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比较极度肥胖患者中直接口服抗凝剂与华法林的安全性和疗效。

Comparing Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin in Extreme Obesity.

机构信息

Pharmacy Services, VA St Louis Health Care System, John Cochran Division, St Louis, MO, USA.

出版信息

J Pharm Pract. 2023 Dec;36(6):1375-1382. doi: 10.1177/08971900221116809. Epub 2022 Aug 8.

Abstract

Limited clinical data exists regarding use of direct oral anticoagulants (DOACs) in extreme obesity, specifically those ≥140 kg or having a body mass index (BMI) ≥ 50 kg/m. Evaluate the safety and efficacy of DOACs in extreme obesity. A retrospective chart review was performed at a single center of patients aged 18-89 years and weight ≥140 kg or BMI ≥50 kg/m receiving warfarin or DOAC therapy. Patients were followed for 1 year from prescribing/study inclusion. The primary outcome was the difference in rates of any bleed (composite of major, nonmajor clinically relevant, or minor bleeding events as defined by International Society of Thrombosis and Haemostasis (ISTH) criteria) between groups. Secondary outcomes included individual components of the composite primary outcome and effectiveness in preventing thrombotic events within 12 months. Post-hoc multivariate analysis evaluated potential predictors of bleeding events within overall patient population. Two-hundred eighty-five patients were included, 80 and 205 in the DOAC and warfarin groups, respectively. Rates of any documented bleeding event were comparable in DOAC and warfarin groups (17.5% vs 17.1%, > .05). No significant difference in rates of minor ( = .067), nonmajor clinically relevant ( = .825), and major ( = 1) bleeding events were observed. Two thrombotic events occurred in the warfarin group compared to none in the DOAC group. Increasing weight was associated with bleeding events in multivariate analysis. This data did not demonstrate a difference in safety or efficacy outcomes between DOACs and warfarin when utilized in patients with extreme obesity.

摘要

关于直接口服抗凝剂(DOACs)在极度肥胖患者中的应用,特别是体重≥140kg 或体重指数(BMI)≥50kg/m²的患者,目前仅有有限的临床数据。评估 DOAC 在极度肥胖患者中的安全性和疗效。在一家中心对 18-89 岁、体重≥140kg 或 BMI≥50kg/m²接受华法林或 DOAC 治疗的患者进行了回顾性图表审查。患者从处方/研究纳入开始随访 1 年。主要结局是两组之间任何出血(国际血栓与止血学会(ISTH)标准定义的主要、非主要临床相关或轻微出血事件的复合)发生率的差异。次要结局包括复合主要结局的各个组成部分和 12 个月内预防血栓事件的有效性。事后多变量分析评估了总体患者人群中出血事件的潜在预测因素。共纳入 285 例患者,DOAC 组和华法林组分别为 80 例和 205 例。DOAC 和华法林组的任何有记录的出血事件发生率相当(17.5% vs 17.1%,>.05)。轻微(=0.067)、非主要临床相关(=0.825)和主要(=1)出血事件发生率无显著差异。华法林组发生 2 例血栓事件,而 DOAC 组无血栓事件。多变量分析显示,体重增加与出血事件相关。当在极度肥胖患者中使用 DOAC 和华法林时,本数据未显示安全性或疗效结局存在差异。

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