Lipitor cleared for reducing stroke risk in diabetics
Pfizer's Lipitor (atorvastatin) gained FDA approvals for reducing the risk of stroke and heart attack in people with type 2 diabetes and in those with other risk factors.
The approval to prescribe Lipitor in patients with type 2 diabetes is for those who present no evidence of heart disease but who have other risk factors, Pfizer said.
So too for the second indication, the statin can be used to lower the chance of stroke in patients without evidence of heart disease but with multiple risk factors, such as high cholesterol, high blood pressure, smoking or obesity.
The regulatory decision was based on findings from two landmark studies, one of which showed patients on Lipitor had a near 50-percent reduction in strokes over those with placebo, according to the drug maker. The other showed that Lipitor lowered relative risk of stroke by 26 percent vs. placebo. Cohorts in both studies included patients with diabetes.
More than 18 million Americans have diabetes. Pfizer said statistics show about 65 percent will experience a heart attack or stroke, a rate that is up to four times greater than adults without the disease.
Lipitor was the top-prescribed drug in 2004, according to IMS Health, accounting for some 75 million prescriptions. The drug had $2.9 billion of worldwide revenue in the second quarter, Pfizer said.