Chen Junyu, Zhuang Xiaodong, Long Ming, Su Chen, Wang Lichun
Department of Cardiology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong 510080, China.
Department of Cardiology, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong 510080, China.
J Stroke Cerebrovasc Dis. 2015 Dec;24(12):2710-9. doi: 10.1016/j.jstrokecerebrovasdis.2015.07.026. Epub 2015 Aug 29.
Edoxaban is a potential alternative to warfarin for preventing thromboembolism in atrial fibrillation. However, the efficacy and safety, and the optimal regimen of edoxaban are still controversial. This study compared the efficacy and safety of edoxaban and warfarin in nonvalvular atrial fibrillation, and the effects of different edoxaban dosages.
A systematic search for randomized controlled trials comparing edoxaban with warfarin in nonvalvular atrial fibrillation was conducted using PubMed, EMBASE, and the Cochrane Library databases. The main measures and outcomes included efficacy end points (thromboembolic events and all-cause mortality) and safety end points (all bleeding events, major bleeding events, clinically relevant nonmajor bleeding, and minor bleeding).
Four studies including 23,001 patients were included in the meta-analysis. Edoxaban was noninferior to warfarin for preventing stroke and systemic embolism (risk ratio [RR] = 1.00; 95% confidence interval [CI], .88-1.13; Z = .01; P = .99). In safety analyses, edoxaban was superior to warfarin in terms of major bleeding, clinically relevant nonmajor bleeding, and minor bleeding (all P <.00001). In terms of optimal dosing, 30 mg/day edoxaban had a significantly lower risk of all bleeding (RR = .79; 95% CI, .75-.83; Z = 9.07; P <.00001) than 60 mg/day, but was inferior at preventing stroke and systemic embolism (RR = 1.31; 95% CI, 1.13-1.51; Z = 3.56; P = .0004).
Edoxaban was noninferior to warfarin in terms of efficacy and superior to warfarin in terms of safety. The benefits of edoxaban were related to the dose; efficacy was better at 60 mg/day, but there was lower risk of bleeding at 30 mg/day.
依度沙班是华法林在预防心房颤动血栓栓塞方面的一种潜在替代药物。然而，依度沙班的疗效和安全性以及最佳用药方案仍存在争议。本研究比较了依度沙班和华法林在非瓣膜性心房颤动中的疗效和安全性，以及不同依度沙班剂量的影响。
使用PubMed、EMBASE和Cochrane图书馆数据库系统检索比较依度沙班与华法林治疗非瓣膜性心房颤动的随机对照试验。主要测量指标和结果包括疗效终点（血栓栓塞事件和全因死亡率）和安全性终点（所有出血事件、大出血事件、临床相关非大出血和小出血）。
四项研究共纳入23001例患者进行荟萃分析。在预防中风和全身性栓塞方面，依度沙班不劣于华法林（风险比[RR]=1.00；95%置信区间[CI]，0.88-1.13；Z=0.01；P=0.99）。在安全性分析中，依度沙班在大出血、临床相关非大出血和小出血方面优于华法林（所有P<0.00001）。在最佳剂量方面，与60毫克/天相比，30毫克/天依度沙班的所有出血风险显著更低（RR=0.79；95%CI，0.75-0.83；Z=9.07；P<0.00001），但在预防中风和全身性栓塞方面较差（RR=1.31；95%CI，1.13-1.51；Z=3.56；P=0.0004）。
依度沙班在疗效方面不劣于华法林，在安全性方面优于华法林。依度沙班的益处与剂量有关；60毫克/天的疗效更好，但30毫克/天的出血风险更低。
