Pfizer Inc. on Wednesday said U.S. regulators have allowed the company to advertise that Lipitor (atorvastatin) cuts the risk of myocardial infarction.
The New York-based drugmaker said the decision by the U.S. Food and Drug Administration was based on the findings of a clinical trial in which patients taking the lowest 10-milligram dose of Lipitor had a 36% lower risk of MI than those taking placebos.
The administration based its approval on a study which showed 10mg of Lipitor reduced the relative risk of heart attack by 36 percent compared to placebo. Since benefits were seen early, the trial was ended nearly two years ahead of schedule. Another Lipitor study that ended two years ahead of schedule showed that patients with diabetes who took Lipitor had 48 percent fewer strokes than those who received placebo, and had significantly fewer fatal and non-fatal heart attacks and required fewer surgical procedures.
Pfizer plans to submit additional studies to the FDA for inclusion in the product’s prescribing information.
Lipitor is the world’s top-selling medicine, with global annual sales of $10 billion.
Lipitor is used for those who have abnormally High cholesterol levels. When taken together with a low-fat diet, this medicine can effectively reduce LDL cholesterol, commonly referred to as the “bad” cholesterol, triglyceride levels, and total cholesterol, while increasing the HDL, or “good” cholesterol.
Revision date: July 6, 2011
Last revised: by Janet A. Staessen, MD, PhD