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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

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