Pfeffer M A, Sacks F M, Moyé L A, Brown L, Rouleau J L, Hartley L H, Rouleau J, Grimm R, Sestier F, Wickemeyer W
Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.
Am J Cardiol. 1995 Sep 28;76(9):98C-106C. doi: 10.1016/s0002-9149(99)80478-0.
Although elevated plasma cholesterol levels represent a well-established and significant risk for developing atherosclerosis, there is a wide spectrum of cholesterol levels in patients with coronary artery disease (CAD). Most secondary prevention studies have generated convincing evidence that cholesterol reduction in patients with high cholesterol levels is associated with improved clinical outcome by reducing risk of further cardiovascular events. However, other risk factors may play a prominent role in the pathogenesis of coronary disease in the majority of patients with near-normal cholesterol values. The Cholesterol and Recurrent Events (CARE) study was designed to address whether the pharmacologic reduction of cholesterol levels with the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, pravastatin, would reduce the sum of fatal coronary artery disease (CAD) and nonfatal myocardial infarction (MI) in patients who have survived an MI yet have a total cholesterol value < 240 mg/dl (< 6.2 mmol/liter). The other inclusion criteria for this study were age 21-75 years, low density lipoprotein (LDL) cholesterol levels of 115-174 mg/dl (3.0-4.5 mmol/liter), and fasting serum triglyceride levels < 350 mg/dl (< 4.0 mmol/liter). A total of 4,159 eligible consenting patients without other study exclusions were then randomly assigned to receive either pravastatin 40 mg daily or matching placebo in addition to their individualized conventional therapy. The trial was designed to have a median follow-up of 5 years. Study endpoints will be evaluated with respect to predefined subgroups according to baseline lipid values, age, gender, prior cardiovascular risk factors, and history.(ABSTRACT TRUNCATED AT 250 WORDS)
尽管血浆胆固醇水平升高是动脉粥样硬化发生的一个既定且重要的风险因素，但冠心病（CAD）患者的胆固醇水平范围很广。大多数二级预防研究已产生令人信服的证据表明，高胆固醇水平患者降低胆固醇与通过降低进一步心血管事件风险而改善临床结局相关。然而，在大多数胆固醇值接近正常的患者中，其他风险因素可能在冠心病发病机制中起主要作用。胆固醇与再发事件（CARE）研究旨在探讨用3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂普伐他汀进行药物性降低胆固醇水平是否会降低心肌梗死（MI）幸存者且总胆固醇值<240mg/dl（<6.2mmol/L）患者的致命性冠状动脉疾病（CAD）和非致命性心肌梗死（MI）的总和。本研究的其他纳入标准为年龄21 - 75岁、低密度脂蛋白（LDL）胆固醇水平为115 - 174mg/dl（3.0 - 4.5mmol/L）以及空腹血清甘油三酯水平<350mg/dl（<4.0mmol/L）。然后，共有4159名符合条件且无其他研究排除标准的同意患者被随机分配接受每日40mg普伐他汀或匹配的安慰剂，同时接受个体化常规治疗。该试验设计的中位随访期为5年。将根据基线血脂值、年龄、性别、既往心血管风险因素和病史，针对预定义亚组评估研究终点。（摘要截断于250字）
