blockbuster statin Lipitor received Food and Drug Administration approval to be used to cut the risk of strokes and heart attacks in diabetics who show risk factors for heart disease.
The cholesterol-lowering drug also was approved to reduce stroke risk in people without evidence of heart disease but with multiple risk factors other than diabetes, such as high blood pressure, family history, smoking and obesity.
The FDA's decision was based on the findings of a trial of more than 2,800 patients with Type 2 diabetes, near normal cholesterol and at least one other risk factor, such as high blood pressure or smoking. The study showed that the patients on Lipitor experienced nearly 50% fewer strokes than those on placebo.
"With this FDA approval, we're pleased that a broad range of patients, in addition to effectively lowering their cholesterol with Lipitor, will be able to derive the significant cardiovascular benefit of reducing their chances for suffering a stroke or heart attack," said Gregg Larson, Pfizer's U.S. medical vice president. "Even patients who have relatively low cholesterol levels, but who are at high risk due to multiple risk factors, have been shown to benefit from treatment with Lipitor."
According to Pfizer, about 65% of people with diabetes will suffer a heart attack or stroke, a rate that is up to four times higher than in adults without diabetes.