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FDA approves Lipitor for high blood lipids

April 1, 1997

FDA approves Lipitor for high blood lipids

The U.S. Food and Drug Administration has cleared Lipitor (atorvastatin calcium) for sale in the United States. It is the only drug in its class specifically indicated for lowering both elevated LDL-cholesterol and triglycerides.

The statin, or HMG-CoA reductase inhibitor, is meant to be used as an adjunct to diet. In studies it significantly reduced elevated LDL-cholesterol by about 40% to 60% and triglycerides by about 20% to 40% across the dose range of 10 mg to 80 mg administered once daily. The starting daily single dose is 10 mg taken with or without food. The majority of patients achieve their total- and LDL-cholesterol targets with the starting dose.

Lipitor compared favorably to other statins such as Zocor, Pravachol, and Mevacor in clinical trials.