Clinical Pharmacy Services, Pharmacy Department, Kaiser Permanente Georgia, Atlanta, GA, USA.
Clinical Pharmacy Services, Pharmacy Department, Virginia Garcia Memorial Health Center, Hillsboro, OR, USA.
Thromb Res. 2021 Dec;208:176-180. doi: 10.1016/j.thromres.2021.11.007. Epub 2021 Nov 17.
Patients with obesity were underrepresented in studies evaluating the safety and effectiveness of direct oral anticoagulants (DOAC) in patients with non-valvular atrial fibrillation (NVAF). This study compared clinical outcomes in patients with NVAF and weighing >120 kg and ≤120 kg who were receiving dabigatran.
This retrospective, matched, longitudinal cohort study included patients from three integrated healthcare delivery systems. Patients ≥18 years of age with NVAF were included if between September 1, 2016 and June 30, 2019 they received dabigatran. Patients >120 kg and ≤120 kg were matched up to 1:6 on age, sex, and CHADS-VASc score. Data were extracted from administrative databases. The primary outcome was a composite of ischemic stroke, clinically-relevant bleeding, systemic embolism, and all-cause mortality. Multivariable regression analyses were performed.
777 and 3522 patients >120 kg and ≤120 kg, respectively, were matched. The >120 kg group tended to be younger with a higher burden of chronic disease. There was no difference between groups in the composite outcome (adjusted hazard ratio [AHR] 1.10, 95% confidence interval 0.89-1.37) or individual components of the composite. A subanalysis of clinically-relevant bleeding identified that patients >120 kg were at a greater risk of gastrointestinal bleeding (AHR 1.44, 95% CI 1.01-2.05).
In patients with NVAF and >120 kg, dabigatran use was associated with a small increased risk of gastrointestinal bleeding but no differences in stroke, mortality or clinically-relevant bleeding. These findings suggest that dabigatran use is reasonable in patients with NVAF and weight >120 kg.
在评估非瓣膜性心房颤动（NVAF）患者使用直接口服抗凝剂（DOAC）的安全性和有效性的研究中，肥胖患者代表性不足。本研究比较了体重>120kg 和≤120kg 的 NVAF 患者接受达比加群的临床结局。
这是一项回顾性、匹配、纵向队列研究，纳入了三个综合医疗服务系统的患者。纳入标准为：2016 年 9 月 1 日至 2019 年 6 月 30 日期间，年龄≥18 岁，接受达比加群治疗的 NVAF 患者。体重>120kg 和≤120kg 的患者按年龄、性别和 CHADS-VASc 评分进行 1:6 匹配。数据从管理数据库中提取。主要结局为缺血性卒中、临床相关出血、全身性栓塞和全因死亡率的复合结局。进行了多变量回归分析。
分别纳入了 777 名和 3522 名体重>120kg 和≤120kg 的患者。>120kg 组患者年龄较小，慢性疾病负担较高。两组在复合结局（调整后危险比 [AHR] 1.10，95%置信区间 0.89-1.37）或复合结局的各个组成部分方面无差异。对临床相关出血的亚分析表明，体重>120kg 的患者胃肠道出血风险更高（AHR 1.44，95%可信区间 1.01-2.05）。
在 NVAF 且体重>120kg 的患者中，达比加群的使用与胃肠道出血风险略有增加相关，但与卒中、死亡率或临床相关出血无差异。这些发现表明，达比加群在 NVAF 且体重>120kg 的患者中使用是合理的。
