Efficacy and Safety of Dabigatran vs. Warfarin in Patients With Atrial Fibrillation - Sub-Analysis in Japanese Population in RE-LY Trial
Efficacy and Safety of Dabigatran vs. Warfarin in Patients With Atrial Fibrillation - Sub-Analysis in Japanese Population in RE-LY Trial
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DOI：
10.1253/circj.cj-11-0191
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发表时间：
2011-04-01
影响因子：
3.3
通讯作者：
Wallentin, Lars
中科院分区：
文献类型：
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作者：
Hori, Masatsugu;Connolly, Stuart J.;Wallentin, Lars
背景：Re-LY(长期抗凝治疗的随机评估)是一项国际多中心研究(来自44个国家和地区的967个中心的18,113名患者)，证明了与接受华法林治疗的患者相比，达比加特兰能够减少中风风险较高的房颤患者的中风和出血的发生。来自日本的326名患者随机接受RE-LY治疗。方法和结果：Re-LY设计用于比较两种固定剂量(110 mg或150 mg，每天两次)的Dabigatran，每个剂量都是以盲法给药，与开放标签的华法林使用进行比较。在总体研究人群和日本患者中，患者人口统计信息没有重大差异。然而。在日本患者中，有中风病史的比例较高，但有心肌梗死病史的比例低于总体水平。Dabigatran 110 mg/d，150 mg/d和华法林分别为1.38、0.67和2.65%/年。这些结果与总体结果相似(每组分别为1.54、1.11和1.71%/年)。对于任何出血，达比加兰每天两次110 mg和150 mg与华法林相比的相对危险度分别为0.79和1.06，与总体结果相似(达比卡兰110 mg每天两次：0.78；150 mg每天两次：0.91)。结论：在RE-LY中，达比加兰对卒中高危日本房颤患者的疗效和安全性基本上与研究人群的总体相同。(保监会J 2011；75：800-805)
Background: RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) is an international multi-center study (18,113 patients from 967 centers in 44 countries) that demonstrated the ability of dabigatran to reduce the occurrence of both stroke and hemorrhage in patients who had atrial fibrillation (AF) with high risks of stroke compared with patients who received warfarin. From Japan, 326 patients were randomized in RE-LY.Methods and Results: RE-LY was designed to compare 2 fixed doses (110 mg or 150 mg, twice daily) of dabigatran, each administered in a blinded manner, with open-label use of warfarin. There were no major differences in patient demographic information among the overall study population and Japanese patients. However. in Japanese patients, the proportion of prior stroke was higher but prior myocardial infarction was lower than in the overall. The yearly rate for the primary endpoints (stroke and systemic embolism) was 1.38, 0.67 and 2.65%/year for 110 mg and 150 mg dabigatran twice daily and warfarin, respectively. These results were similar to the overall results (1.54, 1.11 and 1.71%/year for each group, respectively). For any bleeding, the relative risk of dabigatran at 110 mg and 150 mg twice daily over warfarin was 0.79 and 1.06, respectively, which was similar to the findings overall (dabigatran 110 mg twice daily: 0.78; 150 mg twice daily: 0.91).Conclusions: In RE-LY, the efficacy and safety profiles of dabigatran for Japanese AF patients at high risk of stroke were essentially the same as for the study population overall. (Circ J 2011; 75: 800-805)