Annals of Pharmacotherapy最新文献

{"title":"Time to Target Anti-Xa Level in Obese Vs Nonobese Patients Using an Adjusted Body Weight Heparin Infusion Protocol for the Treatment of Venous Thromboembolism.","authors":"Mary K Eibye, Jacqueline N Poston, Amanda G Kennedy, Michael DeSarno, Rebecca M Nashett","doi":"10.1177/10600280251321478","DOIUrl":"10.1177/10600280251321478","url":null,"abstract":"<p><strong>Background: </strong>Unfractionated heparin (UFH) is a first-line option for the acute treatment of venous thromboembolism (VTE). Weight-based dosing protocols have demonstrated a decreased time to therapeutic anticoagulation, however, there are limited data on their utilization in obese patients, including the type of weight used.</p><p><strong>Objective: </strong>The purpose of this study was to determine equivalency in time to reach target antifactor-Xa (anti-Xa) for obese and nonobese patients using the same adjusted body weight (AdjBW)-based UFH infusion protocol.</p><p><strong>Methods: </strong>This was a single-center retrospective study of patients aged 18 years or older receiving an infusion of UFH for the treatment of VTE. The primary outcome was the median time to first target anti-Xa. Secondary outcomes included the percentage of first anti-Xa levels at 6 hours that were within, below, or above the target range and the median time to the second consecutive anti-Xa level within the target range. The safety outcome of evidence of major bleed was also evaluated.</p><p><strong>Results: </strong>Of the 166 patients assessed (75 obese and 91 nonobese), there was no observed difference in median time to first target anti-Xa in obese vs nonobese patients when using an AdjBW UFH protocol (12.45 vs 13.03 hours, <i>P</i> = 0.49). The percentage of patients achieving a target anti-Xa at first evaluation did not differ between obese and nonobese groups (32.0% vs 34.07%, <i>P</i> = 0.78). A total of 14 patients across groups experienced evidence of major bleed, with no observed difference between obese and nonobese groups (8.00% vs 8.89%, <i>P</i> = 0.84).</p><p><strong>Conclusions and relevance: </strong>There was no observed difference in median time to first target anti-Xa in obese vs nonobese patients when using an AdjBW heparin infusion protocol, with no observed difference in evidence of major bleed. Our findings support the use of AdjBW in weight-based UFH dosing.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1007-1014"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Error Incidence Between Single-Tablet Versus Multiple-Tablet INSTI-Based Regimens in the Inpatient Setting.","authors":"Denise Kelley, Kayla Blackmon, Brian L Nguyen, Dusten T Rose","doi":"10.1177/10600280251324337","DOIUrl":"10.1177/10600280251324337","url":null,"abstract":"<p><strong>Background: </strong>Errors related to antiretroviral therapy (ART) occur in up to 86% of hospitalized patients living with human immunodeficiency virus (HIV) and may contribute to treatment failure, drug resistance, adverse effects, and toxicity. ART can be administered as a single-tablet regimen (STR) or multiple-tablet regimen (MTR), with limited data on whether the number of tablets affects inpatient error incidence.</p><p><strong>Objective: </strong>The purpose of this study was to determine the error rate of substituting dolutegravir-based STRs to an MTR while admitted.</p><p><strong>Methods: </strong>This multicenter, retrospective, observational study in adult inpatients receiving ART for HIV evaluated continuation of bictegravir-based STR versus dolutegravir-based STR given as an MTR. The primary outcome was the composite error incidence when ART was dispensed as an STR versus MTR. Secondary endpoints included number of errors per patient encounter, between-group error types, time to error correction and pharmacist involvement, and conversion back to STR at discharge.</p><p><strong>Results: </strong>Of 514 patient encounters (257 bictegravir-based STR; 257 dolutegravir-based MTR), there was a significantly lower composite incidence of errors in the STR group versus the MTR group (23% vs 31.5%; <i>P</i> = 0.029). A significantly higher incidence of dose-related errors in the MTR group occurred related to renal or hepatic dose adjustments, which was the only significantly different between-group error type identified. Approximately one error per encounter was identified in both groups, with median time to error correction slightly over 1 day. Multiple-tablet regimens were converted back to an STR at discharge in 89.9% of admissions.</p><p><strong>Conclusion and relevance: </strong>Providing INSTI-based ART as an STR while admitted may reduce ART-related medication errors and has potential to improve patient care; however, use of an STR may not address errors related to inappropriate dosing in organ dysfunction. Increased vigilance for medication errors is warranted when substituting with MTRs in inpatient settings.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"999-1006"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between Rocuronium Administration and Clinical Outcomes in Patients With Moderate-To-Severe Acute Respiratory Distress Syndrome: A Retrospective Cohort Study.","authors":"Mayuko Tonai, Yusuke Sasabuchi, Hideaki Watanabe, Hiroki Matsui, Hideo Yasunaga","doi":"10.1177/10600280251329195","DOIUrl":"10.1177/10600280251329195","url":null,"abstract":"<p><strong>Background: </strong>Neuromuscular blocking agents (NMBAs) are commonly used to manage acute respiratory distress syndrome (ARDS). However, the efficacy of continuous NMBA administration other than cisatracurium remains understudied.</p><p><strong>Objective: </strong>To examine the association between continuous rocuronium administration and clinical outcomes in patients with moderate-to-severe ARDS.</p><p><strong>Methods: </strong>A retrospective cohort study was performed using data from a Japanese national inpatient database (April 2018-March 2022). Adult patients with pneumonia requiring mechanical ventilation in the intensive care unit (ICU), with respiratory Sequential Organ Failure Assessment score of ≥3 were included. The patients were divided into those receiving continuous rocuronium (exposure group) and those not receiving any continuous NMBAs (comparison group). The association between continuous rocuronium administration and outcomes was analyzed using multivariable regression analyses fitted with generalized estimating equations.</p><p><strong>Results: </strong>Among 1992 eligible patients, 124 received rocuronium. In-hospital mortality were 30.8% and 25.8% in the comparison and exposure groups, respectively. No significant differences observed in in-hospital mortality (odds ratio [OR] 0.70; 95% confidence interval [CI]: 0.42 to 1.19), ICU mortality (9.0% vs 8.9%, OR 0.87; 95% CI: 0.41 to 1.87), median length of hospital stay (26 vs 28 days, %change 10.5; 95% CI: -8.9 to 34.1), ICU stay (8 vs 10 days, %change 9.0; 95% CI: -4.3 to 24.2), or mechanical ventilation (7 vs 10 days, %change 10.3; 95% CI: -5.3 to 28.5).</p><p><strong>Conclusion and relevance: </strong>Continuous rocuronium administration for moderate-to-severe ARDS, specifically in patients with pneumonia, was not associated with either improved or worsened clinical outcomes. These findings suggest that rocuronium may be a feasible option as a supportive therapy for ventilator management in patients with moderate-to-severe ARDS, providing a basis for further research in clinical settings.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"969-977"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143741846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Olezarsen for the Treatment of Familial Chylomicronemia Syndrome.","authors":"Bradley Phillips, Cierra Abbott, Savanna Breit, Erin St Onge","doi":"10.1177/10600280251332500","DOIUrl":"10.1177/10600280251332500","url":null,"abstract":"<p><strong>Objective: </strong>This review aims to evaluate the efficacy and safety of olezarsen (Tryngolza) in treating familial chylomicronemia syndrome (FCS), a rare genetic disorder characterized by severe hypertriglyceridemia.</p><p><strong>Data sources: </strong>A comprehensive literature search was conducted via PubMed from January 2022 to mid-March 2025, using keywords such as olezarsen, antisense oligonucleotide, triglyceride, hypertriglyceridemia, apolipoprotein C3 (APOC3), and cardiovascular.</p><p><strong>Study selection and data extraction: </strong>Relevant English-language studies assessing the pharmacokinetics, pharmacology, efficacy, or safety of olezarsen were included. Data from the US Food and Drug Administration (FDA)-approved package insert were also reviewed.</p><p><strong>Data synthesis: </strong>Olezarsen is an antisense oligonucleotide targeting APOC3 mRNA, a key regulator of plasma triglyceride levels. It has been shown to significantly reduce triglyceride levels via APOC3 protein degradation. Clinical trials have demonstrated substantial reductions in triglyceride levels and APOC3, with minimal adverse events. Phase 2 and 3 trials showed consistent efficacy and safety profiles, with common adverse events including COVID-19 infection, abdominal pain, and diarrhea.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Olezarsen offers a targeted and effective treatment for FCS, addressing limitations of traditional therapies such as fibrates, omega-3 fatty acids, and statins. Its novel mechanism of action and once-monthly dosing regimen may improve patient adherence, providing significant advancement in FCS management.</p><p><strong>Conclusion and relevance: </strong>Olezarsen represents a new treatment for FCS, offering a targeted approach to significantly reduce triglyceride levels. Its integration into clinical practice has the potential to transform the management of FCS; however, more studies are needed to firmly establish its role.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1031-1036"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143954236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Overview of Challenges With Using Cost-Effectiveness Analysis for Evaluating Medications.","authors":"Christopher J Edwards, Brian L Erstad","doi":"10.1177/10600280251327434","DOIUrl":"10.1177/10600280251327434","url":null,"abstract":"<p><p>Countries such as Australia with universal healthcare perform cost-effectiveness evaluations of new prescription medications. In the United States, there is no assessment of cost-effectiveness analysis at the national level with the notable exception of the Advisory Committee on Immunization Practices that evaluates vaccines. The purpose of this paper is to provide an overview of the challenges of using cost-effectiveness for evaluating medications with an emphasis on the United States health care system. Cost-effectiveness analysis involves the value of a health outcome expressed in terms of cost relative to natural units or relative to utility measurements such as quality-adjusted life-years. Besides the assumptions underlying all cost-effectiveness analysis, there are challenges in appropriately assessing the cost and utility parameters. A major concern limiting the use of cost-utility analysis is that people with worse health due to age, disability, or co-morbidities always have lower utility values than an otherwise healthy patient with the same disease since the utility variable is calculated by the product of life-years and health utility weight. This had led to calls for revisions of cost-utility analyses, but characterizing the utility value is only one of several challenges with performing economic evaluations of medications in the absence of a single-payer system in the United States. Multiple criteria decision analysis is currently being used by the Food and Drug Administration (FDA) to provide information beyond modifications to the cost-effectiveness metric by taking into account multiple criteria and perspectives but controlling drug costs requires system-wide changes.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1037-1042"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143952596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Holiday Season Incretin Therapy for Long-Term Weight Maintenance.","authors":"Nicholas W Carris, Shawn Wallace, Marilyn Stern, Brian Bunnell","doi":"10.1177/10600280251330903","DOIUrl":"10.1177/10600280251330903","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1046-1047"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gabapentinoïds and Hip Fracture: A Pharmacovigilance Comparative Study Between Gabapentin and Pregabalin.","authors":"Jean-Louis Montastruc","doi":"10.1177/10600280251336244","DOIUrl":"10.1177/10600280251336244","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1043-1045"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143961275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Albumin-Bilirubin-Fibrosis-4 Score for Predicting Teicoplanin-Induced Abnormal Liver Enzyme Levels in Patients Undergoing Therapeutic Drug Monitoring: A Multicentral Retrospective Cohort Study.","authors":"Hayahide Ooi, Yuki Asai, Yoshihiro Kondo, Takumi Tashiro, Nobuyuki Zakoji, Maria Aoki, Yoshiki Koriyama, Takuya Iwamoto, Masaaki Takahashi","doi":"10.1177/10600280251319519","DOIUrl":"10.1177/10600280251319519","url":null,"abstract":"<p><strong>Background: </strong>Although therapeutic drug monitoring (TDM) maintains serum teicoplanin (TEIC) concentration between 15 and 30 μg/mL, TEIC-induced liver injury may still occur. The albumin-bilirubin (ALBI)-fibrosis-4 (FIB-4) score may be useful for predicting TEIC-induced liver injury in patients undergoing TDM.</p><p><strong>Objective: </strong>This pilot study aimed to investigate whether the ALBI-FIB4 score can predict TEIC-induced abnormal liver enzyme levels in patients undergoing TDM.</p><p><strong>Methods: </strong>The multicenter retrospective cohort study included 140 patients undergoing TDM of TEIC at steady state. The primary outcome was TEIC-induced abnormal liver enzyme levels. Cut-off values for the alanine aminotransferase (ALT), ALBI score, FIB-4 index, and ALBI-FIB4 score were detected using receiver-operating characteristic curves. The cumulative risk of TEIC-induced abnormal liver enzyme levels was evaluated using Kaplan-Meier curves analyzed log-rank test. Subgroup analysis was performed to examine cumulative risk in patients with serum TEIC concentration of <30 μg/mL.</p><p><strong>Results: </strong>The incidence of TEIC-induced abnormal liver enzyme levels was 14.3% (20/140). Cut-off values were 24 IU/L for ALT (sensitivity: 0.800; specificity: 0.692; area under the curve [AUC]: 0.753), -1.33 for the ALBI score (sensitivity: 0.550; specificity: 0.617; AUC: 0.539), 2.73 for the FIB-4 index (sensitivity: 0.700; specificity: 0.475; AUC: 0.550), and -0.85 for the ALBI-FIB4 score (sensitivity: 0.800; specificity: 0.467; AUC: 0.572). The cumulative risk of TEIC-induced abnormal liver enzyme levels was significantly higher for patients with ALT ≥24 IU/L (<i>P</i> < 0.01) and ALBI-FIB4 score ≥-0.85 (<i>P</i> = 0.042). Patients with a serum TEIC concentration of <30 µg/mL exhibited a similar trend, with a higher cumulative risk for patients with ALBI-FIB4 score ≥-0.85 (<i>P</i> = 0.058).</p><p><strong>Conclusion and relevance: </strong>An ALBI-FIB4 score ≥-0.85 may serve as a potential predictor for TEIC-induced abnormal liver enzyme levels in patients undergoing TDM. However, evidence supporting this threshold requires further statistical validation using a larger dataset.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"978-988"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dupilumab Use in Eosinophilic Esophagitis: Analysis of the FDA Adverse Event Reporting System Database.","authors":"Michael B Andrews, Hiba Khan, Douglas G Adler","doi":"10.1177/10600280251336243","DOIUrl":"10.1177/10600280251336243","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1048-1050"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143956576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serotonergic Antidepressant Use and Risk of Clinically Significant Bleeding in Thrombocytopenic Hematologic Malignancy Patients.","authors":"Hannah Delp, Marissa Olson, Emily Owen, Colleen McEvoy, Emily Gill","doi":"10.1177/10600280251319757","DOIUrl":"10.1177/10600280251319757","url":null,"abstract":"<p><strong>Background: </strong>Serotonin reuptake inhibitor (SRI) antidepressants have known antiplatelet properties. Patients with hematologic malignancies (HMs) are at an increased risk of bleeding complications due to their malignancy and treatment-induced thrombocytopenia.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate the risk of clinically significant bleeding (CSB) in patients with HM and thrombocytopenia who are prescribed SRIs.</p><p><strong>Methods: </strong>This retrospective cohort study included adult patients admitted to the hospital with HM and thrombocytopenia. Patients were stratified into SRI-exposed and SRI-unexposed groups. Patients were followed up until resolution of thrombocytopenia, hospital discharge, death, or SRI therapy interruption. The primary outcome was the incidence of CSB.</p><p><strong>Results: </strong>A total of the 324 patients were included in the study (119 SRI exposed vs 205 SRI unexposed). The median baseline platelet value was 35 × 10⁹/L and 31 × 10⁹/L, respectively. The median platelet nadir was 6 × 10⁹/L, and the median duration of study inclusion was 12 days in both groups. No difference was seen in the incidence of CSB between groups (16% vs 13%, <i>P</i> = 0.487). Hospital length of stay (LOS) (20 vs 19 days, <i>P</i> = 0.227) and intensive care unit (ICU) LOS (3.9 vs 3.9 days, <i>P</i> = 0.996) were similar between groups. On multivariable analysis, SRI exposure was not independently associated with CSB (adjusted odds ratio [aOR] = 1.46, 95% confidence interval [CI] 0.75-2.86).</p><p><strong>Conclusion and relevance: </strong>In patients with HM and thrombocytopenia, SRI exposure was not associated with an increased risk of CSB. Given the small study size, assessment of patient-specific risks versus benefits should still be considered when prescribing SRI therapy in this patient population.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"989-998"},"PeriodicalIF":2.3,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}