Cardiovascular outcome trial · N Engl J Med 1996
CARE trial
The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators.
The bottom line
In patients with average cholesterol levels after myocardial infarction, pravastatin significantly reduced the risk of fatal coronary events and nonfatal MI, as well as the need for revascularization and stroke, without a significant effect on overall mortality.
BenefitUS status: US-approved
At a glance
- Medicine
- 40 mg of pravastatin per day
- Compared with
- Placebo
- People
- 4,159
- Who took part
- Patients with myocardial infarction and plasma total cholesterol levels below 240 mg per deciliter (mean, 209) and LDL cholesterol levels of 115 to 174 mg per deciliter (mean, 139); 3583 men and 576 women
- Design
- double-blind trial
- Follow-up
- five years
- Main question
- A fatal coronary event or a nonfatal myocardial infarction
Main result
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).
Effect on LDL cholesterol
LDL cholesterol levels of 115 to 174 mg per deciliter (mean, 139) at baseline
Other results
There were no significant differences in overall mortality or mortality from noncardiovascular causes. Coronary bypass surgery was reduced by 26 percent (P=0.005), coronary angioplasty by 23 percent (P=0.01), and stroke by 31 percent (P=0.03).
Safety
There were no significant differences in overall mortality or mortality from noncardiovascular causes.
In the trial's own words
“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).”
Quoted from the abstract of N Engl J Med 1996, checked word for word against PubMed. PubMed 8801446 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the CARE trial find?
In patients with average cholesterol levels after myocardial infarction, pravastatin significantly reduced the risk of fatal coronary events and nonfatal MI, as well as the need for revascularization and stroke, without a significant effect on overall mortality.
Who was in CARE?
4,159 people. Patients with myocardial infarction and plasma total cholesterol levels below 240 mg per deciliter (mean, 209) and LDL cholesterol levels of 115 to 174 mg per deciliter (mean, 139); 3583 men and 576 women.
What was CARE's main result?
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).
How much did LDL cholesterol change in CARE?
LDL cholesterol levels of 115 to 174 mg per deciliter (mean, 139) at baseline
Related trials
- WOSCOPS (1995)In middle-aged men with moderate hypercholesterolemia and no prior MI, pravastatin significantly reduced coronary events and cardiovascular death without increasing noncardiovascular deaths.
- 4S (1994)In patients with coronary heart disease and elevated cholesterol, simvastatin reduced the risk of death and major coronary events compared with placebo over about 5.4 years.
- AFCAPS/TexCAPS (1998)In men and women with average cholesterol but low HDL-C and no known heart disease, lovastatin substantially lowered the risk of a first major coronary event.
- LIPID (1998)In patients with coronary heart disease and a broad range of cholesterol levels, pravastatin reduced death from coronary heart disease, overall mortality, and other cardiovascular events compared with placebo.
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