Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol

Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol
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DOI:
10.1056/nejm199908053410604
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发表时间:
1999-08-05
影响因子:
158.5
通讯作者:
Wittes, J
Wittes, J
中科院分区:
医学1区
文献类型:
--
作者:
Rubins, HB;Robins, SJ;Wittes, J

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背景虽然人们普遍认为降低冠心病患者升高的血清低密度脂蛋白(LDL)胆固醇水平是有益的,对于原发性血脂异常为低水平高密度脂蛋白(HDL)胆固醇的患者,很少有数据可以指导治疗决策。(1200毫克每粘土)与安慰剂在2531名男性冠心病,高密度脂蛋白胆固醇水平为40毫克每分升(1.0 mmol/L)或更少,低密度脂蛋白胆固醇水平为每分升140毫克主要研究结果为非致命性心肌梗死或冠状动脉原因死亡。结果中位随访时间为5.1年。一年后,吉非罗齐组的平均HDL胆固醇水平比安慰剂组高6%,平均甘油三酯水平低31%,平均总胆固醇水平低4%。各组之间的低密度脂蛋白胆固醇水平没有显着差异。在1267名接受安慰剂治疗的患者中有275名(21.7%)和1264名接受吉非罗齐治疗的患者中有219名(17.3%)发生了主要事件。事件风险的总体降低为4.4个百分点,相对风险降低为22%(95%置信区间,7%至35%; P=0.006)。我们观察到冠心病、非致命性心肌梗死和中风死亡的综合结局降低了24%(P
Background Although it is generally accepted that lowering elevated serum levels of low-density lipoprotein (LDL) cholesterol in patients with coronary heart disease is beneficial, there are few data to guide decisions about therapy for patients whose primary lipid abnormality is a low level of high-density lipoprotein (HDL) cholesterol.Methods We conducted a double-blind trial comparing gemfibrozil (1200 mg per clay) with placebo in 2531 men with coronary heart disease, an HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and an LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less. The primary study outcome was nonfatal myocardial infarction or death from coronary causes.Results The median follow-up was 5.1 years. At one year, the mean HDL cholesterol level was 6 percent higher, the mean triglyceride level was 31 percent lower, and the mean total cholesterol level was 4 percent lower in the gemfibrozil group than in the placebo group. LDL cholesterol levels did not differ significantly between the groups. A primary event occurred in 275 of the 1267 patients assigned to placebo (21.7 percent) and in 219 of the 1264 patients assigned to gemfibrozil (17.3 percent). The overall reduction in the risk of an event was 4.4 percentage points, and the reduction in relative risk was 22 percent (95 percent confidence interval, 7 to 35 percent; P=0.006). We observed a 24 percent reduction in the combined outcome of death from coronary heart disease, nonfatal myocardial infarction, and stroke (P