May Hilu, Mariana Issawy, Raul Colodner, Harel Eitam, Gilat Ron Avraham, Kerstin Carlin Ram, Mazen Elias, Orli Shimoni, Eyal Schwartzberg, Lee Hilary Goldstein
{"title":"The Influence of High Body Mass Index (BMI > 35 kg/m<sup>2</sup>) on Apixaban Plasma Concentration in Patients with Atrial Fibrillation.","authors":"May Hilu, Mariana Issawy, Raul Colodner, Harel Eitam, Gilat Ron Avraham, Kerstin Carlin Ram, Mazen Elias, Orli Shimoni, Eyal Schwartzberg, Lee Hilary Goldstein","doi":"10.1007/s40256-024-00678-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Apixaban, a direct oral anticoagulant is administered for stroke prevention in atrial fibrillation patients. Dosing adjustment is guided by renal function, age, and body weight. However, no data exist on its pharmacokinetics in patients with a body mass index (BMI) ≥ 35 kg/m<sup>2</sup>. The aim was to investigate the effects of BMI ≥ 35 kg/m<sup>2</sup> on trough plasma concentrations of apixaban in patients with atrial fibrillation.</p><p><strong>Methods: </strong>This prospective study compared steady-state trough concentrations of apixaban in patients with a BMI ≥ 35 kg/m<sup>2</sup> and patients with a BMI < 35 kg/m<sup>2</sup>.</p><p><strong>Results: </strong>Sixty patients were included. In patients receiving 5 mg apixaban twice daily, the median trough plasma concentration was 29% lower in patients with a BMI ≥ 35 kg/m<sup>2</sup> than in those with a BMI < 35 kg/m<sup>2</sup> (148.9 ng/ml, interquartile range [IQR] 94.5-205.6, compared to 209.1 ng/ml, IQR 167-266.8 ng/ml, respectively; P = 0.044). However, median trough concentrations fell within the manufacturer's predicted range for effective steady-state apixaban exposure. A similar trend was observed with 2.5 mg apixaban twice daily, although statistical significance was not reached. Multivariate analysis revealed no correlation between BMI values and trough concentrations.</p><p><strong>Conclusion: </strong>BMI ≥ 35 kg/m<sup>2</sup> patients exhibited lower apixaban trough concentrations, while remaining within the manufacturer's established range for effective steady-state apixaban, suggesting that dose adjustment is unnecessary for this specific patient group.</p>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":" ","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Cardiovascular Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40256-024-00678-w","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: Apixaban, a direct oral anticoagulant is administered for stroke prevention in atrial fibrillation patients. Dosing adjustment is guided by renal function, age, and body weight. However, no data exist on its pharmacokinetics in patients with a body mass index (BMI) ≥ 35 kg/m2. The aim was to investigate the effects of BMI ≥ 35 kg/m2 on trough plasma concentrations of apixaban in patients with atrial fibrillation.
Methods: This prospective study compared steady-state trough concentrations of apixaban in patients with a BMI ≥ 35 kg/m2 and patients with a BMI < 35 kg/m2.
Results: Sixty patients were included. In patients receiving 5 mg apixaban twice daily, the median trough plasma concentration was 29% lower in patients with a BMI ≥ 35 kg/m2 than in those with a BMI < 35 kg/m2 (148.9 ng/ml, interquartile range [IQR] 94.5-205.6, compared to 209.1 ng/ml, IQR 167-266.8 ng/ml, respectively; P = 0.044). However, median trough concentrations fell within the manufacturer's predicted range for effective steady-state apixaban exposure. A similar trend was observed with 2.5 mg apixaban twice daily, although statistical significance was not reached. Multivariate analysis revealed no correlation between BMI values and trough concentrations.
Conclusion: BMI ≥ 35 kg/m2 patients exhibited lower apixaban trough concentrations, while remaining within the manufacturer's established range for effective steady-state apixaban, suggesting that dose adjustment is unnecessary for this specific patient group.
期刊介绍:
Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents.
Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations.
The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.