口服西米拉加特兰用于心肌梗塞后的二次预防:ESTEEM随机对照试验
Lars Wallentin1, Robert G Wilcox, W Douglas Weaver
1Uppsala Clinical Research Centre, University Hospital, Uppsala, Sweden. lars.wallentin@ucr.uu.se
与阿司匹林结合的西米拉加特兰有效地预防了最近心肌梗塞患者的主要心血管事件. 与单独使用阿司匹林相比,这种口服直接血栓抑制剂可显著减少复发性缺血事件.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 复发性缺血事件构成急性冠状动脉综合征后显著风险.
- 需要有效的策略来预防早期和晚期的心血管事件.
研究的目的:
- 为了评估西米拉加特兰加酸 (阿司匹林) 与单独阿司匹林的疗效.
- 评估预防死亡,非致命的心肌梗塞和心肌梗塞后重复性严重缺血的情况.
主要方法:
- 一项安慰剂控制的双盲多国性研究,涉及1883名近期心肌梗塞患者.
- 患者接受了乙撒利酸 (每天160毫克),并随机分配给口服西米拉加特兰 (每天两次24-60毫克) 或安慰剂6个月.
- 主要疗效结局:对于死亡,非致命性心脏病发作和严重的复发性缺血症,西米拉加特兰与安慰剂的剂量反应关系;治疗意图分析.
主要成果:
- 与安慰剂相比,组合西米拉加特兰组显著降低了24%的初级终点风险 (12.7%对比16.3%,HR 0.76,p=0.036).
- 在西米拉加特兰剂量之间没有观察到显著的剂量反应关系.
- 主要出血事件在结合西米拉加特兰和安慰剂组之间很少发生,并且相似 (1.8%与0.9%).
结论:
- 使用西米拉加特兰和阿司匹林的口服直接血栓抑制比单独使用阿司匹林更有效地预防重大心血管事件.
- 齐米拉加特兰表现出良好的安全性,没有与该药物相关的严重不良事件.
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