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用Evolocumab降低低密度脂蛋白胆固醇和周围动脉疾病患者的结果:FOURIER试验的见解 (在高风险患者中使用PCSK9抑制进行进一步的心血管结果研究)

Marc P Bonaca¹, Patrice Nault², Robert P Giugliano³

¹Thrombolysis In Myocardial Infarction Study Group, Brigham and Women's Hospital Heart & Vascular Center, Boston, MA (M.P.B., R.P.G., E.K., J.K., M.S.S.) mbonaca@partners.org.

|November 15, 2017

概括

在患有外周动脉疾病 (PAD) 的患者中,PCSK9抑制剂Evolocumab显著减少了心血管事件和主要不良事件. 在高风险的PAD患者中,这种疗法可显著降低风险.

科学领域:

心血管医学
药理学

背景情况:

周围动脉疾病 (PAD) 与心血管风险增加有关.
像evolocumab这样的proprotein转化酶9型 (PCSK9) 抑制剂可以有效降低LDL胆固醇.
在FOURIER试验中评估了evolocumab对动脉样硬化的患者心血管结果的影响.

研究的目的:

在患有外周动脉疾病 (PAD) 的患者中评估evolocumab的疗效和安全性.
研究evolcumab对PAD患者主要不良事件的影响.
在FOURIER试验中分析evolocumab对PAD患者心血管事件的影响.

主要方法:

这项FOURIER试验是一项随机化,安慰剂对照的研究,对27564名接受他类药物治疗的患者进行了研究.
患有PAD的患者通过间歇性关节损伤与脚指数<0. 85或之前的外周血管手术来确定.
主要终点:结合心血管死亡,心脏病发作,中风,不稳定的心痛或冠状动脉再血管. 关键次要终点:心血管死亡,心脏病发作或中风的综合结果. 额外的结果:主要的肢体不良事件.

主要成果:

13. 2% 的患者患有PAD; 埃沃洛库马布显著降低了PAD患者 (HR 0. 79) 和没有PAD患者 (HR 0. 86) 的初级终点.
在PAD (HR 0. 73) 和非PAD (HR 0. 81) 组中,Evolocumab显著降低了关键的次要终点.
所有患者的evolocumab主要不良事件都减少了 (HR为0. 58),风险降低与低LDL胆固醇水平相关,甚至低于10 mg/ dL.

结论:

在高风险的PAD患者中,Evolocumab显著降低心血管事件的风险,从而显著降低绝对风险.
使用evolocumab抑制PCSK9有效降低主要肢体不良事件的风险.
获得非常低的LDL胆固醇水平 (< 10 mg/ dL) 与降低肢体事件的风险有关.

关键词:

人类PCSK9蛋白截肢动脉样硬化胆固醇,LDL 其他药物间歇性关闭周围动脉疾病

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