Fm. Sacks et al., THE EFFECT OF PRAVASTATIN ON CORONARY EVENTS AFTER MYOCARDIAL-INFARCTION IN PATIENTS WITH AVERAGE CHOLESTEROL LEVELS, The New England journal of medicine, 335(14), 1996, pp. 1001-1009
Background In patients with high cholesterol levels, lowering the chol
esterol level reduces the risk of coronary events, but the effect of l
owering cholesterol levels in the majority of patients with coronary d
isease, who have average levels, is less clear. Methods in a double-bl
ind trial lasting five years, we administered either 40 mg of pravasta
tin per day or placebo to 4159 patients (3583 men and 576 women) with
myocardial infarction who had plasma total cholesterol levels below 24
0 mg per deciliter (mean, 209) and low-density lipoprotein (LDL) chole
sterol levels of 115 to 174 mg per deciliter (mean, 139). The primary
end point was a fatal coronary event or a nonfatal myocardial infarcti
on. Results The frequency of the primary end point was 10.2 percent in
the pravastatin group and 13.2 percent in the placebo group, an absol
ute difference of 3 percentage points and a 24 percent reduction in ri
sk (95 percent confidence interval, 9 to 36 percent; P=0.003). Coronar
y bypass surgery was needed in 7.5 percent of the patients in the prav
astatin group and 10 percent of those in the placebo group, a 26 perce
nt reduction (P=0.005), and coronary angioplasty was needed in 8.3 per
cent 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 low
ered 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. Conclusions These results demo
nstrate that the benefit of cholesterol-lowering therapy extends to th
e majority of patients with coronary disease who have average choleste
rol levels. (C) 196 Massachusetts Medical Society.