新真实世界分析：卒中预防达比加群比利伐沙班大出血风险更低

2016-10-15 03:40| 发布者: 美通社| 查看: 1052| 评论: 0

德国殷格翰2016年10月13日电 /美通社/ -- 一项由美国FDA研究者所做的大型观察性研究发现，在房颤患者中勃林格殷格翰的达比加群酯（150mg每日两次）与利伐沙班（20mg一天一次）相比，颅内出血和包含胃肠道大出血在内的大出血更低。¹该研究是迄今为止比较这两个药物的最大的观察性研究，分析了来自118,000多名患者的数据。¹基于《JAMA内科杂志》发表的数据，在撰写的编者述评中Parks和Redberg建议医生应该“为房颤患者优先处方达比加群酯，而不是利伐沙班”。²

该研究由FDA的Graham及其同事完成，研究回顾性地比较了118,891名房颤（最常见的心律失常）患者的卒中风险、出血风险及死亡风险。研究的主要结果是：¹

达比加群酯150mg与利伐沙班20mg相比，出血风险显著更低，包括大出血、胃肠道大出血及颅内出血
关于研究的其它主要终点，即栓塞性卒中和死亡，两种药物之间无统计学差异
对于次要终点，两种药物相当，或达比加群酯150mg更佳

“这项最新的分析清晰地突现了达比加群酯在日常临床应用中有利的安全性特征及对广泛房颤患者人群的获益。”勃林格殷格翰心血管领域医学副总裁Jorg Kreuzer 教授说，“该研究为医生为了患者的最大利益做出治疗选择提供了宝贵的信息。它证实了今年早些时候发表的其它真实世界数据，为丰富的、支持达比加群酯有利的安全性和有效性特征的证据库又增添了新的内容。”

达比加群酯有利的安全性特征最初通过RE-LY(R)研究确立³^，⁴，之后在真实世界的临床应用中被来自不同渠道的一系列研究反复证实^5-18。另外，达比加群酯是唯一一个拥有已获批并广泛可及的特异性逆转剂的非维生素K拮抗剂口服抗凝药^*。特异性逆转剂用于需要快速逆转抗凝作用的紧急情况。^19,20目前，Idarucizumab (Praxbind（R）) 在全世界超过5500家医院有备货，包括了欧洲的2500多家医院。²¹

* 该特异性逆转剂尚未在中国获批

关于来自美国FDA的Graham及其同事所做的，发表于《JAMA内科杂志》的研究

该回顾性、观察性真实世界研究比较了118,891名接受达比加群酯和利伐沙班治疗的非瓣膜型房颤患者的卒中风险、出血风险及死亡风险，这些患者都来自美国、是Medicare医保的受益人。入组时间为2011年11月到2014年6月，所有患者都是老年患者 (年龄在65岁以上)，许多患者有并发症。共有52,240 名达比加群酯患者和 66,651名利伐沙班患者纳入这项回顾性新使用者队列分析。基线特征的差异基于倾向指数通过使用稳定的治疗权重的逆概率进行了调整。所有患者均为首次治疗的患者，之前使用过华法林或任何非维生素K拮抗剂口服抗凝药的患者都被排除了。患者接受标准剂量的达比加群酯（150mg一天两次）和利伐沙班（20mg一天一次）治疗。该研究是美国FDA和Medicare &Medicaid医保服务中心共同发起的一个项目的一部分。¹

参考文献

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