LDL-cholesterol lowering with evolocumab, and outcomes according to age and sex in patients in the FOURIER Trial

医学 Evolocumab公司 临床终点 危险系数 内科学 不稳定型心绞痛 心肌梗塞 安慰剂 心脏病学 比例危险模型 冲程(发动机) 置信区间 PCSK9 临床试验 胆固醇 脂蛋白 载脂蛋白A1 替代医学 病理 工程类 机械工程 低密度脂蛋白受体
作者
Peter Sever,Ioanna Gouni‐Berthold,Anthony Keech,Robert P. Giugliano,Terje R. Pedersen,KyungAh Im,Huei Wang,Beat Knüsel,Marc S. Sabatine,Michelle L. O’Donoghue
出处
期刊:European Journal of Preventive Cardiology [Oxford University Press]
卷期号:28 (8): 805-812 被引量:51
标识
DOI:10.1177/2047487320902750
摘要

Some trials have reported diminished efficacy for statins in the elderly, and in women compared with men. We examined the efficacy and safety of evolocumab by patient age and sex in the FOURIER trial, the first major cardiovascular outcome trial of a PCSK9 inhibitor.FOURIER was a randomised, double blind trial, comparing evolocumab with placebo in 27,564 patients with atherosclerotic cardiovascular disease receiving statin therapy (median follow-up 2.2 years). The primary endpoint was cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina or coronary revascularisation. Cox proportional hazards models were used to assess the efficacy of evolocumab versus placebo stratified by quartiles of patient age and by sex. There were small variations in the cardiovascular event rate across the age range (for the primary endpoint, Kaplan-Meier at 3 years 15.6%, >69 years, vs. 15.1%, ≤56 years, P = 0.45); however, the relative efficacy of evolocumab was consistent regardless of patient age (for the primary endpoint (Q1 hazard ratio, 95% confidence interval) 0.83, 0.72-0.96, Q2 0.88, 0.76-1.01, Q3 0.82, 0.71-0.95, Q4 0.86, 0.74-1.00; Pinteraction = 0.91), and the key secondary endpoint (cardiovascular death, myocardial infarction, stroke) (Q1 0.74 (0.61-0.89), Q2 0.83 (0.69-1.00), Q3 0.78 (0.65-0.94), Q4 0.82 (0.69-0.98)); Pinteraction = 0.81). Women had a lower primary endpoint rate than men (Kaplan-Meier at 3 years 12.5 vs. 15.3%, respectively, P < 0.001). Relative risk reductions in the primary endpoint and key secondary endpoint were similar in women (0.81 (0.69-0.95) and 0.74 (0.61-0.90), respectively) compared with men (0.86 (0.80-0.94) and 0.81 (0.73-0.90), respectively), Pinteraction = 0.48 and 0.44, respectively. Adverse events were more common in women and with increasing age but, with the exception of injection site reactions, there were no important significant differences reported by those assigned evolocumab versus placebo.The efficacy and safety of evolocumab are similar throughout a broad range of ages and in both men and women.
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