Edoxaban is a once-daily oral anticoagulant that rapidly and selectively inhibits factor Xa in a concentration-dependent manner. This review describes the extensive clinical development program of edoxaban, including phase III studies in patients with non-valvular atrial fibrillation (NVAF) and symptomatic venous thromboembolism (VTE). The ENGAGE AF-TIMI 48 study (N = 21,105; mean CHADS2 score 2.8) compared edoxaban 60 mg once daily (high-dose regimen) and edoxaban 30 mg once daily (low-dose regimen) with dose-adjusted warfarin [international normalized ratio (INR) 2.0-3.0] and found that both regimens were non-inferior to warfarin in the prevention of stroke and systemic embolism in patients with NVAF. Both edoxaban regimens also provided significant reductions in the risk of hemorrhagic stroke, cardiovascular mortality, major bleeding and intracranial bleeding. The Hokusai-VTE study (N = 8,292) in patients with symptomatic VTE had a flexible treatment duration of 3-12 months and found that following initial heparin, edoxaban 60 mg once daily was non-inferior to dose-adjusted warfarin (INR 2.0-3.0) for the prevention of recurrent VTE, and also had a significantly lower risk of bleeding events. Both studies randomized patients at moderate-to-high risk of thromboembolic events and were further designed to simulate routine clinical practice as much as possible, with edoxaban dose reduction (halving dose) at randomisation or during the study if required, a frequently monitored and well-controlled warfarin group, a well-monitored transition period at study end and a flexible treatment duration in Hokusai-VTE. Given the phase III results obtained, once-daily edoxaban may soon be a key addition to the range of antithrombotic treatment options.

译文

:Edoxaban是每日一次的口服抗凝剂,以浓度依赖的方式快速选择性地抑制Xa因子。这篇综述描述了edoxaban的广泛临床开发计划,包括针对非瓣膜性房颤(NVAF)和有症状的静脉血栓栓塞(VTE)的患者的III期研究。 ENGAGE AF-TIMI 48研究(N = 21,105;平均CHADS2评分2.8)将依多沙班60 mg每天一次(大剂量方案)和依多沙班30 mg每天一次(低剂量方案)与剂量调整的华法林比较[国际标准化比例(INR)2.0-3.0],发现这两种方案在NVAF患者预防中风和全身性栓塞方面均不逊于华法林。两种edoxaban方案还大大降低了出血性中风,心血管疾病死亡率,大出血和颅内出血的风险。 Hokusai-VTE研究(N = 8,292)对有症状VTE的患者进行了3到12个月的灵活治疗,发现最初的肝素治疗后,每天一次60 mg edoxaban不逊于剂量调整后的华法林(INR 2.0- 3.0)可预防复发性VTE,并且出血事件的风险也显着降低。两项研究均将血栓栓塞事件的中至高风险患者随机分组,并进一步设计为尽可能模拟常规临床实践,随机或在研究期间使用依多沙班减量剂量(减半剂量),经常监测并良好控制的华法林组,在研究结束时监测良好的过渡期,在北斋VTE中采用灵活的治疗时间。鉴于已获得III期结果,每天一次的edoxaban可能很快成为抗血栓治疗方案范围的关键补充。

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