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Heart Disease Risk

FDA announces labeling changes on cholesterol drug Zocor

Published in Medical Letter on the CDC and FDA, May 11th, 2003

The U.S. Food and Drug Administration (FDA) has announced changes to the labeling for Zocor (simvastatin), based on the results of the Heart Protection Study (HPS).

The new labeling will reflect research showing that simvastatin is effective in reducing risks of fatal and nonfatal heart attacks, strokes, and in reducing the need for bypass surgery and angioplasty. FDA approved Zocor in 1991 to lower cholesterol.

The Heart Protection Study was a double-blind, placebo-controlled study conducted in 20,536 patients. Men and women with heart disease or at high risk because of diabetes, peripheral arterial disease, or a history of stroke or other...

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