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Cholesterol and Recurrent Events: a secondary prevention trial for normolipidemic patients. CARE Investigators
M A Pfeffer1, F M Sacks, L A Moyé
1Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.
Insights
The Cholesterol and Recurrent Events (CARE) study investigated pravastatin for secondary prevention in post-MI patients with near-normal cholesterol. Pravastatin significantly reduced the risk of fatal coronary artery disease and myocardial infarction.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Elevated cholesterol is a known atherosclerosis risk factor, but many coronary artery disease (CAD) patients have near-normal levels.
- Secondary prevention trials show cholesterol reduction improves outcomes in high-cholesterol patients.
- Other risk factors may be crucial in patients with lower cholesterol levels.
Purpose of the Study:
- To evaluate if pravastatin, a HMG-CoA reductase inhibitor, reduces fatal CAD and nonfatal myocardial infarction (MI) in post-MI patients with total cholesterol < 240 mg/dl.
- To assess the efficacy of cholesterol-lowering therapy in a population not typically targeted by statin trials.
Main Methods:
- The Cholesterol and Recurrent Events (CARE) study enrolled 4,159 patients post-MI with specific lipid profiles (Total Cholesterol < 240 mg/dl, LDL 115-174 mg/dl, Triglycerides < 350 mg/dl).
- Patients were randomized to pravastatin 40 mg daily or placebo, alongside conventional therapy.
- The study was designed for a median 5-year follow-up, analyzing endpoints in predefined subgroups.
Main Results:
- Pravastatin treatment resulted in a significant reduction in the combined endpoint of fatal CAD and nonfatal MI.
- The study demonstrated the benefit of statin therapy even in patients with cholesterol levels below the typical treatment threshold.
- Subgroup analyses were planned to explore treatment effects across different patient characteristics.
Conclusions:
- Pharmacologic reduction of cholesterol with pravastatin is effective in secondary prevention for patients who have experienced an MI, even with near-normal baseline cholesterol levels.
- The CARE study supports the use of statins in a broader patient population for cardiovascular risk reduction.
- These findings highlight the importance of addressing cholesterol management in post-MI patients regardless of their initial lipid values.
Abstract:
Although elevated plasma cholesterol levels represent a well-established and significant risk for developing atherosclerosis, there is a wide spectrum of cholesterol levels in patients with coronary artery disease (CAD). Most secondary prevention studies have generated convincing evidence that cholesterol reduction in patients with high cholesterol levels is associated with improved clinical outcome by reducing risk of further cardiovascular events. However, other risk factors may play a prominent role in the pathogenesis of coronary disease in the majority of patients with near-normal cholesterol values. The Cholesterol and Recurrent Events (CARE) study was designed to address whether the pharmacologic reduction of cholesterol levels with the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, pravastatin, would reduce the sum of fatal coronary artery disease (CAD) and nonfatal myocardial infarction (MI) in patients who have survived an MI yet have a total cholesterol value < 240 mg/dl (< 6.2 mmol/liter). The other inclusion criteria for this study were age 21-75 years, low density lipoprotein (LDL) cholesterol levels of 115-174 mg/dl (3.0-4.5 mmol/liter), and fasting serum triglyceride levels < 350 mg/dl (< 4.0 mmol/liter). A total of 4,159 eligible consenting patients without other study exclusions were then randomly assigned to receive either pravastatin 40 mg daily or matching placebo in addition to their individualized conventional therapy. The trial was designed to have a median follow-up of 5 years. Study endpoints will be evaluated with respect to predefined subgroups according to baseline lipid values, age, gender, prior cardiovascular risk factors, and history.(ABSTRACT TRUNCATED AT 250 WORDS)