医学
Evolocumab公司
PCSK9
内科学
危险系数
临床终点
四分位间距
冲程(发动机)
中止
心肌梗塞
心脏病学
不稳定型心绞痛
阿利罗库单抗
代谢综合征
糖尿病
他汀类
以兹提米比
随机对照试验
安慰剂
胆固醇
内分泌学
脂蛋白
置信区间
低密度脂蛋白受体
载脂蛋白A1
机械工程
工程类
肥胖
替代医学
病理
作者
Prakash Deedwania,Sabina A. Murphy,André Scheen,Jolita Badarienė,Armando Lira Pineda,Narimon Honarpour,Anthony Keech,Peter Sever,Terje R. Pedersen,Marc S. Sabatine,Robert P. Giugliano
出处
期刊:JAMA Cardiology
[American Medical Association]
日期:2021-02-01
卷期号:6 (2): 139-139
被引量:48
标识
DOI:10.1001/jamacardio.2020.3151
摘要
The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and cardiovascular events in the FOURIER randomized clinical trial. Patients with metabolic syndrome (MetS) are at increased cardiovascular risk.To investigate outcomes with evolocumab in patients with and without MetS.The FOURIER trial randomized patients worldwide with stable atherosclerotic cardiovascular disease receiving statin to evolocumab vs placebo with follow-up for a median of 2.2 years. Data were collected February 2013 to November 2016. For this prespecified analysis, patients with the requisite data were stratified based on the National Cholesterol Education Program Adult Treatment Panel III MetS criteria; in secondary analyses, patients were further substratified by diabetes at baseline. Analysis was intention to treat. Analysis began March 2018 and ended April 2020.Patients were randomized to evolocumab or placebo.The primary end point was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary end point was cardiovascular death, myocardial infarction, or stroke.Of 27 342 patients (mean [SD] age, 63 [9] years; 20 623 men [75.4%]) included in this analysis, 16 361 (59.8%) with baseline MetS were, when compared with patients without MetS, at higher risk of cardiovascular events (adjusted hazard ratio [95% CI], 1.31 [1.18-1.46]; P < .001 for the primary and 1.38 [1.20-1.57]; P < .001 for the key secondary end point). Evolocumab reduced low-density lipoprotein cholesterol similarly in patients with MetS (median [interquartile range], 92 [79-109] mg/dL vs 30 [19-48] mg/dL; P < .001) and without MetS (median [interquartile range], 92 [81-108] mg/dL vs 29 [18-44] mg/dl; P < .001). For the primary end point, the hazard ratios (95% CI) with evolocumab vs placebo were 0.83 (0.76-0.91) and 0.89 (0.79-1.01) in patients with and without MetS (P for interaction = .39). For the key secondary end point, the corresponding hazard ratios (95% CIs) were 0.76 (0.68-0.86) and 0.86 (0.74-1.01) (P for interaction = .23), respectively. Evolocumab did not increase the risk of new-onset diabetes or other major safety outcomes including worsening glycemic control, compared with placebo in patients with MetS.Patients with atherosclerotic cardiovascular disease and MetS have substantial residual risk of cardiovascular events despite statin therapy. Evolocumab significantly reduced low-density lipoprotein cholesterol and cardiovascular risk in patients with MetS without increasing new-onset diabetes, worsening glycemic control, or other major safety events. These data suggest the addition of evolocumab to statin therapy in patients with atherosclerotic cardiovascular disease and MetS is safe and efficacious to reduce residual cardiovascular risk.ClinicalTrials.gov Identifier: NCT01764633.
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