Sacks F M, Pfeffer M A, Moye L A, Rouleau J L, Rutherford J D, Cole T G, Brown L, Warnica J W, Arnold J M, Wun C C, Davis B R, Braunwald E
Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.
N Engl J Med. 1996 Oct 3;335(14):1001-9. doi: 10.1056/NEJM199610033351401.
In patients with high cholesterol levels, lowering the cholesterol level reduces the risk of coronary events, but the effect of lowering cholesterol levels in the majority of patients with coronary disease, who have average levels, is less clear.
In a double-blind trial lasting five years we administered either 40 mg of pravastatin per day or placebo to 4159 patients (3583 men and 576 women) with myocardial infarction who had plasma total cholesterol levels below 240 mg per deciliter (mean, 209) and low-density lipoprotein (LDL) cholesterol levels of 115 to 174 mg per deciliter (mean, 139). The primary end point was a fatal coronary event or a nonfatal myocardial infarction.
The frequency of the primary end point was 10.2 percent in the pravastatin group and 13.2 percent in the placebo group, an absolute difference of 3 percentage points and a 24 percent reduction in risk (95 percent confidence interval, 9 to 36 percent; P = 0.003). Coronary bypass surgery was needed in 7.5 percent of the patients in the pravastatin group and 10 percent of those in the placebo group, a 26 percent reduction (P=0.005), and coronary angioplasty was needed in 8.3 percent of the pravastatin group and 10.5 percent of the placebo group, a 23 percent reduction (P=0.01). The frequency of stroke was reduced by 31 percent (P=0.03). There were no significant differences in overall mortality or mortality from noncardiovascular causes. Pravastatin lowered the rate of coronary events more among women than among men. The reduction in coronary events was also greater in patients with higher pretreatment levels of LDL cholesterol.
These results demonstrate that the benefit of cholesterol-lowering therapy extends to the majority of patients with coronary disease who have average cholesterol levels.
在胆固醇水平高的患者中,降低胆固醇水平可降低冠状动脉事件的风险,但在大多数胆固醇水平处于平均水平的冠心病患者中,降低胆固醇水平的效果尚不清楚。
在一项为期五年的双盲试验中,我们对4159例心肌梗死患者(3583例男性和576例女性)给予每天40毫克普伐他汀或安慰剂,这些患者的血浆总胆固醇水平低于每分升240毫克(平均209毫克),低密度脂蛋白(LDL)胆固醇水平为每分升115至174毫克(平均139毫克)。主要终点是致命性冠状动脉事件或非致命性心肌梗死。
普伐他汀组主要终点的发生率为10.2%,安慰剂组为13.2%,绝对差异为3个百分点,风险降低24%(95%置信区间,9%至36%;P=0.003)。普伐他汀组7.5%的患者需要进行冠状动脉搭桥手术,安慰剂组为10%,降低了26%(P=0.005);普伐他汀组8.3%的患者需要进行冠状动脉血管成形术,安慰剂组为10.5%,降低了23%(P=0.01)。中风发生率降低了31%(P=0.03)。总体死亡率或非心血管原因导致的死亡率没有显著差异。普伐他汀降低女性冠状动脉事件的发生率比男性更多。在治疗前LDL胆固醇水平较高的患者中,冠状动脉事件的减少也更大。
这些结果表明,降胆固醇治疗的益处扩展到了大多数胆固醇水平处于平均水平的冠心病患者。