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PCSK9 抑制剂的心血管疗效和安全性:系统评价和荟萃分析,包括 ODYSSEY OUTCOMES 试验。

Cardiovascular Efficacy and Safety of PCSK9 Inhibitors: Systematic Review and Meta-analysis Including the ODYSSEY OUTCOMES Trial.

机构信息

Division of Cardiology, Faculty of Medicine and Dentistry, University of Alberta, Alberta, Canada.

Division of Cardiology, Faculty of Medicine and Dentistry, University of Alberta, Alberta, Canada.

出版信息

Can J Cardiol. 2018 Dec;34(12):1600-1605. doi: 10.1016/j.cjca.2018.04.002.

DOI:10.1016/j.cjca.2018.04.002
PMID:30527147
Abstract

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are efficacious lipid-lowering agents, but more precise estimates of their effects on major adverse cardiovascular events (MACE), mortality, and safety are needed. We systematically reviewed and meta-analyzed randomized controlled trials with durations ≥ 6 months comparing MACE, mortality, and safety with PCSK9 inhibitors vs control. We searched CENTRAL, Embase, MedLine and the grey literature to November 7, 2018. From 2048 articles, we included 23 trials (n = 60,723). PCSK9 inhibitors reduced MACE (relative risk, 0.83; 95% confidence interval, 0.78-0.88), but did not clearly reduce mortality (relative risk, 0.93; 95% confidence interval, 0.85-1.02) or increase adverse events. In conclusion, PCSK9 inhibitors reduce nonfatal MACE, are well tolerated, but effects on mortality remain unclear.

摘要

前蛋白转化酶枯草溶菌素 9(PCSK9)抑制剂是有效的降脂药物,但需要更精确地估计它们对主要不良心血管事件(MACE)、死亡率和安全性的影响。我们系统地检索了 CENTRAL、Embase、MedLine 和灰色文献,检索时间截至 2018 年 11 月 7 日,比较了 PCSK9 抑制剂与对照组相比≥6 个月的随机对照试验的 MACE、死亡率和安全性。从 2048 篇文章中,我们纳入了 23 项试验(n=60723)。PCSK9 抑制剂降低了 MACE(相对风险,0.83;95%置信区间,0.78-0.88),但死亡率(相对风险,0.93;95%置信区间,0.85-1.02)或不良反应发生率并未明显降低。总之,PCSK9 抑制剂可减少非致死性 MACE,且耐受性良好,但对死亡率的影响仍不清楚。

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