Magazine article Drug Topics

Cholesterol Drug Cleared for Those with No Heart Disease

Magazine article Drug Topics

Cholesterol Drug Cleared for Those with No Heart Disease

Article excerpt

Pravastatin (Pravachol, Bristol Myers Squibb) has been approved by the Food & Drug Administration to reduce the risk of heart attack in patients with high cholesterol levels who have no history of cardiovascular disease, making it the first of its class to carry a primary prevention indication.

The new labeling is based on the results of the West of Scotland (WOS) Study (N Engl J Med 1995;333:1301-7), a double-blind study of 6,595 men between the ages of 45 and 64 with elevated cholesterol levels (median 272+/23 mg/dL) and no history of myocardial infarction. In the study, pravastatin reduced the risk of heart attack and death by 31%o/oe The risk of death from all causes was reduced 22%. There was also a significant decrease in the number of coronary events. Cholesterol levels were reduced by 20%, LDL cholesterol dropped 26%, and triglycerides fell 12%. HDL, the socalled good cholesterol, increased 5%.

The new labeling states that, in hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin is indicated to: reduce the risk of myocardial infarction

reduce the risk of undergoing myocardial revascularization procedures reduce the risk of cardiovascular mortality with no increase in death from noncardiovascular causes

As Mark Malesker, Pharm.D., clinical pharmacy coordinator, Immanuel Medical Center, and assistant professor of pharmacy practice at Creighton University, Omaha, explained, WOS was the first study to actually show the benefits of primary prevention with an HMG-CoA reductase inhibitor (or statin).

In the 1980s, Malesker explained, data showed that primary prevention decreased cardiac mortality over time but that noncardiac mortality either did not change or was increased. "The WOS study showed a favorable profile for all types of mortality, not just cardiac endpoints," he said. He emphasized that WOS is the first primary prevention study to show the endpoints of nonfatal Ml, death from cardiac disease, death from noncardiac disease, death from all causes, and frequency of events. Merck's simvastatin (Zocor) is also indicated by the FDA to reduce the risk of mortality, to reduce the risk of nonfatal myocardial infarctions, and to reduce the risk of needing myocardial revascularization procedures. But simvastatin's indication is limited to patients with coronary heart disease and hypercholesterolemia. …

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