HELSINKI HEART-STUDY - PRIMARY-PREVENTION TRIAL WITH GEMFIBROZIL IN MIDDLE-AGED MEN WITH DYSLIPIDEMIA - SAFETY OF TREATMENT, CHANGES IN RISK-FACTORS, AND INCIDENCE OF CORONARY HEART-DISEASE
HELSINKI HEART-STUDY - PRIMARY-PREVENTION TRIAL WITH GEMFIBROZIL IN MIDDLE-AGED MEN WITH DYSLIPIDEMIA - SAFETY OF TREATMENT, CHANGES IN RISK-FACTORS, AND INCIDENCE OF CORONARY HEART-DISEASE
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DOI：
10.1056/nejm198711123172001
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发表时间：
1987-11-12
影响因子：
158.5
通讯作者：
NIKKILA, EA
中科院分区：
文献类型：
--
作者：
FRICK, MH;ELO, O;NIKKILA, EA
在一项为期五年的随机双盲试验中，我们测试了吉非罗齐同时提高血清高密度脂蛋白胆固醇水平和降低非高密度脂蛋白胆固醇水平对4081名无症状的中年男性(40岁至55岁)和原发性血脂异常(非高密度脂蛋白胆固醇)患者降低冠心病风险的效果。每分升200毫克[每升5.2毫克]，连续两次前处理测量)。其中一组(2051名男性)每天两次服用600毫克吉非罗齐，另一组(2030名男性)接受安慰剂治疗。吉非罗齐导致高密度脂蛋白胆固醇显著升高，血清总胆固醇、低密度脂蛋白、非高密度脂蛋白和甘油三酯水平持续下降。安慰剂组的血脂水平变化很小。在吉非罗齐组和安慰剂组中，5年心脏终点的累积发生率分别为27.3/1000和41.4/1000--冠心病发病率降低了34.0%(95%可信区间，8.2至52.6；P<；0.02；双尾检验)。吉非罗齐组的发病率下降在第二年变得明显，并持续到整个研究过程。两组之间的总死亡率没有差异，治疗也没有影响癌症发生率。这一结果与之前用不同药物进行的两项试验相一致，并表明吉非罗齐改变脂蛋白水平降低了患有血脂异常的男性的冠心病发病率。
In a randomized, double-blind five-year trial, we tested the efficacy of simultaneously elevating serum levels of high-density lipoprotein (HDL) cholesterol and lowering levels of non-HDL cholesterol with gemfibrozil in reducing the risk of coronary heart disease in 4081 asymptomatic middle-aged men (40 to 55 years of age) with primary dyslipidemia (non-HDL cholesterol .gtoreq. 200 mg per deciliter [5.2 mmol per liter] in two consecutive pretreatment measurements). One group (2051 men) received 600 mg of gemfibrozil twice daily, and the other (2030 men) received placebo. Gemfibrozil caused a marked increase in HDL cholesterol and persistent reductions in serum levels of total, low-density lipoprotein (LDL), and non-HDL cholesterol and triglycerides. There were minimal changes in serum lipid levels in the placebo group. The cumulative rate of cardiac end points at five years was 27.3 per 1000 in the gemfibrozil group and 41.4 per 1000 in the placebo group - a reduction of 34.0 percent in the incidence of coronary heart disease (95 percent confidence interval, 8.2 to 52.6; P < 0.02; two-tailed test). The decline in incidence in the gemfibrozil group became evident in the second year and continued throughout the study. There was no difference between the groups in the total death rate, nor did the treatment influence the cancer rates. The results are in accord with two previous trials with different pharmacologic agents and indicate that modification of lipoprotein levels with gemfibrozil reduces the incidence of coronary heart disease in men with dyslipidemia.