Shepherd J, Cobbe S M, Ford I, Isles C G, Lorimer A R, MacFarlane P W, McKillop J H, Packard C J
Department of Pathological Biochemistry, University of Glasgow, Scotland.
N Engl J Med. 1995 Nov 16;333(20):1301-7. doi: 10.1056/NEJM199511163332001.
Lowering the blood cholesterol level may reduce the risk of coronary heart disease. This double-blind study was designed to determine whether the administration of pravastatin to men with hypercholesterolemia and no history of myocardial infarction reduced the combined incidence of nonfatal myocardial infarction and death from coronary heart disease.
We randomly assigned 6595 men, 45 to 64 years of age, with a mean (+/- SD) plasma cholesterol level of 272 +/- 23 mg per deciliter (7.0 +/- 0.6 mmol per liter) to receive pravastatin (40 mg each evening) or placebo. The average follow-up period was 4.9 years. Medical records, electrocardiographic recordings, and the national death registry were used to determine the clinical end points.
Pravastatin lowered plasma cholesterol levels by 20 percent and low-density-lipoprotein cholesterol levels by 26 percent, whereas there was no change with placebo. There were 248 definite coronary events (specified as nonfatal myocardial infarction or death from coronary heart disease) in the placebo group, and 174 in the pravastatin group (relative reduction in risk with pravastatin, 31 percent; 95 percent confidence interval, 17 to 43 percent; P < 0.001). There were similar reductions in the risk of definite nonfatal myocardial infarctions (31 percent reduction, P < 0.001), death from coronary heart disease (definite cases alone: 28 percent reduction, P = 0.13; definite plus suspected cases: 33 percent reduction, P = 0.042), and death from all cardiovascular causes (32 percent reduction, P = 0.033). There was no excess of deaths from noncardiovascular causes in the pravastatin group. We observed a 22 percent reduction in the risk of death from any cause in the pravastatin group (95 percent confidence interval, 0 to 40 percent; P = 0.051).
Treatment with pravastatin significantly reduced the incidence of myocardial infarction and death from cardiovascular causes without adversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of myocardial infarction.
降低血液胆固醇水平可能会降低冠心病风险。这项双盲研究旨在确定给予患有高胆固醇血症且无心肌梗死病史的男性普伐他汀是否能降低非致命性心肌梗死和冠心病死亡的合并发生率。
我们将6595名年龄在45至64岁之间、平均（±标准差）血浆胆固醇水平为每分升272±23毫克（每升7.0±0.6毫摩尔）的男性随机分为两组，分别接受普伐他汀（每晚40毫克）或安慰剂。平均随访期为4.9年。通过病历、心电图记录和国家死亡登记处来确定临床终点。
普伐他汀使血浆胆固醇水平降低了20%，低密度脂蛋白胆固醇水平降低了26%，而安慰剂组则无变化。安慰剂组有248例明确的冠心病事件（定义为非致命性心肌梗死或冠心病死亡），普伐他汀组有174例（普伐他汀治疗使风险相对降低31%；95%置信区间为17%至43%；P<0.001）。明确的非致命性心肌梗死风险也有类似程度的降低（降低31%，P<0.001），冠心病死亡风险（仅明确病例：降低28%，P=0.13；明确病例加疑似病例：降低33%，P=0.042），以及所有心血管病因导致的死亡风险（降低32%，P=0.033）。普伐他汀组非心血管病因导致的死亡没有增加。我们观察到普伐他汀组任何原因导致的死亡风险降低了22%（95%置信区间为0至40%；P=0.051）。
在患有中度高胆固醇血症且无心肌梗死病史的男性中，使用普伐他汀治疗可显著降低心肌梗死和心血管病因导致的死亡发生率，且不会对非心血管病因导致的死亡风险产生不利影响。
