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Pfizer Receives FDA Approval For Lipitor® Tablets To Reduce Heart And Stroke Risk


NEW YORK -- Pfizer announces 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.”


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