The FDA's decision was based on the findings of the Collaborative Atorvastatin Diabetes Study (CARDS), 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 percent fewer strokes than those on placebo. The CARDS trial was stopped nearly two years earlier than planned by the study's Steering Committee 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 The Anglo- Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOT-LLA) another landmark trial which was also halted nearly two years earlier than planned. The trial found that Lipitor reduced the relative risk of stroke by 26% percent 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 David Waters, M.D., F.A.C.C., Chief of Cardiology, San Francisco General Hospital, San Francisco, CA. "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."

The American Heart Association (AHA) estimates that 700,000 Americans -- or one person every 45 seconds -- will experience a stroke in 2005. Stroke is more prevalent in adults age 65 and older, and the incidence of stroke continues to rise as age increases. According to the AHA, stroke is a leading cause of major disability in the United States. Direct (medical) and indirect (disability) costs related to stroke are anticipated at $57 billion in 2005.

The 2004 update to guidelines issued by the National Cholesterol Education Program confirms the added benefit of prescribing cholesterol-lowering medication like Lipitor, along with diet modification and exercise, to patients at risk for cardiovascular disease.