Cardiovascular Disease

FDA approves Lipitor to lower risk of heart attacks

Published in Medical Letter on the CDC and FDA, September 5th, 2004

Pfizer, Inc., reported the U.S. Food and Drug Administration (FDA) has approved its cholesterol-lowering therapy Lipitor (atorvastatin calcium) for the prevention of cardiovascular disease by reducing heart attack risk in people with normal-to-mildly elevated cholesterol levels who have other cardiovascular risk factors.

The FDA's decision was based on the findings of the ASCOT trial (Anglo-Scandinavian cardiac outcomes trial), which found that the lowest dose of Lipitor (10 mg) reduced the relative risk of heart attack by 36% compared to placebo. Because these significant benefits were seen so early, the trial was ended nearly 2 years ahead of schedule.

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Source: Medical Letter on the CDC and FDA (2004-09-05)

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