阿利罗库马布对急性冠状动脉综合征后死亡率的影响
Philippe Gabriel Steg1,2, Michael Szarek3, Deepak L Bhatt4
1Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France (P.G.S.).
Circulation
|May 24, 2019
概括
在急性冠状动脉综合征患者中,阿利罗库马布显著降低了全因死亡,特别是治疗时间较长或LDL胆固醇水平较低. 在高危心血管患者中,这种PCSK9抑制剂具有潜在的死亡益处.
科学领域:
- 心脏病学
- 药理学
- 临床试验
背景情况:
- 之前的蛋白转化酶9型抑制剂 (PCSK9) 试验显示心血管事件减少,但死亡率没有降低.
- 在ODYSSEY OUTCOMES试验中,研究了阿里古马布对急性冠状动脉综合征 (ACS) 死亡的影响.
研究的目的:
- 评估阿里古马布对所有原因死亡率及其组分在ACS后的患者的影响.
- 评估达到的低密度脂蛋白胆固醇 (LDL-C) 水平与死亡益处之间的关系.
主要方法:
- 这是一项双盲随机试验,涉及18924名近期患有ACS和升高的LDL- C,接受了他类药物治疗.
- 对阿利罗库马布的剂量进行了定位,以达到25- 50mg/ dL之间的LDL- C;结果与安慰剂进行了比较.
- 使用Log-rank测试和关节半参数模型分析死亡和心血管事件.
主要成果:
- 在中位数为2. 8年的随访期内,alirocumab减少了全因死亡 (HR 0. 85,P=0. 03).
- 在对≥3年随访的患者进行预规定的分析时,观察到显著的死亡益处 (HR 0.78,P=0.01).
- 患者的LDL- C基线≥100 mg/ dL,LDL- C水平约为30 mg/ dL的患者的死亡率降低较大.
结论:
- 当阿利罗库马布添加到密集型他类药物治疗中时,可能会降低ACS后的死亡率.
- 治疗持续时间≥3年,基线LDL- C≥100 mg/ dL,并达到较低的LDL- C水平增加了死亡率的好处.
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