Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes

以兹提米比 辛伐他汀 医学 心肌梗塞 他汀类 内科学 不稳定型心绞痛 安慰剂 胆固醇 临床终点 随机化 联合疗法 胃肠病学 急性冠脉综合征 泌尿科 心脏病学 随机对照试验 替代医学 病理
作者
Christopher P Cannon,Michael A. Blazing,Robert P. Giugliano,Amy McCagg,Jennifer A. White,Pierre Théroux,Harald Darius,Basil S. Lewis,Ton Oude Ophuis,J. Wouter Jukema,Gaetano Maria De Ferrari,Witold Rużyłło,P Lucca,KyungAh Im,Erin A. Bohula,Craig J. Reist,Stephen D. Wiviott,Andrew M. Tershakovec,Thomas A. Musliner,Eugene Braunwald,Robert M. Califf
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:372 (25): 2387-2397 被引量:3493
标识
DOI:10.1056/nejmoa1410489
摘要

Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known.We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years.The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P=0.016). Rates of prespecified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups.When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit. (Funded by Merck; IMPROVE-IT ClinicalTrials.gov number, NCT00202878.).
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