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利伐沙班与华法林在极度肥胖和高体重人群中的卒中预防和静脉血栓栓塞症治疗中的比较。

Rivaroxaban Versus Warfarin for Stroke Prevention and Venous Thromboembolism Treatment in Extreme Obesity and High Body Weight.

机构信息

University of Arizona, Tucson, AZ, USA.

Banner-University Medical Center Tucson, Tucson AZ, USA.

出版信息

Ann Pharmacother. 2020 Apr;54(4):344-350. doi: 10.1177/1060028019886092. Epub 2019 Oct 31.

Abstract

Limited clinical data exist describing the use of direct-acting oral anticoagulants (DOACs) in patients with body mass index (BMI) >40 kg/m or body weight >120 kg. Thus, DOAC therapy in this population remains controversial. To investigate rivaroxaban as a safe and effective alternative to warfarin for venous thromboembolism (VTE) treatment and prevention of stroke in patients with atrial fibrillation identified as extremely obese or of high body weight. A retrospective chart review was performed at 2 academic medical centers in patients ≥18 years old and BMI >40 kg/m or weight >120 kg, newly initiated on warfarin or rivaroxaban for atrial fibrillation or VTE treatment. The primary end point was incidence of clinical failure, defined as VTE recurrence, stroke incidence, and mortality, within 12 months of initiation. Secondary end points included length of stay (LOS) and bleeding complications. A total of 176 patients were included, with 84 and 92 patients in the rivaroxaban and warfarin arms, respectively. Clinical failure was lower in the rivaroxaban group but did not reach statistical significance when compared with warfarin (5% vs 13%; = 0.06). LOS was significantly shorter in the rivaroxaban arm (2 days [1-3] vs 4 days [2-7], < 0.0001). Percentage of bleeding complications was higher in the rivaroxaban arm but not statistically significant (8% vs 2%, = 0.06). Although not statistically significant, rivaroxaban trended toward a lower incidence of clinical failure while demonstrating a significantly shorter LOS when compared with warfarin for VTE treatment or atrial fibrillation in morbidly obese or high-body-weight patients.

摘要

目前仅有少量临床数据描述了直接口服抗凝剂(DOAC)在体重指数(BMI)>40kg/m²或体重>120kg 的患者中的应用。因此,该人群中 DOAC 治疗仍存在争议。本研究旨在评估利伐沙班作为华法林在病态肥胖或高体重房颤患者中治疗静脉血栓栓塞症(VTE)和预防卒中的安全有效替代药物。

我们对 2 家学术医疗中心≥18 岁、BMI>40kg/m²或体重>120kg、新诊断为房颤或 VTE 的患者进行了回顾性图表审查,评估其应用华法林或利伐沙班的情况。主要终点为治疗开始后 12 个月内的临床失败发生率,定义为 VTE 复发、卒中和死亡率。次要终点包括住院时间(LOS)和出血并发症。共纳入 176 例患者,利伐沙班组和华法林组分别为 84 例和 92 例。利伐沙班组临床失败发生率较低,但与华法林相比无统计学差异(5%比 13%;=0.06)。利伐沙班组 LOS 明显缩短(2 天[1-3]比 4 天[2-7],<0.0001)。利伐沙班组出血并发症发生率较高,但无统计学差异(8%比 2%,=0.06)。

虽然无统计学差异,但与华法林相比,利伐沙班治疗病态肥胖或高体重患者的 VTE 或房颤时,临床失败发生率有降低趋势,同时 LOS 明显缩短。

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