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Medical Letter on the CDC & FDA

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Cardiovascular Disease



FDA approves Lipitor to lower risk of heart attacks



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 & FDA (2004-09-05)

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