 331 patients, 172 in the ticagrelor group and 159 in the clopidogrel/prasugrel group. There were no statistical differences between groups regarding the primary outcome, with a median heart rate of 76 beats per minute (bpm) [67-85] in the ticagrelor group versus 73 bpm [66-84] in the clopidogrel/prasugrel group (P = 0.238). No differences were observed between groups regarding any secondary outcomes.Conclusion and relevance:There were similar heart rates between ticagrelor and clopidogrel/prasugrel. There were also similarities in the ability to tolerate beta-blocker therapy after initiation of a P2Y12 inhibitor. The results of this study suggest that in inferior STEMIs when using ticagrelor as the P2Y12 inhibitor, there are not increased clinical manifestations of bradycardia. Citation: Annals of Pharmacotherapy PubDate: 2024-05-31T05:19:42Z DOI: 10.1177/10600280241255111
- Emergency Medicine Physician Residents’ Perceptions of Emergency
Medicine Clinical Pharmacists’ Involvement in Their Training-
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Authors: Francisco Ibarra, Stacy Sawtelle, Mallory Cruz Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Although the clinical impact of emergency medicine clinical pharmacists (EMCPs) on patient care outcomes is well documented, their educational impact on resident physicians’ training is not.Objective:To further highlight the utility of EMCPs, this study evaluated emergency medicine (EM) resident physicians’ perceptions of EMCPs’ involvement in their training.Methods:A voluntary, anonymous web-based survey was sent by email to all 44 EM resident physicians in July 2022. The survey included multiple choice, 5-point Likert scale, and free response questions derived from Accreditation Council for Graduate Medical Education pharmacotherapy competency-based milestones.Results:Thirty-six of the 44 (82%) residents completed the survey and all 10 PGY-4 class residents completed the survey. Nearly half of the respondents (44.4%) reported they consulted/interacted with the EMCPs 3 to 5 times per week and this number increased with the level of training. Respondents most often consulted the EMCPs to obtain medication indications, antibiotic dosing, pediatric dosing, and contraindications. Overall, respondents primarily reported strongly agree to all survey questions. Nearly all respondents strongly agreed the EMCPs are an important part of the patient care team and provide education that is different from what a supervising physician provides. All respondents who completed the pharmacy elective strongly agreed the elective was valuable and strongly recommended other residents to complete it.Conclusion and relevance:Respondents reported EMCPs are an important part of the patient care team, play a significant role in their training, and provide education that is different from what a supervising physician provides. Our findings encourage other institutions to leverage physicians’ views of EMCPs to expand their service line. Citation: Annals of Pharmacotherapy PubDate: 2024-05-31T05:15:19Z DOI: 10.1177/10600280241253383
- Low-Dose Valganciclovir Prophylaxis Against Cytomegalovirus in
Intermediate-Risk Liver and Dual-Abdominal Transplant Recipients-
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Authors: Yihan Li, Dawn M. Pluckrose, Roshani Patolia, Serena Arnouk, Yanina Dubrovskaya, John Papadopoulos, Srijana Jonchhe Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Low-dose valganciclovir (VGC) for cytomegalovirus (CMV) prophylaxis post-transplant has been employed due to cost and safety. The incidence of CMV disease in CMV intermediate-risk liver recipients at 1-year after standard-dose prophylaxis is approximately 5%. However, there are limited data on outcomes after using a “true” low-dose VGC prophylaxis regimen in liver and dual-abdominal transplant recipients as VGC was not dose-adjusted in all patients with impaired renal function in prior studies.Objective:The objective was to assess the incidence of CMV associated with low-dose VGC prophylaxis in CMV intermediate-risk liver, simultaneous pancreas-kidney (SPK), and simultaneous liver-kidney (SLK) recipients with creatinine clearance (CrCl)>60 mL/min.Methods:This was a retrospective review of CMV intermediate-risk liver, SPK, and SLK recipients with CrCl>60 mL/min transplanted January 2018 to June 2022 who received VGC 450 mg daily for prophylaxis. The primary outcome was incidence of CMV infection 6-months post-transplant.Results:Ninety-nine transplant recipients were included (79 liver, 11 SPK, 9 SLK). The primary outcome occurred in 13% of patients (liver 10%, SPK 36%, SLK 10%), including 1 case of CMV disease and 3 breakthrough infections. In addition, 6 patients experienced CMV infection between 6-months and 1-year. Recurrence occurred in 3 patients. There was no evidence of CMV resistance. Thirty patients experienced neutropenia within 1-year, 32 were prescribed granulocyte-colony stimulating factors, and 5 experienced thrombocytopenia. Two patients died due to graft-vs-host disease.Conclusion and Relevance:Low-dose VGC prophylaxis led to comparable CMV infection rates at 6-months in CMV intermediate-risk liver and SLK recipients. However, as SPK recipients displayed higher rates of CMV infection, low-dose VGC should be avoided in this population. Citation: Annals of Pharmacotherapy PubDate: 2024-05-27T11:55:25Z DOI: 10.1177/10600280241255110
- Pharmacotherapy of Hypoactive Sexual Desire Disorder in Premenopausal
Women-
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Authors: Donna Barakeh, Hadil Mdaihly, Lamis R. Karaoui Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:This review aims to provide an overview of pharmacologic management for hypoactive sexual desire disorder (HSDD) in premenopausal women, with a focus on available agents.Data sources:Through a literature search on PubMed, Google Scholar, and ClinicalTrials.gov from 1999 to 2024, studies were selected using the following MeSH search terms: hypoactive sexual desire disorder, premenopause, pharmacologic management, flibanserin, bremelanotide, buspirone, bupropion, and testosterone, excluding those involving postmenopausal women or other sexual disorders. Product monographs were also reviewed.Study selection and data extraction:Relevant English-language studies or those conducted in humans were considered.Data synthesis:Hypoactive sexual desire disorder, characterized by a lack of motivation for sexual activity, predominantly affects women aged 45 years and older. Treatment involves a multimodal approach, including nonpharmacologic interventions such as psychotherapy and lifestyle adjustments, alongside pharmacologic options. Although bupropion and buspirone may be considered off-label treatments, flibanserin and bremelanotide are the sole medications approved by the Food and Drug Administration for generalized acquired HSDD in premenopausal women. However, caution is advised due to their limited efficacy, potential adverse effects, and transparency issues in reporting.Relevance to patient care and clinical practice:Hypoactive sexual desire disorder, while not life-threatening, significantly impacts well-being and relationships. Pharmacotherapy, including options like flibanserin and bremelanotide, is essential within a multidisciplinary approach. Validated tools and objective measures inform tailored premenopausal HSDD care plans and aid in striking a balance between potential risks and adverse effects while maximizing meaningful clinical benefits, including for transgender individuals.Conclusions:Clinicians must discern important distinctions between flibanserin, bremelanotide, and other agents when managing premenopausal HSDD. Further research with the most suitable clinical endpoints and consideration of patient factors are crucial before widespread adoption of flibanserin and bremelanotide. Pharmacists are encouraged to embrace this opportunity to provide premenopausal HSDD care in ambulatory and community practice settings. Citation: Annals of Pharmacotherapy PubDate: 2024-05-20T12:08:39Z DOI: 10.1177/10600280241253273
- Fentanyl Levels May Be Unchanged With Extracorporeal Membrane Oxygenation
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Authors: Jennifer W. Chou, Matthew Mueller, Christopher Tainter, Travis Pollema, Cassia Yi, Mazen Odish, E. Orestes O’Brien Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-05-20T12:07:00Z DOI: 10.1177/10600280241249501
- Buprenorphine in the Intensive Care Unit: Commentary on the Unanswered
Questions-
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Authors: David J. Gagnon, Melody J. Glenn, Aurora A. Quaye, Brian L. Erstad Abstract: Annals of Pharmacotherapy, Ahead of Print. The removal of the X-waiver in the Mainstreaming Addiction Treatment (MAT) Act of 2023 has substantial implications for buprenorphine prescribing as one of the options to treat opioid use disorder. The purpose of this commentary is to discuss the unanswered questions regarding buprenorphine in the intensive care unit (ICU) including how the passage of the MAT Act will affect ICU providers, which patients should receive buprenorphine, what is the most appropriate route of administration and dose of buprenorphine, what medications interact with buprenorphine, and how can transitions of care be optimized for these patients. Citation: Annals of Pharmacotherapy PubDate: 2024-05-17T05:29:14Z DOI: 10.1177/10600280241254528
- Spesolimab: A Review of the First IL-36 Blocker Approved for Generalized
Pustular Psoriasis-
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Authors: Gaurav N. Pathak, Emily Wang, Jimmy Dhillon, Prachi N. Parikh, Reem Esseghir, Babar K. Rao, Steven R. Feldman Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:This article reviews clinical trial data that assesses the safety, efficacy, and clinical application of spesolimab, an interleukin-36 (IL-36) blocker, for the treatment of generalized pustular psoriasis (GPP).Data sources:A review of the literature was conducted using the search terms: “spesolimab,” “BI 655130,” and “spevigo” in MEDLINE (PubMed) and Clinicaltrials.gov from January 1, 1950 to October 31, 2023.Study selection and data extraction:Relevant articles in English relating to the pharmacodynamics, pharmacokinetics, efficacy, and safety of spesolimab were included.Data Synthesis:In one phase 2 clinical trial evaluating single dose IV spesolimab for GPP flares at day 8, 54% of patients receiving spesolimab had a GPP physician global assessment (GPPGA) pustulation subscore of 0, and 43% had a GPPGA total score of 0 compared with 6% and 11% for the placebo group, respectively. Another phase 2 clinical trial assessing subcutaneous spesolimab found 23% of patients in low-dose, 29% in medium-dose, and 10% of high-dose spesolimab had flares by week 48 compared with 52% of the placebo group. Hazard ratios for time to GPP flare compared with placebo were 0.16 (P = 0.0005), 0.35 (P = 0.0057), and 0.47 (P = 0.027) for the spesolimab groups, respectively. Infection rates were similar across treatment and placebo groups, and severe adverse events such as drug reactions with eosinophilia and systemic symptom (DRESS), cholelithiasis, and breast cancer occurred with spesolimab.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Spesolimab is a first-in-class IL-36 monoclonal antibody receptor antagonist approved for the treatment of acute GPP flares. It is a safe and effective therapeutic agent in preventing future GPP flares, with no current comparator trials with other GPP agents.Conclusion:Spesolimab is a safe and effective treatment for acute GPP flares in adults. Future clinical trials can establish safety and efficacy compared with other agents. Citation: Annals of Pharmacotherapy PubDate: 2024-05-17T05:27:36Z DOI: 10.1177/10600280241252688
- Exploring the Link Between Exogenous Thyroid Hormones and Dementia
Symptoms: A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System-
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Authors: Jianxing Zhou, Weipeng Lai, Zipeng Wei, Baohua Xu, Maobai Liu, Nanwen Zhang, Xuemei Wu Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:A growing body of evidence indicates a strong association between exogenous thyroid hormone (ETH) and brain health. Establishing the potential relationship between ETH therapy and dementia symptoms is crucial for patients with thyroid disorders.Objective:In this study, we investigate the potential association between ETH therapy and dementia symptoms by exploring the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods:Disproportionality analysis (DPA) was conducted using postmarketing data from the FAERS repository (Q1 2004 to Q4 2023). Cases of dementia symptoms associated with ETH therapy were identified and analyzed through DPA using reporting odds ratios and information component methods. Dose and time-to-onset analyses were performed to assess the association between ETH therapy and dementia symptoms.Results:A total of 9889 cases of ETH-associated symptoms were identified in the FAERS database. Dementia accounted for a consistent proportion of adverse drug reactions each year (3.4%-6.3%). The DPA indicated an association between ETH therapy and dementia symptoms, which remained significant even across sex, age, and indications. The median time-to-onset of dementia symptoms was 7.5 days, and the median treatment time was 40.5 days. No significant dose-response relationship was observed.Conclusion and relevance:This study provides evidence for a link between ETH therapy and dementia. Clinicians are therefore advised to exercise vigilance, conduct comprehensive monitoring, and consider individualized dosing to mitigate potential reactions to ETH drug administration. Citation: Annals of Pharmacotherapy PubDate: 2024-05-17T05:17:34Z DOI: 10.1177/10600280241252211
- A Case of Angioedema to Oral Doxycycline and Cross-Reactivity to
Minocycline-
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Authors: Jieun Yu, Da Woon Sim Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-05-14T09:04:12Z DOI: 10.1177/10600280241252542
- Real-Time Use of SGLT2i Verified in Pre-dialysis: The RSVP Cross-sectional
Study-
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Authors: Aylon Wisbaum, Sandrine Gaudreau, Isabelle Cloutier, Pascale Robert, Regina Kolment, Marie-France Beauchesne, Jodianne Couture Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:The use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in nephrology practice is increasingly becoming standard of care in patients with diabetes or those with proteinuria.Objectives:The primary outcome was to identify the proportion of pre-dialysis patients with chronic kidney disease (CKD) G3a, G3b, or G4 prescribed an SGLT2i and describe their characteristics.Methods:This was a retrospective, multicentric, cross-sectional study of patients with CKD followed at 4 pre-dialysis clinics in the province of Quebec, Canada. We collected data of multiple covariates associated with prescribing SGLT2i in patients over 18 years of age with CKD G3a, G3b, or G4. We then performed a multivariate logistic regression to assess their associations.Results:Of the 874 patients included, 22.7% were prescribed an SGLT2i. Factors most strongly associated included male sex (odds ratio [OR] = 4.88, 95% CI = 2.38-10.03), being prescribed metformin (OR = 4.30, 95% CI = 2.23-8.31), having type 2 diabetes (OR = 4.00, 95% CI = 1.86-8.62), or having an albumin-to-creatinine ratio greater than 300 mg/g (OR = 1.84, 95% CI = 1.08-3.14). The majority of patients (60.4%) had their SGLT2i initiated by the pre-dialysis clinic and the most frequent adverse event was an initial increase in serum creatinine 1 week after starting treatment (33.9%).Conclusion and relevance:An increasing number of patients with CKD are being prescribed SGLT2i. Nonetheless, significant disparities in sex, severity of disease, and comorbidities remain. We suggest that specific strategies be put in place to promote prescribing of SGLT2i in women and other at-risk populations, in particular among nephrology teams, to improve patient care. Citation: Annals of Pharmacotherapy PubDate: 2024-05-13T06:42:25Z DOI: 10.1177/10600280241245995
- Crushed Posaconazole Delayed-Release Tablets Via Enteral Feeding Tubes: A
Cautionary Tale-
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Authors: Nicholas Kane, Rachel Rikard, Katie McCrory, Ashley Marx Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-04-30T09:59:54Z DOI: 10.1177/10600280241249705
- Temporarily Reversing Warfarin With Low-Dose 4-Factor Prothrombin Complex
Concentrate in Left Ventricular Assist Device Patients Undergoing an Invasive Procedure-
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Authors: Byron Stevenson, A. Joshua Roberts, William E. Dager Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:American Association for Thoracic Surgery and The International Society for Heart and Lung Transplantation (AATS/ISHLT) guidelines recommend warfarin in patients with continuous-flow left ventricular assist devices (LVADs) to reduce the risk of device thrombosis and systemic embolization. Left ventricular assist device patients often undergo elective and emergent procedures that require interrupted anticoagulation. Data and experience vary on the optimal strategy to rapidly reverse warfarin in LVAD patients when an emergent procedure is planned.Objective:The purpose of this study was to describe the use of 4-factor prothrombin complex concentrate (PCC4) for warfarin reversal in patients with LVADs undergoing elective and emergent procedures.Methods:This retrospective, single-center, cohort review describes the use of PCC4 in patients with LVADs who require warfarin reversal for elective or emergent procedures. The primary outcome was a composite incidence of pump thrombosis, venous thromboembolism, and ischemic stroke within 30 days of PCC4 administration.Results:In total, 14 patients received 17 administrations of PCC4. One patient received 3 administrations, and 1 other patient received 2 administrations during separate encounters. The median dose was 500 units or 6.6 units/kg (range = 4.2-14.1 units/kg). Of the PCC4 administrations, 82% (14/17) were for low bleed risk procedures and 76% (13/17) were for elective procedures. There were no cases of pump thrombosis, venous thromboembolism, or stroke within 30 days of the procedure.Conclusions and Relevance:Low-dose PCC4 appears to be a safe and effective temporary reversal strategy for patients with LVADs undergoing low-bleed risk elective procedures. Citation: Annals of Pharmacotherapy PubDate: 2024-04-28T04:33:13Z DOI: 10.1177/10600280241248172
- Transdermal Opioids and the Quality of Life of the Cancer Patient: A
Systematic Literature Review-
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Authors: Patricia Santos Reis, Durval Campos Kraychete, Emilie de Magalhães Pedreira, Eduardo Silva Reis Barreto, César Romero Antunes Júnior, Vinicius Borges Alencar, Anna Karla do Nascimento Souza, Liliane Elze Falcão Lins-Kusterer, Liana Maria Torres de Araujo Azi Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:This systematic literature review aims to evaluate the effectiveness of transdermal opioids in managing cancer pain and their impact on the quality of life (QoL) of patients.Data sources:A systematic literature review conducted following the PRISMA protocol, focusing on randomized clinical trials found in the Lilacs, Embase, PubMed, and SciELO databases over the last 20 years.Study selection and data extraction:We included randomized clinical trials, published in English, Portuguese, or Spanish, which assessed the impact of transdermal opioids on the QoL. Data extraction was facilitated using the Rayyan app.Data synthesis:Six articles meeting the inclusion and exclusion criteria were analyzed. These studies covered a population ranging from 24 to 422 cancer patients experiencing moderate to severe pain. The risk of bias was assessed in each study, generally being categorized as uncertain or high.Relevance to patient care and clinical practice:The findings indicate that the analgesic effectiveness and side effects of transdermal formulations (specifically buprenorphine and fentanyl) for managing moderate to severe cancer pain are comparable to, or in some cases superior to, those of oral opioids traditionally employed.Conclusions:Transdermal therapy was suggested to have several advantages over oral opioid therapy in enhancing cancer patients’ QoL. These benefits span various dimensions, including pain management, physical functioning, mental health, vitality, overall patient improvement, anger/aversion, strength/activity, general QoL, cognitive and emotional functions, fatigue, and insomnia. Citation: Annals of Pharmacotherapy PubDate: 2024-04-25T05:46:19Z DOI: 10.1177/10600280241247363
- Nirsevimab: Expansion of Respiratory Syncytial Virus Prevention Options in
Neonates, Infants, and At-Risk Young Children-
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Authors: J. Hunter Fly, Lea S. Eiland, Jeremy S. Stultz Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:Review available data from clinical trials of nirsevimab for efficacy and safety in the setting of respiratory syncytial virus (RSV) prophylaxis in infants and children, while exploring nirsevimab’s role in clinical practice and highlighting continuing questions.Data sources:A literature search of PubMed was conducted utilizing the phrases “nirsevimab” and “medi8897.” Additional references were identified through found references. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized.Study selection and data extraction:Relevant clinical trials investigating nirsevimab in infants and children were included as well as other references on pharmacology, pharmacokinetics, and pharmacoeconomics.Data synthesis:Nirsevimab, a once-a-season monoclonal antibody, demonstrated a 79.5% (95% CI, 65.9-87.7; P < 0.00001) lower incidence of RSV-associated medically attended lower respiratory tract infections (MA RSV-associated LRTI) and 77.3% (95% CI, 50.3-89.7; P = 0.0002) reduction in hospitalizations for RSV-associated MA-LRTI across 2 placebo-controlled studies. Nirsevimab demonstrated comparable safety to placebo with minor dermatologic reactions being the most common adverse event (0.9% vs 0.6%).Relevance to patient care and clinical practice in comparison with existing agents:Nirsevimab was approved by the US Food and Drug Administration, and recommended by the Advisory Committee on Immunization Practices and American Academy of Pediatrics for broad administration to infants entering their first RSV season and at risk patients during their second RSV season. Questions remain over efficacy in infants born < 29-week gestation and other economical considerations.Conclusions:Nirsevimab demonstrated clinical efficacy in reducing RSV-associated MA-LRTI and RSV-associated hospitalizations in infants and was well tolerated. Citation: Annals of Pharmacotherapy PubDate: 2024-04-24T04:46:03Z DOI: 10.1177/10600280241243357
- Abbreviated Urine Collection Compared With 24-Hour Urine Collection for
Measuring Creatinine Clearance in Adult Critically Ill Patients: A Systematic Review-
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Authors: Mohamed Omar Saad, Adham Mohamed, Mohamed Izham Mohamed Ibrahim Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To evaluate the accuracy of abbreviated urine collection (≤12 hours) compared with 24-hour urine collection for measuring creatinine clearance (CrCl) in critically ill adult patients.Data Sources:We searched PubMed, Embase, Web of Science, Google Scholar, and ProQuest Dissertations and Thesis Global; screened reference lists of included studies; and contacted the authors when needed. English studies only were considered with no restriction on dates.Study Selection and Data Extraction:After duplicate removal, 2 reviewers screened titles/abstracts, reviewed full-text articles, and extracted data independently. Studies that compared abbreviated versus 24-hour urine collection for measuring CrCl were included. We assessed the risk of bias using the QUADAS-2 tool. We extracted correlation coefficients, mean prediction errors (ME)—as a measure of bias, and root mean squared prediction errors (RMSE)—as a measure of precision.Data Synthesis:Five studies were included, comprising 528 adult critically ill adults from surgical, medical, and trauma intensive care units (ICUs). Three studies had high risk of bias, and 2 had low risk. The studies evaluated different durations of urine collection, including 30-minute, 2-hour, 4-hour, 6-hour, and 12-hour. Mean 24-hour CrCl ranged from 57 mL/min/1.73 m2 to 103 mL/min. Abbreviated urine collection led to CrCl that correlated well with the 24-hour measured CrCl (correlation coefficient ranged from 0.8 to 0.95). Mean prediction error ranged from 5 mL/min/1.73 m2 to 16 mL/min (from 8% to 25% of the 24-hour CrCl). Root mean squared prediction error calculated from 1 study was 30.5 mL/min/1.73 m2.Relevance to Patient Care and Clinical Practice:Abbreviated urine collection is used to measure CrCl for renal drug dosing in critically ill patients, but its accuracy is not well-established.Conclusions:Abbreviated urine collection may overestimate CrCl compared with 24-hour urine collection. Larger, well-conducted studies are needed to evaluate the accuracy of CrCl measured using different durations of urine collection in critically ill patients. Citation: Annals of Pharmacotherapy PubDate: 2024-04-15T10:26:05Z DOI: 10.1177/10600280241241820
- Daprodustat: A Hypoxia-Inducible Factor–Prolyl Hydroxylase Inhibitor for
Anemia of Chronic Kidney Disease-
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Authors: Haley N. Johnson, Lalita Prasad-Reddy Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:The objective was to review the safety and efficacy of daprodustat, a hypoxia-inducible factor–prolyl hydroxylase inhibitor (HIF-PHI) in the treatment of anemia of chronic kidney disease (CKD).Data Sources:A literature search was conducted in MEDLINE, EMBASE, and ClinicalTrials.gov using the keywords “daprodustat,” “GSK1278863,” and “hypoxia-inducible factor-prolyl hydroxylase inhibitors” from January 2010 through November 2023.Study Selection and Data Extraction:Literature was included if it evaluated pharmacology, pharmacokinetics, efficacy, and/or safety of daprodustat in human subjects and was reported in English. The manufacturer’s product monograph was also utilized.Data Synthesis:Daprodustat significantly increased hemoglobin levels in CKD patients on dialysis (difference 0.18 g/dL) and not on dialysis (difference 0.08 g/dL) over 52-week treatment periods compared with erythropoiesis stimulating agents (ESA) in Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat (ASCEND)-D and ASCEND-ND, respectively. First occurrence of major adverse cardiovascular events (MACEs) was similar between daprodustat and ESAs in both trials.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Daprodustat can be used in patients with CKD on dialysis and already receiving an ESA for at least 6 weeks to further increase serum hemoglobin levels without increasing the risk of MACE. Adverse effects of daprodustat that may occur more than ESAs include headache, emesis, and thrombosis.Conclusions:Daprodustat is a novel oral, non-iron therapy for treatment of anemia of CKD. It was Food and Drug Administration approved in 2023 in patients already receiving dialysis for at least 4 months but not in non-dialysis patients. Long-term data for safety and additional benefits are pending. Citation: Annals of Pharmacotherapy PubDate: 2024-04-15T06:05:21Z DOI: 10.1177/10600280241241563
- Amiodarone-Induced Psoriasiform Dermatitis
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Authors: Myriam Agrebi, Dhouha Sahnoun, Najet Ghariani, Mohamed Denguezli, Chaker Ben Salem Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-04-09T05:56:16Z DOI: 10.1177/10600280241244511
- Clinical Outcomes Associated With Diltiazem Use in Heart Failure With
Reduced Ejection Fraction After Implementation of a Clinical Support System-
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Authors: Elizabeth M. Foster, James C. Coons, Elena A. Puccio, Danine Sullinger, Rachel Ibrahim, Joseph Ibrahim, Gavin W. Hickey, Edward Horn, Vincent Mosesso, Ryan M. Rivosecchi Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Despite atrial fibrillation guideline recommendations, many patients with heart failure with reduced ejection fraction (EF) continue to receive IV diltiazem for acute rate control.Objective:Our institution recently implemented a clinical decision support system (CDSS)-based tool that recommends against the use of diltiazem in patients with an EF ≤ 40%. The objective of this study was to evaluate outcomes of adherence to the aforementioned CDSS-based tool.Methods:This multi-hospital, retrospective study assessed patients who triggered the CDSS alert and compared those who did and did not discontinue diltiazem. The primary outcome was the occurrence of clinical deterioration. The primary endpoint was compared utilizing a Fisher’s Exact Test, and a multivariate logistic regression model was developed to confirm the results of the primary analysis.Results:A total of 246 patients were included in this study with 146 patients in the nonadherent group (received diltiazem) and 100 patients in the adherent group (did not receive diltiazem). There was a higher proportion of patients experiencing clinical deterioration in the alert nonadherence group (33% vs 21%, P = 0.044), including increased utilization of inotropes and vasopressors, and higher rate of transfer to ICU.Conclusion and Relevance:In patients with heart failure with reduced EF, diltiazem use after nonadherence to a CDSS alert resulted in an increased risk of clinical deterioration. This study highlights the need for improved provider adherence to diltiazem clinical decision support systems. Citation: Annals of Pharmacotherapy PubDate: 2024-04-04T06:55:29Z DOI: 10.1177/10600280241243071
- Capivasertib: A Novel AKT Inhibitor Approved for
Hormone-Receptor-Positive, HER-2-Negative Metastatic Breast Cancer-
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Authors: Alexa J. Luboff, David L. DeRemer Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To review the pharmacology, efficacy, and safety of capivasertib for the treatment of adults with hormone receptor-positive, HER2-negative (HR+/HER2–) locally advanced or metastatic breast cancer with 1 or more PIK3CA/AKT1/PTEN alterations.Data sources:A literature search was conducted using PubMed and MEDLINE databases, published abstracts, and studies from ClinicalTrials.gov between 2003 and February 2024. Keywords included capivasertib, AZD5363, PI3K/AKT/mTOR pathway, and breast cancer.Data extraction:All applicable publications, package inserts, meeting abstracts, and clinical trials with capivasertib were reviewed.Data synthesis:Capivasertib is a first-in-class inhibitor of 3 isoforms of AKT (AKT-1, AKT-2, and AKT-3) which is an essential component in the PI3K/AKT/mTOR signaling pathway involved in oncogenesis. In the phase III CAPItello-291 trial, capivasertib in combination with fulvestrant (C+F) demonstrated improved progression-free survival (PFS) (7.3 vs 3.1 months) compared with placebo-fulvestrant (P+F) cohort in AKT-altered pathway patients who had progressed through prior aromatase inhibitor. The most common adverse reactions of any grade reported in the C+F group were diarrhea, cutaneous skin reactions, nausea, fatigue, and vomiting.Relevance to patient care and clinical practice in comparison with existing drugs:HR+/HER2– advanced breast cancer patients experience progression following endocrine therapies and cyclin-dependent kinase (CDK) 4/6 inhibitors. Capivasertib is a viable treatment option for patients with PIK3CA/AKT1/PTEN activating mutations following progression on endocrine-based regimens in the metastatic setting or recurrence within 12 months of completing adjuvant therapy.Conclusion:Integration of capivasertib into clinical practice is ongoing; intermittent dosing and favorable toxicity are attractive for future novel combination prospective trials. Citation: Annals of Pharmacotherapy PubDate: 2024-04-03T04:18:43Z DOI: 10.1177/10600280241241531
- Vaccines for Respiratory Syncytial Virus Prevention in Older Adults
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Authors: Daniel Wroblewski, Lindsay A. Brust-Sisti, Matthew Bridgeman, Mary Barna Bridgeman Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:This review evaluates the efficacy and safety of novel respiratory syncytial virus (RSV) vaccines approved for adults aged 60 years and older.Data Sources:A literature search through February 27, 2024 was conducted using search terms, such as RSV, viral respiratory illness, vaccine, RSVpreF, RSVpreF3, Prefusion F, Abrysvo, and Arexvy.Study Selection and Data Extraction:Data from primary literature and vaccine prescribing information were reviewed, encompassing evaluations of clinical pharmacology, efficacy, safety, adverse events, warnings, and precautions.Data Synthesis:The literature review process resulted in 10 articles included within this article’s scope, including the results of 2 major phase III trials presented in detail. Two RSV vaccines, Respiratory Syncytial Virus Vaccine (recombinant [adjuvanted]; RSVpreF3-ASO1E, Arexvy) and Respiratory Syncytial Virus Vaccine (recombinant; RSVpreF, Abrysvo), approved for preventing RSV-associated lower respiratory tract disease (LRTD) in adults aged 60 years or older in the United States are discussed. Results from Phase III trials have demonstrated the efficacy of 1 dose of these vaccines in preventing RSV-associated LRTD across 2 RSV seasons.Relevance to Patient Care and Clinical Practice:The Advisory Committee on Immunization Practices currently recommends use of these vaccines under shared clinical decision-making for adults aged 60 years or older. Most common adverse effects include injection site reactions (eg, site pain, redness, and swelling). Administration requires a single intramuscular injection of 0.5 mL, reconstituted prior to administration.Conclusions:The RSVpreF3-ASO1E and RSVpreF vaccines effectively prevent RSV-associated LRTD in adults aged 60 years and older. Citation: Annals of Pharmacotherapy PubDate: 2024-04-02T12:56:54Z DOI: 10.1177/10600280241241049
- Role of a Pharmacist in Postdischarge Care for Patients With Kidney
Disease: A Scoping Review-
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Authors: Melanie M. Manis, Jessica W. Skelley, J. Braden Read, Rebecca Maxson, Emma O’Hagan, Jessica L. Wallace, Edward D. Siew, Erin F. Barreto, Samuel A. Silver, Sandra L. Kane-Gill, Javier A. Neyra Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:The objective was to explore and describe the role of pharmacists in providing postdischarge care to patients with kidney disease.Data Sources:PubMed, Embase (Elsevier), CINAHL (Ebscohost), Web of Science Core Collection, and Scopus were searched on January 30, 2023. Publication date limits were not included. Search terms were identified based on 3 concepts: kidney disease, pharmacy services, and patient discharge. Experimental, quasi-experimental, observational, and qualitative studies, or study protocols, describing the pharmacist’s role in providing postdischarge care for patients with kidney disease, excluding kidney transplant recipients, were eligible.Study Selection and Data Extraction:Six unique interventions were described in 10 studies meeting inclusion criteria.Data Synthesis:Four interventions targeted patients with acute kidney injury (AKI) during hospitalization and 2 evaluated patients with pre-existing chronic kidney disease. Pharmacists were a multidisciplinary care team (MDCT) member in 5 interventions and were the sole provider in 1. Roles commonly identified include medication review, medication reconciliation, medication action plan formation, kidney function assessment, drug dose adjustments, and disease education. Some studies showed improvements in diagnostic coding, laboratory monitoring, medication therapy problem (MTP) resolution, and patient education; prevention of hospital readmission was inconsistent. Limitations include lack of standardized reporting of kidney disease, transitions of care processes, and differences in outcomes evaluated.Relevance to Patient Care and Clinical Practice:This review identifies potential roles of a pharmacist as part of a postdischarge MDCT for patients with varying degrees of kidney disease.Conclusions:The pharmacist’s role in providing postdischarge care to patients with kidney disease is inconsistent. Multidisciplinary care teams including a pharmacist provided consistent identification and resolution of MTPs, improved patient education, and increased self-awareness of diagnosis. Citation: Annals of Pharmacotherapy PubDate: 2024-04-02T01:05:49Z DOI: 10.1177/10600280241240409
- Live Biotherapeutic Products for the Prevention of Recurrent
Clostridioides difficile Infection-
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Authors: Natasha N. Pettit, Kristy M. Shaeer, Elias B. Chahine Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To review the efficacy, safety, and role of live biotherapeutic products (LBPs) in the prevention of recurrent Clostridioides difficile infection (rCDI).Data Sources:A literature search was performed using PubMed and Google Scholar (through February 2024) with search terms RBX2660, SER-109, and fecal microbiota. Other resources included abstracts presented at recent conferences, national clinical practice guidelines, and manufacturers’ websites.Study Selection and Data Extraction:All relevant studies, trial updates, conference abstracts, and guidelines in the English language were included.Data Synthesis:Two LBPs were recently approved by the Food and Drug Administration for the prevention of recurrence in adults following antibiotic treatment for rCDI. Fecal microbiota, live-jslm is administered rectally as a retention enema, whereas fecal microbiota spores, live-brpk is given orally after bowel preparation. Several phase 2 and phase 3 clinical trials have established the safety and efficacy of these LBPs in reducing rates of rCDI compared with placebo. Patients with severe immunosuppression and those with inflammatory bowel disease were largely excluded from these trials.Relevance to Patient Care and Clinical Practice in Comparison with Existing Drugs:Live biotherapeutic products offer a similar mechanism to conventional fecal microbiota transplant (FMT) in preventing rCDI through microbiota restoration. The primary advantages of LBPs over FMT are their standardized composition and donor stool screening processes for transmissible pathogens. Bezlotoxumab is also available for the prevention of Clostridioides difficile infection; however, there are no clinical data available to compare the efficacy of LBPs with bezlotoxumab, and the benefit of simultaneous use of these preventative therapies is unclear.Conclusions:Live biotherapeutic products provide a safe and effective option for the prevention of rCDI and represent an improvement over conventional FMT. Additional studies are needed to further determine their place in therapy relative to bezlotoxumab and in the setting of immunosuppression and inflammatory bowel disease. Citation: Annals of Pharmacotherapy PubDate: 2024-03-28T12:07:38Z DOI: 10.1177/10600280241239685
- Increased Theophylline Plasma Concentrations in a Patient With Covid-19
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Authors: Miriam Rodríguez Fernández, Ana Concepción Sánchez Cerviño, Ana Codonal Demetrio, Nagore Lois Martínez, Benito García Díaz Abstract: Annals of Pharmacotherapy, Ahead of Print.
Citation: Annals of Pharmacotherapy PubDate: 2024-03-27T09:40:28Z DOI: 10.1177/10600280241239936
- Rozanolixizumab: A New Therapy in the Treatment of Myasthenia Gravis
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Authors: Emily M. Hitt Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:The aims of this article are to review the clinical aspects of rozanolixizumab, to describe clinical trial results that led to the drug’s approval, and to examine the impact on patient care to aid clinical decision making.Data Sources:A PubMed search was conducted using the terms Rystiggo™, rozanolixizumab, rozanolixizumab therapy, and myasthenia gravis. The most recent prescribing information was also used for information relating to the drug and for identification of pertinent studies.Study Selection/Data Extraction:Phase I, II, and III randomized controlled trials were all eligible for inclusion. Meeting abstracts and articles focusing on the use of rozanolixizumab or any indication other than generalized myasthenia gravis were excluded from this article.Data Synthesis:Food and Drug Administration approval of rozanolixizumab is based on the phase III MycarinG study in patients with generalized myasthenia gravis. A phase II trial explored initial clinical efficacy and safety pertaining to the dose and frequency of rozanolixizumab across 2 treatment periods in patients with moderate to severe myasthenia gravis.Relevance to Patient Care and Clinical Practice in Comparison to Existing Agents:Rozanolixizumab is the first therapy approved to treat patients positive for both types of antibodies, anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase, in generalized myasthenia gravis.Conclusion/Relevance:The approval of rozanolixizumab represents an advancement in therapy for generalized myasthenia gravis. The provision of individualized, targeted, and well-tolerated treatment is valuable for the patients whose myasthenia gravis is not well controlled and who are seeking a medication with a rapid onset of action to improve their symptoms and overall quality of life. Citation: Annals of Pharmacotherapy PubDate: 2024-03-27T09:38:49Z DOI: 10.1177/10600280241239048
- Low-Intensity Statin Plus Ezetimibe Versus Moderate-Intensity Statin for
Primary Prevention: A Population-Based Retrospective Cohort Study in Asian Population-
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Authors: Minji Jung, Beom-Jin Lee, Sukhyang Lee, Jaekyu Shin Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:While moderate-intensity statin therapy is recommended for primary prevention, statins may not be utilized at a recommended intensity due to dose-dependent adverse events, especially in an Asian population. However, evidence supporting the use of low-intensity statins in primary prevention is limited.Objective:We sought to compare clinical outcomes between a low-intensity statin plus ezetimibe and a moderate-intensity statin for primary prevention.Methods:This population-based retrospective cohort study used the Korean nationwide claims database (2002-2019). We included adults without atherosclerotic cardiovascular diseases who received moderate-intensity statins or low-intensity statins plus ezetimibe. The primary outcome was a composite of all-cause mortality, myocardial infarction, and ischemic stroke. The safety outcomes were liver and muscle injuries and new-onset diabetes mellitus (DM). We used standardized inverse probability of treatment weighting (sIPTW) and propensity score matching (PSM).Results:In the sIPTW model, 1717 and 36 683 patients used a low-intensity statin plus ezetimibe and a moderate-intensity statin, respectively. In the PSM model, each group included 1687 patients. Compared with moderate-intensity statin use, low-intensity statin plus ezetimibe use showed similar risks of the primary outcome (hazard ratio [HR] = 0.92, 95% CI = 0.81-1.12 in sIPTW and HR = 1.16, 95% CI = 0.87-1.56 in PSM model). Low-intensity statin plus ezetimibe use was associated with decreased risks of liver and muscle injuries (subHR [sHR] = 0.84, 95% CI = 0.74-0.96 and sHR = 0.87, 95% CI = 0.77-0.97 in sIPTW; sHR = 0.84, 95% CI = 0.72, 0.96 and sHR = 0.82, 95% CI = 0.72-0.94 in PSM model, respectively). For new-onset DM and hospitalization of liver and muscle injuries, no difference was observed.Conclusion and Relevance:Low-intensity statin plus ezetimibe may be an alternative to moderate-intensity statin for primary prevention. Our findings provide evidence on safety and efficacy of statin therapy in Asian population. Citation: Annals of Pharmacotherapy PubDate: 2024-03-20T12:07:36Z DOI: 10.1177/10600280241237781
- Evaluation of Clinical Outcomes Associated With Phenobarbital With Taper
Compared to No Taper for the Management of Alcohol Withdrawal Syndrome-
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Authors: Matthew Thaller, Adrian Wong, Tuyen Yankama, Ifeoma Mary Eche, Pansy Elsamadisi Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Phenobarbital (PHB) has been shown to be an effective treatment of alcohol withdrawal syndrome (AWS), with multiple dosing strategies used (e.g., single-dose and symptom-triggered). Studies have often used tapered doses, typically following a front-loaded dose, despite PHB’s long half-life which should lead to an ability to auto-taper.Objective:The purpose of this study was to compare clinical outcomes associated with two PHB dosing strategies (taper [T], no taper [NT]) for AWS.Methods:This retrospective cohort study compared adult patients admitted to the ICU from October 2017 to May 2019 who received an initial loading dose of PHB for AWS. The use of PHB was at the discretion of the clinician per our institutional guidelines. Prior to November 2018, patients were prescribed a PHB taper, while after this period, the taper was no longer recommended. The primary outcome was the proportion of patients requiring rescue PHB or adjunctive medications for AWS. Secondary outcomes included number of adjunctive agents used, prevalence of severe manifestations of AWS, ICU and hospital lengths of stay, and incidence of potentially significant drug interactions.Results:A total of 172 patients were included (T: n = 81, NT: n = 91). Baseline characteristics were similar between groups, including history of severe AWS and cumulative benzodiazepine dose pre-PHB. There was no difference in the primary outcome between groups (T: 70.4% vs NT: 59.3%, P = 0.152). The median number of adjunctive agents per patient, severe manifestations, and ICU and hospital length of stay did not differ between groups. Twenty-five patients (14.5%) had potentially significant drug interactions.Conclusion and Relevance:The use of a PHB loading dose without a taper may be comparable to a taper strategy on clinical outcomes. Prospective studies are needed to further delineate the optimal dose of PHB for AWS. Citation: Annals of Pharmacotherapy PubDate: 2024-03-19T12:59:41Z DOI: 10.1177/10600280241236412
- Cytomegalovirus Treatment in Solid Organ Transplantation: An Update on
Current Approaches-
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Authors: Karen L. Hardinger, Daniel C. Brennan Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:The article reviews the safety and efficacy of treatments for cytomegalovirus (CMV) in solid organ transplantation.Data Sources:A literature review was conducted in PubMed, MEDLINE, and Clinicaltrials.gov from database inception through January 2024, using terms CMV, therapy, and solid organ transplantation.Study Selection and Data Extraction:Clinical trials, meta-analyses, cohort studies, case reports, and guidelines were included. Letters to the editor, reviews, and commentaries were excluded.Data Synthesis:After abstract screening and full-text review of 728 citations for eligibility, 53 were included. Valganciclovir and intravenous ganciclovir are drugs of choice for CMV management and, until recently, the availability of alternative options has been restricted due to toxicity. For instance, foscarnet and cidofovir serve as second-line agents due to potential bone marrow and renal toxicity. In patients with refractory or resistant CMV, maribavir, a novel oral agent, has proven efficacy and a lower adverse effect profile. However, in refractory or resistant CMV, foscarnet and cidofovir are preferred in invasive disease (CMV gastritis, CMV retinitis, and CMV encephalitis), high viral loads, and inability to tolerate oral preparations.Relevance to Patient Care and Clinical Practice:Consensus guidelines have not been revised since approval of novel antivirals in solid organ transplantation. Valganciclovir and ganciclovir remain drugs of choice for initial CMV therapy. Foscarnet, cidofovir, and maribavir are treatments for refractory or resistant-CMV.Conclusions:Selection of CMV antiviral treatment should be determined by patient-specific factors, including severity of illness, resistant or refractory disease, dose-limiting adverse effects, and the preferred route of administration. Citation: Annals of Pharmacotherapy PubDate: 2024-03-19T12:57:39Z DOI: 10.1177/10600280241237534
- The Effect of Albumin Replacement on Vasopressor Duration in Septic Shock
in Patients With Hypoalbuminemia-
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Authors: Jacob P. Counts, Joshua Arnold, Sara Atyia, Stella Ogake, Rachel M. Smith, Bruce Doepker Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:The use of albumin resuscitation in septic shock is only recommended in patients who have received large volumes of crystalloid resuscitation regardless of serum albumin concentration. The role of albumin is still largely debated and evidence to support its use still lacking.Objective:The objective of this study was to evaluate whether albumin replacement increases the number of vasopressor-free days in patients with septic shock and hypoalbuminemia.Methods:A retrospective analysis was conducted to assess the effect of albumin replacement in septic shock. Hypoalbuminemic patients with septic shock who received albumin were retrospectively compared with a cohort who did not. The primary outcome was number of vasopressor-free days at day 14 from shock presentation, which was analyzed using an adjusted linear regression model to adjust for confounders.Results:There was no difference in vasopressor-free days at day 14 in patients who received albumin versus those who did not, after adjusting for confounders of exposure (0.50, 95% CI = −0.97 to 1.97; P = 0.502). There also was no difference in secondary outcomes except for need for invasive mechanical ventilation (MV), which was significantly lower in patients who received albumin (61 [54.4%] vs 88 [67.7%]; P = 0.035).Conclusions and Relevance:We observed no difference in vasopressor-free days at day 14 in patients with hypoalbuminemia who received albumin compared with those who did not. However, patients who received albumin required significantly less MV although further studies are warranted to assess this effect. Citation: Annals of Pharmacotherapy PubDate: 2024-03-15T05:02:54Z DOI: 10.1177/10600280241236507
- Incidence of Hypertriglyceridemia in Patients on Propofol, Clevidipine, or
Both-
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Authors: Christopher B. Johns, Travis W. Fleming, Skyler R. Brown, Rebekah B. Black, A. Shaun Rowe Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Propofol and clevidipine (PC) are commonly used in the treatment of critically ill patients. While both medications are lipid emulsions, there is limited evidence concerning the incidence of hypertriglyceridemia (HTG) when these agents are used individually or concurrently.Objective:The objective of this study is to determine the effects of propofol, clevidipine, or concurrent PC on triglycerides (TGs) and related outcomes in critically ill adults.Methods:This was a retrospective cohort study conducted at an academic medical center. Patients were included if they received ≥24 hours of continuous propofol and/or clevidipine. Excluded were those without TG levels after ≥24 hours of infusion, baseline HTG, acute pancreatitis at admission, or receiving total parenteral nutrition with lipids. The primary outcome was incidence of HTG (defined as a TG level>400 mg/dL). Secondary outcomes included median and peak TG levels, hospital length of stay, intensive care unit length of stay, total lipid infused, time to peak TG level, peak lipase level, and development of pancreatitis.Results:In total, 190 patients were studied: 109 in the propofol group, 50 in the clevidipine group, and 31 in the PC group. Incidence of HTG was similar (19 [17.4%] vs 6 [12%] vs 4 [12.9%] patients, P = 0.6246). Peak and median TG levels were similar for propofol, clevidipine, and PC groups (216 mg/dL vs 189.5 mg/dL vs 205 mg/dL, P = 0.7069; 177 mg/dL vs 185.5 mg/dL vs 177 mg/dL, P = 0.6791).Conclusions and Relevance:There was a similar incidence of HTG in all groups. The results of this study suggest that the concurrent use of PC should not modify the frequency of TG level monitoring. Citation: Annals of Pharmacotherapy PubDate: 2024-02-26T12:53:32Z DOI: 10.1177/10600280241232991
- Safety Profile of Selective Serotonin Reuptake Inhibitors in Real-World
Settings: A Pharmacovigilance Study Based on FDA Adverse Event Reporting System-
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Authors: Yi Zhao, Yuzhou Zhang, Lin Yang, Kanghuai Zhang, Sha Li Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Selective serotonin reuptake inhibitors (SSRIs) are the most frequently prescribed agents to treat depression. Considering the growth in antidepressant prescription rates, SSRI-induced adverse events (AEs) need to be comprehensively clarified.Objective:This study was to investigate safety profiles and potential AEs associated with SSRIs using the Food and Drug Administration Adverse Event Reporting System (FAERS).Methods:A retrospective pharmacovigilance analysis was conducted using the FAERS database, with Open Vigil 2.1 used for data extraction. The study included cases from the marketing date of each SSRI (ie, citalopram, escitalopram, fluoxetine, paroxetine, fluvoxamine, and sertraline) to April 30, 2023. We employed the reporting odds ratio and Bayesian confidence propagation neural network as analytical tools to assess the association between SSRIs and AEs. The Medical Dictionary for Regulatory Activities was used to standardize the definition of AEs. AE classification was achieved using system organ classes (SOCs).Results:Overall, 427 655 AE reports were identified for the 6 SSRIs, primarily associated with 25 SOCs, including psychiatric, nervous system, congenital, familial, genetic, cardiac, and reproductive disorders. Notably, sertraline (n = 967) and fluvoxamine (n = 169) exhibited the highest and lowest signal frequencies, respectively. All SSRIs had relatively strong signals related to congenital, psychiatric, and nervous disorders.Conclusions and relevance:Most of our findings are consistent with those reported previously, but some AEs were not previously identified. However, AEs attributed to SSRIs remain ambiguous, warranting further validation. Applying data-mining methods to the FAERS database can provide additional insights that can assist in appropriately utilizing SSRIs. Citation: Annals of Pharmacotherapy PubDate: 2024-02-26T12:51:13Z DOI: 10.1177/10600280241231116
- Sugammadex Use Outside of the Postoperative Setting
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Authors: Hayley T. Gartner, Megan A. Rech Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Sugammadex rapidly reverses the nondepolarizing neuromuscular blocking agents (NMBAs) rocuronium and vecuronium. The role of sugammadex is not well-defined outside of the postoperative setting.Objective:This study aims to describe sugammadex use outside the postoperative setting for the reversal of nondepolarizing NMBAs.Methods:This was a single-center, retrospective cohort study conducted in patients who received sugammadex outside of the postoperative setting at an academic medical center between June 2016 and November 2022. The primary outcome was the effect of sugammadex use for rocuronium reversal, defined as any increase in train-of-four (TOF) after sugammadex administration and/or progress note documentation if TOF was unavailable. Secondary outcomes included adverse events and documentation of contraceptive counseling in patients taking hormonal contraceptives with child-bearing ability.Results:A total of 14 383 patients received sugammadex during the study period. Of those patients, 39 (0.3%) were outside of the postoperative setting for the reversal of rocuronium and included in the study. Twenty-nine (74%) patients had an increase in TOF after sugammadex administration and/or progress note documentation if TOF was unavailable. Ten (26%) patients lacked documentation regarding the effect of sugammadex. No adverse reactions were reported. Three (8%) patients included in the study were of child-bearing ability, and 1 of the 3 patients was counseled on using an alternative method of contraception following sugammadex administration.Conclusion and Relevance:There is a paucity of literature for the use of sugammadex outside of the postoperative setting. This study found that while the use of sugammadex was rare, overall, it was safe and well-tolerated. Citation: Annals of Pharmacotherapy PubDate: 2024-02-23T05:06:49Z DOI: 10.1177/10600280241232660
- Eye Drop Quality Issues: Can the FDA See This One Through'
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Authors: Lyla R. White, C. Michael White Abstract: Annals of Pharmacotherapy, Ahead of Print. The Food and Drug Administration (FDA) has long suffered from a lack of resources limiting their inspection capacity. They have fallen behind on proactive surveillance inspections of foreign manufacturing sites, relying instead on for-cause inspections after a problem has been discovered. Over-the-counter (OTC) products are especially vulnerable because the FDA considers them lower priority. This issue recently made big news after improperly manufactured OTC eye drops harmed users across the country, in some cases causing blindness. To prevent future harm to Americans, it is imperative that the FDA receives enough resources to keep up with their routine inspections. Citation: Annals of Pharmacotherapy PubDate: 2024-02-21T12:47:35Z DOI: 10.1177/10600280241233255
- Preoperative Amiodarone and Primary Graft Dysfunction in Heart
Transplantation-
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Authors: Abigail Servais, Scott Lundgren, Stephanie Bowman, Douglas Stoller, Adam Burdorf, Marshall Hyden, Brian Lowes, Ronald Zolty, Don Klepser, Heidi Brink Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Preoperative amiodarone effects on postorthotopic heart transplant (OHT) outcomes remain controversial.Objective:The purpose of this study was to determine the effect of cumulative pre-OHT amiodarone exposure on severe primary graft dysfunction (PGD).Methods:We retrospectively reviewed adult OHT recipients between August 2012 and June 2018. Primary outcome was severe PGD in patients receiving amiodarone at 3, 6, and 12 months prior to OHT compared with those not receiving amiodarone. Secondary outcomes included intensive care unit (ICU) and hospital length of stay, duration of mechanical ventilation, early graft failure (EGF), mortality at 3, 6, and 12 months post-OHT, and 30-day incidence of postoperative tachyarrhythmias, bradycardia, permanent pacemaker implantation, and rejection.Results:Incidence of severe PGD was 12.5% in those who received amiodarone compared to 6.8% in those who did not (14 vs 6, P = 0.18). Cumulative preoperative amiodarone significantly increased the odds of severe PGD at 3 months (odds ratio [OR]: 1.03; 95% confidence interval [CI]: 1.001-1.06; P = 0.044) and 6 months (OR: 1.02, 95% CI: 1.003-1.044; P = 0.024) in a multivariate logistic regression. Patients on amiodarone had significantly higher rates of postoperative bradycardia (13.4% vs 4.5%, P = 0.03).Conclusion and Relevance:A trend toward increased PGD was present in patients receiving preoperative amiodarone. This finding combined with the regression showing significantly increased odds of PGD with increasing 3 and 6 month cumulative amiodarone dose is clinically concerning. Escalation of care with pacemaker implantation was required more frequently in patients on pre-OHT amiodarone. Citation: Annals of Pharmacotherapy PubDate: 2024-02-16T04:58:50Z DOI: 10.1177/10600280241232032
- Exploring Safety in Gender-Affirming Hormonal Treatments: An Observational
Study on Adverse Drug Events Using the Food and Drug Administration Adverse Event Reporting System Database-
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Authors: Ainhoa Gomez-Lumbreras, Lorenzo Villa-Zapata Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:People with gender dysphoria are treated with hormone therapy for gender reassignment. The indication of this therapy was initially for the opposite sex, and information on potential adverse drug reaction (ADR) is lacking.Objective:To describe ADR associated with gender transition medication in transgender individuals reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods:Data from the FAERS database up to June 2023 were examined, focusing on reports of gender transition medication use in the context of gender dysphoria. The ADRs were categorized using the Medical Dictionary for Regulatory Activities at both Preferred Term and System Organ Class (SOC) levels. Descriptive statistics summarized report counts, medication types, indications, and ADR severity.Results:For individuals assigned female at birth undergoing gender transition to male (transgender men), 82 reports (230 ADRs) were analyzed, with an average age of 29.5 years. Transgender hormonal therapy was cited in 72% of reports, predominantly from the United States (67.1%). A striking 88% were categorized as serious ADRs, primarily SOC injury, poisoning, and procedural complications (26.5%), followed by psychiatric disorders (14.8%) and nervous system disorders (12.2%). Among those assigned sex male at birth transitioning to female (transgender women) (81 reports, 237 ADRs), mean age was 33.3 years, with 58% indicating use for gender dysphoria. A significant proportion (53.6%) were serious ADRs, primarily SOC: injury, poisoning, and procedural complications (26.6%).Conclusions and Relevance:The FAERS data reveal significant ADRs in transgender individuals using hormone therapy, sometimes unintended for their recipient gender. Population-level studies are crucial to enhance transgender health care. Spontaneous surveillance databases like FAERS illuminate off-label ADRs, urging health care providers to approach hormone therapies with informed caution. Citation: Annals of Pharmacotherapy PubDate: 2024-02-13T06:16:28Z DOI: 10.1177/10600280241231612
- Evaluation of Short Versus Long Courses of Antibiotics in Critically Ill
Patients With Gram-Negative Bloodstream Infections-
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Authors: Daniel T. Anderson, Divisha Sharma, Aaron M. Chase, Zoheb Irshad Sulaiman, August H. Anderson, Ashley L. Huggett, Joshua Eudy Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Short courses of antibiotics (7-10 days) are effective for uncomplicated gram-negative bloodstream infections (GN-BSI). However, prior studies have been limited to small cohorts of critically ill patients.Objective:The objective of this study was to evaluate the safety and efficacy of short courses of therapy compared with longer courses in patients admitted to the intensive care unit (ICU) with GN-BSI.Methods:Propensity-matched, retrospective cohort study of critically ill patients with GN-BSI. The primary outcome was a composite of 30-day mortality or 60-day relapse. Secondary endpoints were components of the composite, 30-day relapse, cure with or without adverse drug events (ADE), and ADEs. Regression analysis was performed to identify factors predictive of the composite outcome.Results:225 patients were included in the propensity analysis, 145 in the long cohort and 80 in the short cohort. The primary outcome occurred in 3.8% of patients in the short group and 9.0% of patients in the long group (P = 0.24). There was no difference in 30-day mortality (3.8% vs 5.5%, P = 0.79), 60-day relapse (0% vs 3.4%, P = 0.23), or 30-day readmission (20% vs 22.8%, P = 0.76). ADEs were more common in the long group (47.2% vs 34.1%, OR 1.7, 95% CI 1.04-2.9), primarily attributable to diarrhea.Conclusion and Relevance:In critically ill patients with GN-BSI, there were no efficacy outcome differences in patients treated with a short course of antibiotics compared with longer. However, patients in the short group were less likely to experience ADE. These findings suggest that short courses of antibiotics are effective for GN-BSI in critically ill patients. Citation: Annals of Pharmacotherapy PubDate: 2024-02-13T06:10:09Z DOI: 10.1177/10600280241231611
- Mirikizumab: A New Therapeutic Option for the Treatment of Ulcerative
Colitis-
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Authors: David Choi, Hilary Sheridan, Shubha Bhat Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To review the pharmacologic and clinical profile of mirikizumab in the treatment of moderate to severe ulcerative colitis (UC).Data sources:A PubMed search was performed from inception to December 2023 using keywords mirikizumab, interleukin-23 inhibitor, and UC. Information was also obtained from package inserts as well as published abstracts.Study selection and data extraction:Phase 3 studies plus relevant literature on mirikizumab pharmacologic and clinical profile were reviewed.Data synthesis:Mirikizumab approval was based on LUCENT-1 and LUCENT-2. In the phase 3 studies involving patients with moderate to severe UC, mirikizumab, when compared to placebo, resulted in clinical remission in a significantly higher proportion of patients in both the induction and maintenance phase. In addition, mirikizumab met the secondary endpoints of alternate definition of clinical remission, endoscopic remission, glucocorticoid-free clinical remission, histologic-endoscopic mucosal remission, and improvement in bowel urgency status, bowel-urgency remission, and maintenance of clinical remission. Common adverse events noted include infection (15.1%), injection-site reaction (8.7%), nasopharyngitis (7.2%), and headache (3.3%).Relevance to patient care and clinical practice in comparison to existing agents:Mirikizumab is the first selective interleukin 23 (IL-23) inhibitor approved for UC. Additional studies are required to determine how to position mirikizumab in both biologic-naïve and biologic-experienced patients with moderate to severe UC.Conclusion:Mirikizumab provides a novel mechanism of action for the treatment of moderate to severe UC and is another welcomed treatment advance in the treatment arsenal, providing a more selective mechanism of action while maintaining a comparable safety profile. Citation: Annals of Pharmacotherapy PubDate: 2024-02-12T11:09:49Z DOI: 10.1177/10600280241229742
- Real-World Incidence and Severity of Hypertension Caused by Abiraterone
Acetate in Patients With Metastatic Prostate Cancer-
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Authors: Brian Lam, Jo E. Rodgers, Benyam Muluneh, Darrian Proco, Young E. Whang, Katherine P. Morgan Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Abiraterone acetate (AA) is used in treatment of patients with metastatic prostate cancer. Despite the survival advantage, AA is associated with hypertension due to mineralocorticoid excess syndrome.Objective:We conducted a single-center retrospective analysis to evaluate the real-world incidence and severity of AA-induced hypertension.Methods:Electronic health records were used to collect baseline characteristics and prostate cancer history. Patient data, including blood pressure at each 4 (±2)-week interval, were collected for 24 weeks after the initiation of AA therapy. The primary endpoint was the incidence and severity of AA-induced hypertension. The secondary endpoints include effect of different prednisone dosing regimens and prostate cancer types on hypertensive incidence and the impact of clinical pharmacists’ involvement in managing AA-induced hypertension.Results:A total of 142 patients who met our inclusion criteria received AA for metastatic prostate cancer, 73 (51.4%) with metastatic castration-resistant prostate cancer (mCRPC), and 69 (48.6%) with metastatic castration-sensitive prostate cancer (mCSPC). Of all, 43.7% experienced all-grade hypertension, and 28.2% experienced grade 3-4 hypertension. There was no difference in incidence of hypertension between patients receiving 5 mg of prednisone daily and those receiving 5 mg of prednisone twice daily. All-grade hypertension occurred in 39.7% of mCRPC and 47.8% of mCSPC patients (P = 0.33). Thirty-two percent of patients were actively managed by a clinical pharmacist and had an overall trend of reduced hypertension severity after 12 weeks.Conclusion and relevance:This single-center, retrospective cohort study found that real-world metastatic prostate cancer patients who received AA had substantially higher incidence and severity of hypertension compared with clinical trials regardless of prednisone dose. In patients with mCRPC and mCSPC, the role of prednisone dose in hypertension incidence and severity warrants further investigation. Overall, results indicate the need for closely monitoring hypertension and optimization of anti-hypertensive therapy by multidisciplinary teams in metastatic prostate cancer patients receiving AA. Citation: Annals of Pharmacotherapy PubDate: 2024-02-12T11:08:18Z DOI: 10.1177/10600280231223213
- The Impact of Glycemic Control on Sodium-Glucose Co-Transporter 2
Inhibitor–Associated Genitourinary Infections-
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Authors: Anthony Gerber, Victoria Rupp, Natalia Ryabenkova, Nataliya Mikhelzon Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Patients with type 2 diabetes (T2D) are at an increased risk of genital urinary (GU) infections, with the risk increasing with higher A1Cs. Given the broad adoption of sodium-glucose co-transporter 2 inhibitors (SGLT2is) in patients with T2D, both providers and patients need to be aware of common adverse effects associated with these medications, specifically GU infections. However trials involving SGLT2is looked at patients with an average A1C of less than 9%, and thus, the incidence of GU infections may not truly reflect the general diabetic population.Objective:The purpose of this study is to assess the association between GU infections in patients started on SGLT2is and A1C levels.Methods:A retrospective study was conducted on patients seen in an adult, primary care clinic, at New York City Health and Hospitals, South Brooklyn Health. Men and nonpregnant, nonlactating women>18 years old with a diagnosis of T2D who were initiated on an SGLT2i between January 2018 and January 2023 were included in the analysis. The primary endpoint is to compare the risk of GU infections in patients with T2D who were started on SGLT2is, regardless of dose, with hemoglobin A1C of>9% to those with hemoglobin A1C 9% compared with those with an A1C Citation: Annals of Pharmacotherapy PubDate: 2024-02-07T07:12:02Z DOI: 10.1177/10600280241227973
- Clinical Response to Third-Line Angiotensin-II vs Epinephrine in Septic
Shock: A Propensity-Matched Cohort Study-
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Authors: Caitlyn R. Blankenship, Kevin D. Betthauser, Laura N. Hencken, Julie A. Maamari, Jenna Goetz, Bria D. Giacomino, Gabrielle A. Gibson Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:The appropriate third-line vasopressor in septic shock patients receiving norepinephrine and vasopressin is unknown. Angiotensin-II (AT-II) offers a unique mechanism of action to traditionally used vasopressors in septic shock.Objective:The objective of this study was to compare the clinical efficacy and safety of third-line AT-II to epinephrine in patients with septic shock.Methods:A single-center, retrospective cohort study of critically ill patients was performed between April 1, 2019 and July 31, 2022. Propensity-matched (2:1) analysis compared adults with septic shock who received third-line AT-II to controls who received epinephrine following norepinephrine and vasopressin. The primary outcome was clinical response 24 hours after third-line vasopressor initiation. Additional efficacy and safety outcomes were investigated.Results:Twenty-three AT-II patients were compared with 46 epinephrine patients. 47.8% of AT-II patients observed a clinical response at hour 24 compared with 28.3% of epinephrine patients (P = 0.12). In-hospital mortality (65.2% vs 73.9%, P = 0.45), cardiac arrhythmias (26.1% vs 26.1%, P = 0.21), and thromboembolism (4.3% vs 2.2%, P = 0.61) were not observed to be statistically different between groups.Conclusions and relevance:Administration of AT-II as a third-line vasopressor agent in septic shock patients was not associated with significantly improved clinical response at hour 24 compared with epinephrine. Although underpowered to detect meaningful differences, the clinical observations of this study warrant consideration and further investigation of AT-II as a third-line vasopressor in septic shock. Citation: Annals of Pharmacotherapy PubDate: 2024-02-02T06:43:18Z DOI: 10.1177/10600280231226132
- Evaluation of a Pharmacist-Led Implementation of Standardized Medication
Administration Times for Inpatients Receiving Hemodialysis-
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Authors: Abbie L. Blunier, Megan R. Cheatham, Karishma S. Deodhar, Christopher A. Geik, Todd A. Walroth, Jessica A. Whitten, Christie M. Davis Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Missed medication doses are a common and often preventable medication-related error that have been associated with an increased length of stay and mortality. Hemodialysis is a common, relatively predictable reason that patients are unavailable, resulting in missed doses.Objective:To evaluate the implications of a pharmacist-led intervention to standardize the medication administration times for patients requiring hemodialysis who were prescribed antihypertensives, antiepileptics, apixaban, and/or antimicrobials.Methods:A retrospective preanalysis and postanalysis of a pharmacist-led intervention were performed at a single-center, safety net hospital. Patients receiving dialysis and prescribed one of the targeted medications were included. The primary endpoint was the composite of missed and delayed doses.Results:A total of 25 patients receiving 126 dialysis sessions in the preintervention group and 29 patients receiving 80 dialysis sessions in the postintervention group were included for analysis. For the primary endpoint, 118 (18%) versus 57 (9.3%) doses were missed or delayed in the preintervention versus postintervention group, respectively (P < 0.001). The primary endpoint was driven by fewer delayed doses in the postgroup. The number of antimicrobials given on a correct schedule increased in the postintervention group (98.3% vs 99.1%, P = 0.044).Conclusion and Relevance:A pharmacist-led intervention for standard medication administration times in patients requiring hemodialysis increased the number of prescribed medication doses given and given on time. The intervention also led to more antimicrobials administered at appropriate times relative to dialysis sessions. Citation: Annals of Pharmacotherapy PubDate: 2024-01-31T10:13:30Z DOI: 10.1177/10600280231220079
- Monoclonal Antibody Infusions for Outpatient Management of Mild-Moderate
COVID-19-
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Authors: Hannah B. Knox, Lisa A. Dykes, Lancer A. Scott, Bradley C. Presley, Lara C. Lambert Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:The COVID-19 pandemic has led to a rapid, exponential increase in hospitalizations and morbidity/mortality. In November 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) permitting administration of the first monoclonal antibodies (mAb) for outpatient treatment of COVID-19. Early data showed a reduction in COVID-19-related hospitalizations with few adverse events. However, since these treatments are only authorized under an EUA, real-world data are minimal.Objective:To assess efficacy and safety of mAbs in a veteran population.Methods:This retrospective study analyzed veterans at the Ralph H. Johnson Veterans Affairs Health Care System with mild-moderate COVID-19 and screened for mAb eligibility between December 1, 2020, and October 31, 2021. The primary outcome was hospitalizations and/or emergency department (ED) visits within 30 days. Secondary outcomes included 30-day mortality and post-COVID-19 conditions. Adverse events were also evaluated. Outcomes were compared between mAb-treated patients and eligible veterans who were not treated.Results:There were 296 and 275 veterans in the mAb and control groups, respectively. No statistically significant difference was found for the primary outcome overall (25.7% vs 25.1%; P = 0.87), nor for COVID-19-related return visits or hospitalizations (13.9% v. 16%; P = 0.4). However, the mAb group had more return ED visits (P = 0.35), and the control group had significantly more hospitalizations (P = 0.02). Vaccinated veterans who received an mAb had fewer return visits and hospitalizations (P = 0.01). More mAb-treated veterans experienced post-COVID-19 conditions. No difference in mortality was found. Four nonsevere adverse events occurred after the mAb therapy.Conclusion and relevance:Overall, the mAbs appeared safe and effective. Sicker, higher-risk mAb-treated veterans faired similarly to less-sick, high-risk veterans not treated. Those who were vaccinated seemed to benefit the most from mAb therapy. Future prospective studies with more matched groups are needed to assess full benefits and risks of mAbs shown to neutralize the predominant variants. Citation: Annals of Pharmacotherapy PubDate: 2024-01-30T09:17:49Z DOI: 10.1177/10600280231222465
- Epidemiology of Vancomycin in Combination With
Piperacillin/Tazobactam-Associated Acute Kidney Injury in Children: A Systematic Review and Meta-analysis-
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Authors: Miao Zhang, Liang Huang, Yu Zhu, Linan Zeng, Zhi-Jun Jia, Guo Cheng, Hailong Li, Lingli Zhang Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Several studies have shown that vancomycin combined with piperacillin/tazobactam (VPT) increased the risk of acute kidney injury (AKI) compared with other antibiotics in children. However, the epidemiology of VPT-associated AKI in children is unknown.Objective:To evaluate the incidence and risk factors of VPT-associated AKI in children.Data sources:Literature databases of PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Database, WanFang Database, and China Biology Medicine Disc were searched from inception to November 2023. References of included studies were also manually checked.Study selection and data extraction:Two independent reviewers selected studies, extracted data, and quality assessment. Meta-analyses were performed to quantify the incidence and risk factors of VPT-associated AKI in children.Data synthesis:Sixteen cohort studies were identified. Overall, the incidence of VPT-associated AKI in children was 24.3% (95% CI: 17.9%-30.6%). The incidence of VPT-associated AKI in critically ill children (26.6%) was higher than that in noncritically ill children (10.9%). Moreover, higher serum vancomycin trough concentration (>15 mg/L), use of vasopressors, combination of nephrotoxins and intensive care unit admission were risk factors for VPT-associated AKI in children (P Citation: Annals of Pharmacotherapy PubDate: 2024-01-27T12:50:24Z DOI: 10.1177/10600280231220379
- Documentation of the Patient Characteristics Morbid Obesity and Bariatric
Surgery in the Hospital Information System and the Influence on the Number of Medication-Related Problems-
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Authors: Jurjen S. Kingma, Iris A. M. Brenkman, Marcel P. H. van den Broek, Patricia M. L.A. van den Bemt, Karin Janssen, Catherijne A. J. Knibbe, Desirée M. T. Burgers Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:As a result of pharmacokinetic changes, individuals with morbid obesity and/or with bariatric surgery may require dose adjustments, additional monitoring or medication should be avoided. Clinical decision support (CDS) may provide automated alerts enabling correct prescribing but requires documentation of these patient characteristics in the Hospital Information System (HIS) to prevent medication-related problems (MRPs).Objective:The primary objective is to determine the proportion of patients with documentation of the patient characteristics morbid obesity and bariatric surgery in the HIS. The secondary objective is to compare the proportion of patients with an MRP in the group with versus without documentation. Also, the type and severity of MRPs and the medication involved are determined.Methods:A prospective cohort study was performed. Patients admitted to the hospital were identified as morbidly obese and/or with bariatric surgery. In the identified patients, the proportion of patients with documentation of the patient characteristics in the HIS was evaluated as primary outcome. Subsequently, patient records were reviewed for MRPs, which were categorized and associated medication was registered. For the primary objective, descriptive statistics was used. For the secondary outcome, the Fisher’s exact test was used.Results:In 43 (21.4%, 95% confidence interval [CI]: 15.7%-27.1%) of 201 included patient (113 morbid obesity, 70 bariatric surgery and 18 both), the patient characteristics were documented. An MRP occurred in 2.3% versus 13.9% (P = 0.032) of patients with and without documentation, respectively. The most common MRP was underdosing in morbid obesity, while in patients with bariatric surgery it was prescription of contra-indicated medication.Conclusion and relevance:The proportion of patients with documentation of the patient characteristics bariatric surgery and/or morbid obesity in the HIS is low, which appears to be associated with more MRPs. To improve medication safety, it is important to document these patient characteristics. Citation: Annals of Pharmacotherapy PubDate: 2024-01-25T06:02:48Z DOI: 10.1177/10600280231226243
- Etrasimod: A Sphingosine-1-Phosphate Receptor Modulator for the Treatment
of Ulcerative Colitis-
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Authors: David Choi, Michelle Becker, Marina Ivanov, Shubha Bhat Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:To review the pharmacologic and clinical profile of etrasimod in the treatment of ulcerative colitis (UC).Data sources:A PubMed search was conducted from inception to November 2023 using the keywords etrasimod, ulcerative colitis, and sphingosine-1-phosphate receptor modulator. Information was also obtained from published abstracts and package insert.Study selection and data extraction:Phase 2 and 3 studies plus relevant literature on etrasimod pharmacologic and clinical profile were reviewed.Data synthesis:Per ELEVATE, 2 phase 3 studies, a higher proportion of patients with moderately to severely active UC achieved clinical remission in the induction and maintenance phase with etrasimod compared with placebo. In addition, a higher proportion of patients achieved secondary endpoints of clinical response, endoscopic improvement-histologic remission, corticosteroid-free remission, and endoscopic improvement with etrasimod vs placebo. Common adverse events include anemia and headache.Relevance to patient care and clinical practice in comparison with existing drugs:Etrasimod is now the second orally administered sphingosine-1-phosphate modulator approved for UC, providing patients with additional treatment options. Efficacy rates of this treatment are in line with other UC medication options. Similar to other sphingosine-1-phosphate receptor modulators, various assessments are required at baseline and during treatment to ensure safe and appropriate use.Conclusion:Etrasimod is another possibility in the armamentarium of UC treatment, providing patients with more oral medication options. Prior to treatment initiation, several assessments relating to safety, drug interactions, and pharmacogenomics factors are advised. Citation: Annals of Pharmacotherapy PubDate: 2024-01-23T11:48:26Z DOI: 10.1177/10600280231225770
- Impact of a Divided Phenobarbital Load and Taper Compared With Lorazepam
Symptom Triggered Therapy in Hospitalized Patients-
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Authors: Alyson M. Esteves, Matthew C. Buchfellner, Brooke M. Holmes, Joseph A. Berndsen, Matthew A. Roginski Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Benzodiazepines are the preferred treatment for alcohol withdrawal. Phenobarbital is an alternative in the setting of prescriber expertise or benzodiazepine contraindication.Objective:To evaluate the efficacy and safety of a phenobarbital dosing strategy aimed at treating a spectrum of alcohol withdrawal symptoms across various patient populations.Methods:Retrospective review of patients admitted with concerns of alcohol withdrawal between May 2018 and November 2022. Patients were separated into a before-after cohort of lorazepam or phenobarbital. The primary outcome was hospital length of stay (LOS). Secondary outcomes were intensive care unit (ICU) LOS, escalation of respiratory support, increased level of care (LOC), and incidence of delirium tremens and/or seizures.Results:Two hundred and seventy-seven patients received lorazepam and 198 received phenobarbital. Hospital LOS was longer in the phenobarbital cohort compared with the lorazepam cohort (6.9 vs 9.3 days). There was no difference in ICU LOS. Level of care increases were fewer in the phenobarbital cohort (4 events vs 19 events). There were higher rates of non-invasive respiratory interventions in the lorazepam cohort and higher rates of mechanical ventilation in the phenobarbital cohort. Utilization of phenobarbital was attributed to a reduction in delirium tremens and seizures.Conclusion and Relevance:This study is novel because of the broad application of a phenobarbital order set across multiple levels of care and patient admission diagnoses. A risk targeted split load intravenous phenobarbital order set can safely be administered to patients with fewer escalations of care, seizures, delirium tremens, and respiratory care escalation. Citation: Annals of Pharmacotherapy PubDate: 2024-01-23T11:46:28Z DOI: 10.1177/10600280231222294
- Phenobarbital Versus Benzodiazepines for the Treatment of Severe Alcohol
Withdrawal-
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Authors: Katherine M. Kessel, Logan M. Olson, Derek A. Kruse, Elizabeth R. Lyden, Kelsey E. Whiston, Mindy M. Blodgett, Alena A. Balasanova Abstract: Annals of Pharmacotherapy, Ahead of Print. Background:Phenobarbital may offer advantages over benzodiazepines for severe alcohol withdrawal syndrome (SAWS), but its impact on clinical outcomes has not been fully elucidated.Objective:The purpose of this study was to determine the clinical impact of phenobarbital versus benzodiazepines for SAWS.Methods:This retrospective cohort study compared phenobarbital to benzodiazepines for the management of SAWS for patients admitted to progressive or intensive care units (ICUs) between July 2018 and July 2022. Patients included had a history of delirium tremens (DT) or seizures, Clinical Institute Withdrawal Assessment of Alcohol-Revised (CIWA-Ar)>15, or Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score ≥4. The primary outcome was hospital length of stay (LOS). Secondary outcomes included progressive or ICU LOS, incidence of adjunctive pharmacotherapy, and incidence/duration of mechanical ventilation.Results:The final analysis included 126 phenobarbital and 98 benzodiazepine encounters. Patients treated with phenobarbital had shorter median hospital LOS versus those treated with benzodiazepines (2.8 vs 4.7 days; P < 0.0001); a finding corroborated by multivariable analysis. The phenobarbital group also had shorter median progressive/ICU LOS (0.7 vs 1.3 days; P < 0.0001), and lower incidence of dexmedetomidine (P < 0.0001) and antipsychotic initiation (P < 0.0001). Fewer patients in the phenobarbital group compared to the benzodiazepine group received new mechanical ventilation (P = 0.045), but median duration was similar (1.2 vs 1.6 days; P = 1.00).Conclusion and relevance:Scheduled phenobarbital was associated with decreased hospital LOS compared to benzodiazepines for SAWS. This was the first study to compare outcomes of fixed-dose, nonoverlapping phenobarbital to benzodiazepines in patients with clearly defined SAWS and details a readily implementable protocol. Citation: Annals of Pharmacotherapy PubDate: 2024-01-22T05:05:25Z DOI: 10.1177/10600280231221241
- Pirtobrutinib: A New and Distinctive Treatment Option for B-Cell
Malignancies-
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Authors: Madeline D. Schultze, David J. Reeves Abstract: Annals of Pharmacotherapy, Ahead of Print. Objective:The objective was to evaluate the efficacy/safety of pirtobrutinib in the treatment of B-cell malignancies and distinguish it from other available Bruton’s tyrosine kinase (BTK) inhibitors.Data sources:A literature search of PubMed (January 2021 through November 2023) and Clinicaltrials.gov was conducted using terms pirtobrutinib, Jaypirca, and LOXO 305. Licensing trials of available BTK inhibitors were also reviewed.Study selection and data extraction:Relevant English-language clinical trials were evaluated.Data synthesis:Pirtobrutinib was approved by the US Food and Drug Administration for the treatment of relapsed/refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) based largely on a phase 1/2 study in B-cell malignancies. Pirtobrutinib demonstrated a 73% overall response rate (ORR) in the CLL population and 58% in MCL. Pirtobrutinib has activity in patients resistant to earlier-generation, covalent BTK inhibitors. In fact, the ORRs were similar in BTK-pretreated and naïve patients. Adverse effects include fatigue, diarrhea, bleeding, and infection. Atrial fibrillation, a class effect of BTK inhibitors, may be less common with pirtobrutinib.Relevance to patient care and clinical practice in comparison with existing drugs:Compared with earlier-generation BTK inhibitors, pirtobrutinib is more selective for BTK and binds noncovalently to the receptor. Ongoing studies are evaluating pirtobrutinib’s use in multiple B-cell malignancies and comparing it with other BTK inhibitors.Conclusion:The characteristics of pirtobrutinib render it useful in the treatment of B-cell malignancies no longer responding to a previous BTK inhibitor, and results from ongoing clinical trials may support future expanded use. Citation: Annals of Pharmacotherapy PubDate: 2024-01-18T11:34:41Z DOI: 10.1177/10600280231223737
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