CLINICAL STUDIES
Effect of pravastatin on cardiovascular events in women after myocardial infarction: the Cholesterol and Recurrent Events (CARE) trial
Sandra J. Lewis, MD, FACCa,
Frank M. Sacks, MD*,
Jayne S. Mitchell, MS, ANPa,
Cara East, MD ,
Stephen Glasser, MD, FACC ,
Sheren Kell, MD ,
Rebecca Letterer, RN, BSN||,
Marian Limacher, MD, FACC#,
Lemuel A. Moye, MD, PhD**,
Jean L. Rouleau, MD, FACC,
Marc A. Pfeffer, MD, PhD, FACC*,
Eugene Braunwald, MD, FACC* for the CARE Investigators
a Legacy Good Samaritan Hospital, Portland Cardiovascular Institute, Portland, Oregon, USA
* Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, USA
Baylor University Medical Center, Dallas, Texas, USA
University of South Florida, Tampa, Florida, USA
University of Alabama, Birmingham, Alabama, USA
|| University of Washington Medical Center, Seattle, Washington, USA
# University of Florida Medical Center, Gainesville, Florida, USA
** University of Texas School of Public Health, Houston, Texas, USA
Montreal Heart Institute, Montreal, Quebec, Canada
Manuscript received November 26, 1997;
revised manuscript received March 17, 1998,
accepted April 9, 1998.
Address for correspondence: Dr. Frank Sacks, Nutrition Department, Harvard School of Public Health, 665 Huntington Avenue, Boston, Massachusetts 02115
fsacks{at}hsph.harvard.edu
Objectives. We sought to determine the effect of pravastatin on recurrent cardiovascular events in women with average cholesterol levels after myocardial infarction (MI).
Background. Little information is available on the effectiveness of lipid lowering in secondary prevention of coronary heart disease (CHD) in women; in particular, those with CHD and average cholesterol levels.
Methods. In the Cholesterol and Recurrent Events (CARE) trial, 576 postmenopausal women, between 3 and 20 months after MI, with a total cholesterol level <240 mg/dl and a low density lipoprotein cholesterol level 115 to 174 mg/dl, were randomized to receive pravastatin 40 mg/day or matching placebo for a median follow-up period of 5 years. The main outcome measures were combined coronary events (coronary death, nonfatal MI, percutaneous transluminal coronary angioplasty [PTCA] or coronary artery bypass graft surgery [CABG]), the primary trial end point (coronary death or nonfatal MI) and stroke.
Results. Women treated with pravastatin had a risk reduction of 43% for the primary end point (p = 0.035), 46% for combined coronary events (p = 0.001), 48% for PTCA (p = 0.025), 40% for CABG (p = 0.14) and 56% for stroke (p = 0.07). The 3,583 men in the CARE trial also showed a reduction in risk, but the magnitude tended to be less. Pravastatin improved plasma lipids similarly in men and women. There were no differences in risk of coronary events in the placebo group between men and women. Minor differences between men and women were present in baseline characteristics and treatment for MI, in general, conferring a higher risk status and a lower incidence of CABG in the women.
Conclusions. Pravastatin led to significant early reduction of a wide range of cardiovascular events in post-MI women with average cholesterol levels.
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Abbreviations and Acronyms
| | CABG | = coronary artery bypass graft surgery | | CARE | = Cholesterol and Recurrent Events | | CHD | = coronary heart disease | | HDL | = high density lipoprotein | | HMG CoA | = hydroxymethylglutaryl coenzyme A | | LDL | = low density lipoprotein | | MI | = myocardial infarction | | PTCA | = percutaneous transluminal coronary angioplasty | | 4S | = Scandinavian Simvastatin Survival Study |
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