一项多中心回顾性研究，评估阿哌沙班与华法林治疗重度肥胖患者静脉血栓栓塞的疗效和安全性。
Multi-center retrospective study evaluating the efficacy and safety of apixaban versus warfarin for treatment of venous thromboembolism in patients with severe obesity.
作者信息
Crouch Ashley, Ng Tsz Hin, Kelley Denise, Knight Tamara, Edwin Stephanie, Giuliano Christopher
机构信息
Department of Pharmacy, Ascension Seton, Austin, Texas, USA.
Department of Pharmacy, Ascension St. John Hospital, Detroit, Michigan, USA.
出版信息
Pharmacotherapy. 2022 Feb;42(2):119-133. doi: 10.1002/phar.2655. Epub 2021 Dec 23.
STUDY OBJECTIVE
Direct oral anticoagulants are the standard of care for venous thromboembolism (VTE) treatment. These agents are recommended regardless of patient weight and body mass index (BMI). However, there remains limited evidence supporting the use of apixaban in patients with severe obesity with a BMI ≥40 kg/m or weight ≥120 kg. The purpose of this study was to evaluate the efficacy and safety of apixaban for VTE in patients with a BMI ≥40 kg/m or weight ≥120 kg.
DESIGN
This multi-center, retrospective study compared the use of apixaban versus warfarin in patients with severe obesity for the treatment of VTE between January 1, 2012, and December 31, 2019. Patients were identified by diagnosis codes for acute VTE and a weight ≥120 kg or BMI ≥40 kg/m . The primary efficacy outcome was time to recurrence of VTE within 12 months, and the primary safety outcome was time to major bleeding within 12 months. Secondary outcomes included incidence of recurrent VTE, major bleeding, clinically relevant non-major bleeding (CRNMB), all-cause mortality, number of total hospital encounters, and switch in anticoagulant.
MAIN RESULTS
A total of 1099 patients were included in the study. Of these, 314 patients received apixaban and 785 received warfarin. The mean weight and BMI were 137 kg and 46 kg/m , respectively. Time to recurrent VTE was significantly longer in those treated with apixaban compared to warfarin (p = 0.018). After controlling for confounding factors, apixaban use was associated with a reduced risk of recurrent VTE compared to warfarin (hazard ratio [HR] = 0.54, 95% confidence interval [CI]: 0.29-0.97, p = 0.04). There were no significant differences in major bleeding, CRNMB, or all-cause mortality between groups.
CONCLUSION
In patients with a BMI ≥40 kg/m or weight ≥120 kg, apixaban appears to be effective and safe for the treatment of VTE.
研究目的
直接口服抗凝剂是静脉血栓栓塞症（VTE）治疗的标准护理方法。无论患者体重和体重指数（BMI）如何，均推荐使用这些药物。然而，支持在BMI≥40kg/m²或体重≥120kg的严重肥胖患者中使用阿哌沙班的证据仍然有限。本研究的目的是评估阿哌沙班在BMI≥40kg/m²或体重≥120kg的患者中治疗VTE的有效性和安全性。
设计
这项多中心回顾性研究比较了2012年1月1日至2019年12月31日期间阿哌沙班与华法林在严重肥胖患者中治疗VTE的使用情况。通过急性VTE诊断代码以及体重≥120kg或BMI≥40kg/m²来确定患者。主要疗效结局是12个月内VTE复发时间，主要安全结局是12个月内大出血时间。次要结局包括VTE复发率、大出血、临床相关非大出血（CRNMB）、全因死亡率、总住院次数以及抗凝剂转换情况。
主要结果
共有1099例患者纳入研究。其中，314例患者接受阿哌沙班治疗，785例患者接受华法林治疗。平均体重和BMI分别为137kg和46kg/m²。与华法林相比，接受阿哌沙班治疗的患者VTE复发时间显著更长（p = 0.018）。在控制混杂因素后，与华法林相比，使用阿哌沙班与VTE复发风险降低相关（风险比[HR]=0.54，95%置信区间[CI]：0.29 - 0.97，p = 0.04）。两组之间在大出血、CRNMB或全因死亡率方面无显著差异。
结论
在BMI≥40kg/m²或体重≥120kg的患者中，阿哌沙班似乎对治疗VTE有效且安全。
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