Pravastatin for patients with average cholesterol levels - Tips from Other Journals

Author: Linz Audain
Date: Feb 15, 1997

Lowering the cholesterol levels of patients with elevated low-density lipoprotein (LDL) cholesterol levels decreases the risk of coronary heart disease. What is less clear is the extent to which a decrease in LDL cholesterol in patients with average levels will decrease the occurrence of coronary events. Sacks and associates conducted a five-year, double-blind study to determine the effect of lowering LDL cholesterol levels in patients with average cholesterol levels and coronary heart disease.

A total of 4,159 patients were randomized to two treatment groups. All of the patients had plasma LDL cholesterol levels less than 240 mg per dL (6.20 mmol per L) and had had an acute myocardial infarction within 20 months of randomization. Of these patients, 2,081 received pravastatin, 40 mg once daily, and 2,078 received placebo. Once randomized, all of the patients were examined quarterly. Patients continued to take all of their regular medications while participating in the trial. During the trial, any patient with an LDL cholesterol level greater than 175 mg per dL (4.55 mmol per L) was given diet counseling. If diet counseling was ineffective in decreasing the patient's LDL cholesterol, the patient was given cholestyramine. If both treatments failed, the patient was sent to his or her physician for further treatment.

The outcome measures of the study included death or a symptomatic myocardial infarction. The frequency of the primary end point was 13.2 percent of patients in the placebo group and 10.2 percent of patients in the pravastatin group. This difference was statistically significant. In addition, a number of indexes of coronary morbidity, such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, unstable angina and stroke, were reduced in the pravastatin group. Pravastatin therapy lowered the average LDL cholesterol level of patients by 32 percent, maintained average LDL cholesterol levels at 97 to 98 mg per dL (2.50 to 2.55 mmol per L) during the five-year follow-up and increased the average HDL cholesterol level by 5 percent.

When compared with placebo, pravastatin was more effective in decreasing major coronary events in women and in patients with higher baseline LDL cholesterol levels. Patients with baseline LDL cholesterol levels above 150 mg per dL (3.90 mmol per L) had a 35 percent reduction in major coronary events, compared with a 26 percent reduction in patients with baseline levels of 125 to 150 mg per dL (3.25 to 3.90 mmol per L) and a 3 percent increase in patients with baseline levels below 125 mg per dL (3.25 mmol per L). The mortality rate from noncardiovascular causes did not differ significantly between the two groups.

The authors conclude that cholesterol-lowering therapy can decrease coronary morbidity and mortality in patients who have coronary heart disease, a history of myocardial infarction and average LDL cholesterol levels.

Sacks FM, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med 1996;335:1001-9.

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