Rivaroxaban (Xarelto(®)), a direct factor Xa inhibitor, is approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in Canada or those with nonvalvular AF (NVAF) in the EU, US and Japan. It is administered at a fixed oral dose and generally does not require routine monitoring of coagulation parameters. In the ROCKET AF trial in patients with NVAF and a moderate to high risk of stroke, oral rivaroxaban 20 mg once daily (15 mg once daily in patients with moderate renal impairment) was noninferior to oral dose-adjusted warfarin once daily in preventing primary endpoint events (i.e. stroke and systemic embolism) in the per-protocol population (primary noninferiority analysis) and superior in the on-treatment safety population (primary superiority analysis). Several ROCKET AF subgroup analyses indicated that the treatment effect of rivaroxaban was consistent across patient subgroups stratified according to baseline factors, including the presence or absence of previous stroke or transient ischaemic attack. Patients with moderate renal impairment receiving the reduced rivaroxaban dosage (15 mg once daily) showed a treatment effect consistent with that seen with rivaroxaban 20 mg once daily in patients with normal renal function. The tolerability profile of rivaroxaban was generally acceptable in ROCKET AF, with no significant difference between rivaroxaban and warfarin in the incidence of major or nonmajor clinically-relevant bleeding events (primary safety endpoint). In the Japanese ROCKET AF trial, rivaroxaban 15 mg once daily (10 mg once daily in patients with moderate renal impairment) was noninferior to oral dose-adjusted warfarin once daily in the incidence of major or nonmajor clinically-relevant bleeding (primary study outcome). Thus, rivaroxaban is a reasonable alternative to warfarin for the prevention of stroke and systemic embolism in patients with NVAF.

译文

:Rivaroxaban(Xarelto(®))是Xa的直接抑制剂,已被批准用于预防加拿大的房颤(AF)或欧盟,美国和日本的非瓣膜性AF(NVAF)患者的中风和全身性栓塞。它以固定的口服剂量给药,通常不需要常规监测凝血参数。在ROCKET AF试验中,对于具有NVAF和中度至高中风风险的患者,口服利伐沙班每天20 mg一次(对于中度肾功能不全的患者每天15 mg一次)在预防主要终点方面不逊于口服剂量调整的华法林符合协议的人群发生的事件(即中风和全身性栓塞)(主要为非劣效性分析)和接受治疗的安全性人群中的主要事件(即主要优势分析)。若干ROCKET AF亚组分析表明,利伐沙班的治疗效果在根据基线因素(包括是否存在先前的中风或短暂性脑缺血发作)进行分层的患者亚组中是一致的。中度肾功能不全的患者接受减低的利伐沙班剂量(每天15 mg一次)显示出与肾功能正常的患者每日一次利伐沙班20 mg一致的治疗效果。利伐沙班的耐受性在ROCKET AF中通常是可以接受的,利伐沙班和华法林在重大或非重大临床相关出血事件(主要安全终点)的发生率方面无显着差异。在日本的ROCKET AF试验中,利伐沙班每天15毫克一次(中度肾功能不全患者每天10毫克一次)在重大或非重大临床相关出血发生率方面不次于口服剂量调整的华法林(初步研究结果) 。因此,利伐沙班是华法林的合理替代品,可预防NVAF患者的中风和全身性栓塞。

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