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首页> 外文OA文献 >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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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

机译：通过脂质修饰（REVEAL）评估Anacetrapib的疗效的随机评估-在已确定的血管疾病患者中进行anacetrapib的临床疗效的大规模，随机，安慰剂对照试验：试验设计，募集和基线特征

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BackgroundPatients 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.MethodsThe 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).ResultsBetween 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.InterpretationThe 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.
机译：背景尽管使用他汀类药物进行了强化治疗，但先前患有血管疾病的患者仍然有发生心血管事件的高风险。 anacetrapib对胆固醇酯转移蛋白的抑制作用使低密度脂蛋白（LDL）胆固醇降低了约25％至40％，是高密度脂蛋白（HDL）胆固醇的两倍以上。然而，尚不清楚这些明显有益的脂质变化是否会导致心血管事件的减少。方法REVEAL研究是一项随机，双盲，安慰剂对照的临床试验，旨在评估将anacetrapib加入有效降低LDL的疗效和安全性。在患有动脉粥样硬化性血管疾病的患者中，使用阿托伐他汀治疗平均至少需要4年。初步评估是在所有随机参与者中进行的意向性治疗比较，研究分配给anacetrapib对主要冠脉事件（定义为发生冠心病死亡，心肌梗塞或冠脉血运重建）的影响。结果2011年8月至2013年10月之间，在欧洲，北美和中国，有30,449人被随机分配为接受100 mg每天服用anacetrapib或相匹配的安慰剂。平均（SD）年龄为67（8）岁，男性为84％，有冠心病病史的为88％，脑血管病为22％，糖尿病为37％。在随机访视时（按照方案定义的阿托伐他汀方案治疗至少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。 anacetrapib加入有效的他汀类药物方案的临床疗效和安全性评估。预计2017年会取得结果。

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