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PMID: 8801446 Published · ppublish English Clinical Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators.

The New England journal of medicine ·Vol. 335 ·No. 14 ·1996-10-03 ·Pages 1001-9

Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E

Abstract

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.

MeSH Terms
Adult Aged Angioplasty, Balloon, Coronary Anticholesteremic Agents/therapeutic use Cholesterol/blood Cholesterol, LDL/blood,drug effects Coronary Artery Bypass Coronary Disease/mortality,prevention & control,therapy Double-Blind Method Female Humans Incidence Male Middle Aged Myocardial Infarction/drug therapy,epidemiology Pravastatin/therapeutic use Recurrence Survival Analysis Treatment Outcome
Chemicals
Anticholesteremic Agents Cholesterol, LDL Cholesterol Pravastatin
Authors & Affiliations
12 authors, click to expand affiliations / ORCID
Sacks F M
Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.
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
Article Info
Journal
The New England journal of medicine
Abbr.
N Engl J Med
ISSN
0028-4793
Published
1996-10-03
Pages
1001-9
Language
English
Region
United States
NLM ID
0255562
Subset
IM
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