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Effect of Pravastatin on Cardiovascular Events in Older Patients with Myocardial Infarction and Cholesterol Levels in the Average Range: Results of the Cholesterol and Recurrent Events (CARE) Trial

Sandra J. Lewis, MD; Lemuel A. Moye, MD, PhD; Frank M. Sacks, MD; David E. Johnstone, MD; Gerald Timmis, MD; Jayne Mitchell, MS, ANP; Marian Limacher, MD; Sherron Kell, MD, MPH; Stephen P. Glasser, MD; Jane Grant, RN; Barry R. Davis, MD, PhD; Marc A. Pfeffer, MD, PhD; and Eugene Braunwald, MD
[+] Article and Author Information

For the CARE Investigators For author affiliations and current author addresses, see end of text. Grant Support: By an investigator-initiated grant from Bristol-Myers Squibb. Requests for Reprints: Sandra J. Lewis, MD, Legacy Health System, Portland Cardiovascular Institute, 2222 NW Lovejoy Street, Portland, OR 97210. Current Author Addresses: Dr. Lewis: Legacy Health System, Portland Cardiovascular Institute, 2222 NW Lovejoy Street, Portland, OR 97210.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1998;129(9):681-689. doi:10.7326/0003-4819-129-9-199811010-00002
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Background: A majority of all myocardial infarctions occur in patients who are 65 years of age or older and have average cholesterol levels, but little information is available on whether cholesterol lowering in such patients reduces the rate of recurrent cardiovascular disease.

Objective: To determine whether pravastatin reduces the rate of recurrent cardiovascular events in older patients.

Design: Subset analysis of a randomized, controlled trial.

Setting: 80 hospitals and affiliates in the United States and Canada.

Patients: 1283 patients aged 65 to 75 years who had had myocardial infarction and had a plasma total cholesterol level less than 6.2 mmol/L (240 mg/dL) and a low-density lipoprotein cholesterol level of 3.0 to 4.5 mmol/L (115 to 174 mg/dL).

Intervention: Pravastatin, 40 mg/d, or placebo.

Measurements: Five-year event rates of major coronary events (coronary death, nonfatal myocardial infarction, angioplasty, or bypass surgery) and stroke.

Results: Major coronary events occurred in 28.1% of placebo recipients and 19.7% of pravastatin recipients (difference, 9.0 percentage points [95% CI, 4 to 13 percentage points]; relative risk reduction, 32%; P < 0.001). Coronary death occurred in 10.3% of the placebo group and in 5.8% of the pravastatin group (difference, 4.6 percentage points [CI, 1.9 to 6.5 percentage points]; relative risk reduction, 45%; P = 0.004). Stroke incidence was 7.3% in the placebo group and 4.5% in the pravastatin group (absolute reduction, 2.9 percentage points [CI, 0.3 to 4.5 percentage points]; relative reduction, 40%; P = 0.03). The numbers of older patients needed to treat for 5 years were 11 (CI, 8 to 24) to prevent a major coronary event and 22 (CI, 15 to 53) to prevent a coronary death. For every 1000 older patients treated, 225 cardiovascular hospitalizations would be prevented compared with 121 hospitalizations in 1000 younger patients.

Conclusions: In older patients with myocardial infarction and cholesterol levels in the average range, pravastatin is associated with a clinically important reduction in risk for major coronary events and stroke. Given the high cardiovascular event rate in older patients, the potential for absolute benefit in this age group is substantial.

Figures

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Figure 2.
Kaplan-Meier estimates of the incidence of coronary events in patients younger than 65 years of age or 65 to 75 years of age.PP

Coronary events are fatal coronary heart disease, nonfatal myocardial infarction, coronary artery bypass grafting, and angioplasty. The percentage relative risk reductions attributable to pravastatin are given above the values. values and risk reduction are based on Cox proportional-hazards analysis.

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Figure 3.
Kaplan-Meier estimates of the incidence of coronary events in men and women at least 65 years of age.PP

Coronary events are defined as fatal coronary heart disease, nonfatal myocardial infarction, coronary artery bypass grafting, and angioplasty. The percentage relative risk reductions attributable to pravastatin are given above the value. values and risk reduction are based on Cox proportional-hazards analysis.

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Figure 1.
Low-density lipoprotein (LDL) cholesterol levels in patients younger than 65 years of age and those at least 65 years of age.
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