Lipitor Receives FDA Approval for Five New Indications in Patients With Heart Disease

Pfizer announced today that the U.S. Food and Drug Administration (FDA) has approved Lipitor® (atorvastatin calcium) Tablets to reduce the risk of nonfatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease. Lipitor is the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalization for heart failure.

This new approval expands the use of Lipitor to patients at high risk for cardiovascular events because of established heart disease such as prior heart attack, prior heart surgery, or chest pain with evidence of clogged arteries. Previously, Lipitor was approved to reduce cardiovascular events in patients without heart disease.

"These new indications are important since many patients who have heart disease remain at risk for another cardiovascular event, and now these indications broaden the means to reduce their risk," said Dr. John C. LaRosa, president and professor of medicine at the State University of New York Downstate Medical Center in Brooklyn, N.Y. and lead investigator for the Treating to New Targets (TNT) trial. "The significant reduction in cardiovascular events seen in the TNT trial can now be applied to everyday practice and benefit people with heart disease in the United States."

The approval is based on results from the landmark TNT trial and supported by findings from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial. The results of these two trials were important enough to be referenced in updated treatment guidelines issued jointly by the American Heart Association and the American College of Cardiology in 2006.

The five-year TNT study involved 10,000 patients with both heart disease and elevated LDL levels. It is the longest and largest study of Lipitor 80 mg efficacy and safety.

In this study, patients taking Lipitor 80 mg had a significant 22 percent reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10 mg. In addition, patients treated with Lipitor 80 mg had a significant 26 percent reduction in the risk of hospitalization for heart failure.

There were more serious adverse events and discontinuations due to adverse events with Lipitor 80 mg compared with Lipitor 10 mg. However, there was no difference in the overall frequency of treatment-related adverse events.

"Lipitor is the world's most extensively studied cholesterol-lowering medication, and is supported by a large clinical trial program that includes more than ten cardiovascular outcomes trials with over 50,000 patients across a broad spectrum of risk," said Dr. Michael Berelowitz, Pfizer senior vice president of global medical. "Lipitor is the only statin that offers a unique combination of proven significant cardiovascular event reductions, impressive average LDL lowering of 39 percent to 60 percent, and a well-established safety profile."

Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 133 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.

Atherosclerosis is a buildup of plaque including cholesterol and other substances in the walls of arteries. This buildup can cause arteries to become thick and hard (known as arteriosclerosis). It can also clog arteries, causing them to carry a reduced blood and oxygen supply to the organs. In the heart, this is manifested as coronary heart disease, a form of cardiovascular disease, and can result in a heart attack. In the brain, atherosclerosis can result in a stroke.

More than 15 million Americans have a history of coronary heart disease. This year, an estimated 300,000 Americans will have a recurrent heart attack. The prevalence of coronary heart disease also contributes to burdensome healthcare costs for patients as well as the nation's healthcare system. The American Heart Association expects direct and indirect costs of coronary heart disease to total nearly $152 billion in 2007.

Important US Prescribing Information

Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of heart attack, stroke, certain kinds of heart surgery, and chest pain.

Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.

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

When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

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.

Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.

For additional product information, visit http://www.lipitor.com/