FDA grants extended approval of Pfizer’s Lipitor

The drug will now be available to patients with type 2 diabetes who do not exhibit evidence of heart disease but who may show one other risk factors for the condition.

Lipitor also received approval to reduce the risk of stroke in people with multiple risk factors other than diabetes. Common risk factors for heart disease include high cholesterol, high blood pressure, family history, age over 55, smoking, diabetes and obesity.

The FDA’s decision was based on the findings a landmark 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, that showed patients on Lipitor experienced nearly 50% fewer strokes than those on placebo.

The trial was stopped nearly two years earlier than planned because of the strong benefits among patients who took Lipitor.

The additional approval of Lipitor to reduce the risk of stroke in patients with multiple risk factors reflects findings from another trial that found Lipitor reduced the relative risk of stroke by 26% compared to placebo. The study involved more than 10,300 people with normal or borderline cholesterol and no prior history of heart disease, but with controlled high blood pressure and at least three other risk factors for heart disease, such as family history, age over 55, smoking, diabetes and obesity.

“Patients with multiple risk factors, including diabetes, face a greater threat of heart attack and stroke, so reducing their risk is critical,” said Dr David Waters, chief of cardiology, San Francisco General Hospital. “The idea that we can reduce the risk of heart attack and stroke even in this high-risk population with a drug like Lipitor is important.”