FDA Approves Pfizer’s Lipitor® to Reduce Risk of Strokes and Heart Attacks in Patients with Diabetes

Also Approved to Reduce Stroke Risk in People with Several Other Risk Factors for Heart Disease.

NEW YORK, September 27 -- Pfizer Inc announced today that the U.S. Food and Drug Administration has approved its cholesterol-lowering medicine Lipitor® (atorvastatin calcium) to reduce the risk of stroke and heart attack in people with type 2 diabetes without evidence of heart disease but with other risk factors. Lipitor also received approval to reduce the risk of stroke in people without evidence of heart disease but 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 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.

More than 18 million Americans suffer from diabetes, which is a leading risk factor for cardiovascular disease. The majority of people with diabetes—roughly 65 percent—will suffer a heart attack or stroke, a rate that is up to four times higher than in adults without diabetes. According to the American Diabetes Association recommended treatment guidelines, adults with type 2 diabetes should be considered for statin therapy regardless of their LDL levels.

“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, Ph.D., 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.”

Since the introduction of Lipitor eight years ago, its safety and efficacy have been supported through an extensive clinical trial program with more than 400 ongoing and completed trials involving more than 80,000 patients, Lipitor is the most prescribed cholesterol-lowering therapy in the world with over 100 million patient years of experience.

Lipitor® (atorvastatin calcium) is a prescription drug. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age 55 or older, low HDL cholesterol or smoking, to reduce the risk of heart attack or stroke and, along with a low-fat diet, to lower cholesterol.

Lipitor is used in patients with type 2 diabetes and one other risk factor such as high blood pressure, smoking, or other complications of diabetes, including eye disease and protein in urine, to reduce the risk of stroke and heart attack.

Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may become pregnant.

If you take Lipitor, tell your doctor if you feel any unusual muscle pain or weakness. This could be a sign of serious muscle side effects. Tell you doctor about all medicines you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before and during drug treatment and may adjust your dose. The most commonly side effects are gas, constipation, stomach pain, and heartburn. They tend to be mild and often go away.

For additional important information about Lipitor, visit www.lipitor.com or 1-888-LIPITOR.

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