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心血管事件及其在胆固醇水平正常的糖尿病和糖耐量异常心肌梗死幸存者中使用普伐他汀的降低情况:胆固醇与再发事件(CARE)试验中的亚组分析。CARE研究组

Cardiovascular events and their reduction with pravastatin in diabetic and glucose-intolerant myocardial infarction survivors with average cholesterol levels: subgroup analyses in the cholesterol and recurrent events (CARE) trial. The Care Investigators.

作者信息

Goldberg R B, Mellies M J, Sacks F M, Moyé L A, Howard B V, Howard W J, Davis B R, Cole T G, Pfeffer M A, Braunwald E

机构信息

University of Miami School of Medicine, Miami, FL, USA.

出版信息

Circulation. 1998 Dec 8;98(23):2513-9. doi: 10.1161/01.cir.98.23.2513.

DOI:10.1161/01.cir.98.23.2513
PMID:9843456
Abstract

BACKGROUND

Although diabetes is a major risk factor for coronary heart disease (CHD), little information is available on the effects of lipid lowering in diabetic patients. We determined whether lipid-lowering treatment with pravastatin prevents recurrent cardiovascular events in diabetic patients with CHD and average cholesterol levels.

METHODS AND RESULTS

The Cholesterol And Recurrent Events (CARE) trial, a 5-year trial that compared the effect of pravastatin and placebo, included 586 patients (14.1%) with clinical diagnoses of diabetes. The participants with diabetes were older, more obese, and more hypertensive. The mean baseline lipid concentrations in the group with diabetes--136 mg/dL LDL cholesterol, 38 mg/dL HDL cholesterol, and 164 mg/dL triglycerides--were similar to those in the nondiabetic group. LDL cholesterol reduction by pravastatin was similar (27% and 28%) in the diabetic and nondiabetic groups, respectively. In the placebo group, the diabetic patients suffered more recurrent coronary events (CHD death, nonfatal myocardial infarction [MI], CABG, and PTCA) than did the nondiabetic patients (37% versus 25%). Pravastatin treatment reduced the absolute risk of coronary events for the diabetic and nondiabetic patients by 8.1% and 5.2% and the relative risk by 25% (P=0.05) and 23% (P<0.001), respectively. Pravastatin reduced the relative risk for revascularization procedures by 32% (P=0.04) in the diabetic patients. In the 3553 patients who were not diagnosed as diabetic, 342 had impaired fasting glucose at entry defined by the American Diabetes Association as 110 to 125 mg/dL. These nondiabetic patients with impaired fasting glucose had a higher rate of recurrent coronary events than those with normal fasting glucose (eg, 13% versus 10% for nonfatal MI). Recurrence rates tended to be lower in the pravastatin compared with placebo group (eg, -50%, P=0.05 for nonfatal MI).

CONCLUSIONS

Diabetic patients and nondiabetic patients with impaired fasting glucose are at high risk of recurrent coronary events that can be substantially reduced by pravastatin treatment.

摘要

背景

虽然糖尿病是冠心病(CHD)的主要危险因素,但关于降脂治疗对糖尿病患者影响的信息却很少。我们确定了使用普伐他汀进行降脂治疗是否能预防患有冠心病且胆固醇水平正常的糖尿病患者再次发生心血管事件。

方法与结果

胆固醇与再发事件(CARE)试验是一项为期5年的试验,比较了普伐他汀和安慰剂的效果,其中包括586例临床诊断为糖尿病的患者(占14.1%)。患有糖尿病的参与者年龄更大、更肥胖且高血压患病率更高。糖尿病组的平均基线血脂浓度——低密度脂蛋白胆固醇为136mg/dL、高密度脂蛋白胆固醇为38mg/dL、甘油三酯为164mg/dL——与非糖尿病组相似。普伐他汀使糖尿病组和非糖尿病组的低密度脂蛋白胆固醇分别降低了27%和28%,二者相似。在安慰剂组中,糖尿病患者比非糖尿病患者发生更多的复发性冠脉事件(冠心病死亡、非致命性心肌梗死[MI]、冠状动脉搭桥术[CABG]和经皮冠状动脉腔内血管成形术[PTCA])(37%对25%)。普伐他汀治疗分别使糖尿病患者和非糖尿病患者的冠脉事件绝对风险降低了8.1%和5.2%,相对风险降低了25%(P=0.05)和23%(P<0.001)。普伐他汀使糖尿病患者血管重建术的相对风险降低了32%(P=0.04)。在3553例未被诊断为糖尿病的患者中,有342例在入组时空腹血糖受损,根据美国糖尿病协会的定义,空腹血糖为110至125mg/dL。这些空腹血糖受损的非糖尿病患者复发性冠脉事件的发生率高于空腹血糖正常的患者(例如,非致命性心肌梗死的发生率分别为13%对10%)。与安慰剂组相比,普伐他汀组的复发率往往更低(例如,非致命性心肌梗死降低了50%,P=0.05)。

结论

糖尿病患者以及空腹血糖受损的非糖尿病患者发生复发性冠脉事件的风险很高,而普伐他汀治疗可大幅降低这种风险。

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