FDA Approves Pfizer's Lipitor(R) to Lower Risk of Heart Attacks

Market Wire, August, 2004

Pfizer Inc (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved its cholesterol-lowering therapy LIPITOR® (atorvastatin calcium) for the prevention of cardiovascular disease by reducing heart attack risk in people with normal to mildly elevated levels of cholesterol but with other risk factors for heart disease.

The FDA's decision was based on the findings of a landmark clinical trial, known as the Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOT-LLA), which found that LIPITOR, at its lowest dose of 10 mg, reduced the relative risk of heart attack by 36 percent compared to placebo. Because of the significant benefits seen with LIPITOR early in the trial, ASCOT-LLA was halted approximately two years ahead of schedule. The safety profile of the group treated with LIPITOR was comparable to that of the group treated with placebo. The trial involved more than 10,300 people with normal or borderline cholesterol and no prior history of heart disease, but with high blood pressure and at least three other known risk factors for heart disease, such as family history, age over 55, smoking, diabetes and obesity.

"Despite fairly normal cholesterol levels, patients with multiple risk factors face a greater threat of heart attack," said David Waters, M.D., F.A.C.C., Chief of Cardiology at San Francisco General Hospital, CA. "Adding LIPITOR to their treatment regimen, as the data demonstrate, reduces that threat dramatically. It's becoming increasingly clear that LIPITOR provides cardiovascular benefits that go well beyond lowering cholesterol."

Updated guidelines recently issued by the National Cholesterol Education Program confirm the added benefit of prescribing cholesterol-lowering medication like LIPITOR, along with diet and exercise, to patients at risk for cardiovascular disease.

Mike Cummo, a 55-year-old design consultant from Rockville Centre, NY, has a family history of heart disease and is taking medication to manage his blood pressure. "Even though my blood pressure is under control and my cholesterol isn't high, I'm still worried about my increased risk of having a heart attack," he said. "I want to watch my grandson grow up so I'm going to ask my doctor about taking LIPITOR."

The FDA also approved LIPITOR to reduce the risk of angina (chest pain) and to reduce revascularization procedures, such as balloon angioplasty, that help open blocked arteries.

CVD Impact

Every year, more than 865,000 Americans suffer a heart attack. There are 7.8 million people in the U.S. who are heart attack survivors. High blood pressure and elevated cholesterol are the leading risk factors for heart disease but other factors compound the risk, including family history of heart disease, age over 55, smoking, diabetes, obesity and lack of exercise. Direct (medical costs) and indirect (lost productivity) costs related to coronary heart disease are expected to exceed $133 billion in 2004.

"Today's FDA approval of LIPITOR's additional uses further supports the growing body of evidence showing that LIPITOR provides significant cardiovascular benefits in a broad range of patients beyond its excellent efficacy in lowering cholesterol," said Gary Palmer, M.D., Vice President of Pfizer Cardiovascular's Medical Group.

LIPITOR is the leading cholesterol-lowering therapy in the world with more than 76 million patient years of experience. Since the introduction of LIPITOR seven years ago, its safety and effectiveness have been supported through the Atorvastatin Landmark Program(TM), an extensive clinical program with more than 400 ongoing and completed trials involving more than 80,000 patients.

About LIPITOR

LIPITOR® (atorvastatin calcium) is a prescription drug used with diet to lower cholesterol and to reduce the risk of heart attacks. LIPITOR is not for everyone, including those with liver disease or possible liver problems, women who are nursing, pregnant, or may become pregnant.

If you take LIPITOR, tell your doctor about any unusual muscle pain or weakness. This could be a sign of serious muscle side effects. It is important to tell your doctor about any medications you are currently taking to avoid possible serious drug interactions. Your doctor should do simple blood tests to monitor liver function before and during drug treatment and may adjust your dose. The most commonly reported side effects are gas, constipation, stomach pain, and indigestion. They are usually mild and tend to go away.

For full prescribing information, please visit www.lipitor.com or call 1-888-LIPITOR.

Contact: Samina Bari (212) 733-5273