Randomized Evaluation of the Effects of Anacetrapib through Lipid-modification (REVEAL)-A large-scale, randomized, placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease: Trial design, recruitment, and baseline characteristics
Randomized Evaluation of the Effects of Anacetrapib through Lipid-modification (REVEAL)-A large-scale, randomized, placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease: Trial design, recruitment, and baseline characteristics
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DOI：
10.1016/j.ahj.2017.02.021
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发表时间：
2017-05-01
影响因子：
4.8
通讯作者：
Landray, M. J.
中科院分区：
文献类型：
--
作者：
Bowman, L.;Chen, F.;Landray, M. J.
背景既往有血管疾病的患者尽管接受了强化的他汀类药物治疗，但仍处于心血管事件的高风险中。Anacetrapib对胆固醇酯转移蛋白的抑制可使低密度脂蛋白（LDL）胆固醇降低约25%至40%，使高密度脂蛋白（HDL）胆固醇增加一倍以上。然而，目前尚不清楚，如果这些明显有利的脂质变化转化为减少心血管事件。方法的REVEAL研究是一项随机，双盲，安慰剂对照的临床试验，是评估的有效性和安全性，增加anacetrapib有效的降LDL治疗与阿托伐他汀平均至少4年的患者与预先存在的动脉粥样硬化性血管疾病。主要评估是在所有随机化参与者中进行意向治疗比较，比较分配至安塞曲匹对主要冠状动脉事件的影响结果2011年8月至2013年10月，欧洲、北美、和中国随机接受每日100 mg anacetrapib或匹配的安慰剂。平均（SD）年龄为67（8）岁，84%为男性，88%有冠心病病史，22%有脑血管疾病，37%有糖尿病。在随机化访问时（在方案定义的阿托伐他汀方案至少8周后），平均血浆LDL胆固醇为61（15）mg/dL，HDL胆固醇为40（10）mg/dL。预计2017年将取得成果。
Background Patients with prior vascular disease remain at high risk for cardiovascular events despite intensive statin based treatment. Inhibition of cholesteryl ester transfer protein by anacetrapib reduces low-density lipoprotein (LDL) cholesterol by around 25% to 40% and more than doubles high-density lipoprotein (HDL) cholesterol. However, it is not known if these apparently favorable lipid changes translate into reductions in cardiovascular events.Methods The REVEAL study is a randomized, double-blind, placebo-controlled clinical trial that is assessing the efficacy and safety of adding anacetrapib to effective LDL-lowering treatment with atorvastatin for an average of at least 4 years among patients with preexisting atherosclerotic vascular disease. The primary assessment is an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib on major coronary events (defined as the occurrence of coronary death, myocardial infarction, or coronary revascularization).Results Between August 2011 and October 2013, 30,449 individuals in Europe, North America, and China were randomized to receive anacetrapib 100 mg daily or matching placebo. Mean (SD) age was 67 (8) years, 84% were male, 88% had a history of coronary heart disease, 22% had cerebrovascular disease, and 37% had diabetes mellitus. At the randomization visit (after at least 8 weeks on a protocol-defined atorvastatin regimen), mean plasma LDL cholesterol was 61 (15) mg/dL and HDL cholesterol was 40 (10) mg/dL.Interpretation The REVEAL trial will provide a robust evaluation of the clinical efficacy and safety of adding anacetrapib to an effective statin regimen. Results are anticipated in 2017.