High-dose atorvastatin vs usual dose simvastatin for secondary prevention after myocardial infarction - The IDEAL study: A randomized controlled trial
High-dose atorvastatin vs usual dose simvastatin for secondary prevention after myocardial infarction - The IDEAL study: A randomized controlled trial
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DOI：
10.1001/jama.294.19.2437
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发表时间：
2005-11-16
影响因子：
120.7
通讯作者：
Tsai, J
中科院分区：
文献类型：
--
作者：
Pedersen, TR;Faergeman, O;Tsai, J
背景：有证据表明，与临床常用的低密度脂蛋白胆固醇（LDL-C）相比，更密集的降低将为稳定型冠状动脉疾病提供进一步的益处。目的比较两种降脂策略对既往心肌梗死（MI）患者发生心血管疾病风险的影响。设计、环境和参与者IDEAL研究是一项前瞻性、随机、开放标签、盲法终点评价试验，于1999年3月至2005年3月在北欧190名门诊心脏病护理和专科诊所进行，中位随访时间为4.8年，纳入8888名年龄在80岁或以下、有急性心肌梗死病史的患者。干预措施患者随机分配接受高剂量阿托伐他汀(80mg /d；N =4439)，或常规剂量辛伐他汀（20mg /d; N =4449）。主要结局指标主要冠状动脉事件的发生，定义为冠状动脉死亡、确诊的非致死性急性心肌梗死或心脏骤停伴复苏。结果治疗期间辛伐他汀组患者LDL-C均值为104 (SE, 0.3) mg/dL，阿托伐他汀组患者LDL-C均值为81 (SE, 0.3) mg/dL。463名辛伐他汀患者（10.4%）和411名阿托伐他汀患者（9.3%）发生了主要冠状动脉事件（风险比[HR]， 0.89; 95% Cl, 0.78-1.01； P= 0.07）。两组非致死性急性心肌梗死发生率分别为321例（7.2%）和M7例（6.0%）（HR, 0.83; 95% Cl, 0.71-0.98； P= 0.02），但主要终点的其他2个组成部分无差异。两组主要心血管事件发生率分别为608例和533例（HR = 0.87; 95% Cl = 0.77-0.98； P= 0.02）。1059名辛伐他汀患者和898名阿托伐他汀患者报告发生任何冠状动脉事件(HR, 0.84; 95% Cl, 0.76-0.91； P
Context Evidence suggests that more intensive lowering of low-density lipoprotein cholesterol (LDL-C) than is commonly applied clinically will provide further benefit in stable coronary artery disease.Objective To compare the effects of 2 strategies of lipid lowering on the risk of cardiovascular disease among patients with a previous myocardial infarction (MI).Design, Setting, and Participants The IDEAL study, a prospective, randomized, open-label, blinded end-point evaluation trial conducted at 190 ambulatory cardiology care and specialist practices in northern Europe between March 1999 and March 2005 with a median follow-up of 4.8 years, which enrolled 8888 patients aged 80 years or younger with a history of acute MI.Interventions Patients were randomly assigned to receive a high dose of atorvastatin (80 mg/d; n=4439), or usual-dose simvastatin (20 mg/d; n=4449).Main Outcome Measure Occurrence of a major coronary event, defined as coronary death, confirmed nonfatal acute MI, or cardiac arrest with resuscitation.Results During treatment, mean LDL-C levels were 104 (SE, 0.3) mg/dL in the simvastatin group and 81 (SE, 0.3) mg/dL in the atorvastatin group. A major coronary event occurred in 463 simvastatin patients (10.4%) and in 411 atorvastatin patients (9.3%) (hazard ratio [HR], 0.89; 95% Cl, 0.78-1.01; P=.07). Nonfatal acute MI occurred in 321 (7.2%) and M7 (6.0%) in the 2 groups (HR, 0.83; 95% Cl, 0.71-0.98; P=.02), but no differences were seen in the 2 other components of the primary end point. Major cardiovascular events occurred in 608 and 533 in the 2 groups, respectively (HR, 0.87; 95% Cl, 0.77-0.98; P=.02). Occurrence of any coronary event was reported in 1059 simvastatin and 898 atorvastatin patients (HR, 0.84; 95% Cl, 0.76-0.91; P