CHMP支持百时美及辉瑞Eliquis(阿哌沙班)产品特征概要补充

关键词:阿哌沙班,百时美施贵宝,辉瑞,Eliquis,房颤,复律

2014年5月5日讯 /生物谷BIOON/ --欧洲药品管理局(EMA)人用医药产品委员会(CHMP)5月2日支持批准百时美施贵宝(BMS)和辉瑞(Pfizer)对抗凝剂Eliquis(apixaban,阿哌沙班)目前产品特征概要(药品说明书,SmPC)的补充,该补充指出“在接受复律时,患者可继续服用阿哌沙班。”

心脏电复律(cardioversion)指在严重快速型心律失常时,用外加的高能量脉冲电流通过心脏,使全部或大部分心肌细胞在瞬间同时除极,造成心脏短暂的电活动停止,然后由最高自律性的起搏点(通常为窦房结)重新主导心脏节律的治疗过程。最早用于消除心室颤动,故亦称心脏电除颤。

复律旨在恢复心律失常患者(如房颤,atrial fibrillation,AF)正常的心脏节律。在欧洲,有880万房颤患者,其中许多人接受复律作为其心律失常管理的一部分。

CHMP的积极意见,是基于ARISTOTLE研究结果的事后分析(post-hoc analysis)数据。ARISTOTLE研究在非瓣膜性房颤(NVAF)患者中开展,目的是评估阿哌沙班在预防卒中或全身性栓塞方面相对于华法林的疗效和安全性。该项研究中,540例患者接受了743次复律。研究数据表明,阿哌沙班治疗组和华法林治疗组复律后发生的不良临床实践相当,2组中均未报道中风或全身性栓塞,心肌梗死、严重出血或死亡发生率均很低。

Eliquis SmPC的更新非常重要,因为这意味着NVAF患者在接受复律前,不再必须改变抗凝疗法,阿哌沙班疗法可以继续进行而不必中断。ARISTOTLE研究数据表明,阿哌沙班治疗组无中风和全身性栓塞事件,不良反应率低且在各组之间平衡,这些数据为那些已经在服用阿哌沙班的患者接受复律时继续服用该药提供了保障。

Eliquis是一种Xa因子抑制剂,是唯一一种在中风及全身性栓塞、严重出血、全因死亡率等3个重要预后中与华法林相比表现出卓越风险降低的口服抗凝血剂。

目前,该药已获欧盟及美国在内多个国家批准,用于降低非瓣膜性房颤患者卒中和全身性栓塞风险。此外,该药还获欧盟及一些国家批准,用于已接受择期髋关节或膝关节置换手术成人患者预防静脉血栓栓塞事件(VTE)。(生物谷Bioon.com)

英文原文:EMA advisory committee backs addition for Eliquis SmPC

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended an addition to the current Summary of Product Characteristics (SmPC) for US pharma majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer’s (NYSE: PFE) Eliquis (apixaban) stating that “Patients can stay on apixaban while being cardioverted.”

Cardioversion is a procedure that attempts to restore the normal heart rhythm in patients with arrhythmias such as atrial fibrillation (AF). There are 8.8 million people with AF in Europe (1.2 million of whom are in the UK) many of whom undergo cardioversion as part of their management.

The CHMP’s positive opinion was based on a post-hoc analysis of the outcomes of the ARISTOTLE study. ARISTOTLE was designed to evaluate the efficacy and safety of apixaban compared to warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation (NVAF). In ARISTOTLE, 540 patients underwent 743 cardioversions for NVAF. The outcomes of patients treated with apixaban (n=265) compared to those treated with warfarin (n=275) were assessed in the 30 days following cardioversion attempts. Adverse clinical events occurring after cardioversion were found to be comparable between the warfarin and apixaban groups with no reported stroke or systemic emboli in either group and low observed rates of myocardial infarction, major bleeding or death.

Significant update

“The SmPC update is significant because it means that NVAF patients will no longer have to change anticoagulation therapy prior to cardioversion, and apixaban therapy can now be continued without interruption,” said John Camm, a professor and clinical cardiologist, St George’s Hospital, London, adding: “The fact that this ARISTOTLE analysis showed that there were no strokes or systemic emboli in the apixaban group, and that adverse events were low and balanced between the treatment arms, provides reassurance that patients already taking apixaban who need cardioversion can continue to take this oral anticoagulant while they are being cardioverted.”

(责任编辑:lishuheng)

小编提示:87%用户都在生物谷APP上阅读,扫描立刻下载!

您还可以这样阅读

微信扫一扫,体验新式阅读

打开微信扫描二维码

生物谷微信账号:bioonnews

我们提供多种阅读途径供您选择,随时随地掌握医药生物领域最新资讯。

生物谷微信二维码

    相关资料

    欢迎行业评论、发现、小道消息、官方爆料、采访约稿

    我要投稿   下载App支持编辑