ACC: FDA Widens Lipitor Approval to Include Heart Disease Patients

 

March 23, 2007

Pfizer says the FDA has approved the company’s 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 — making Lipitor the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalization for heart failure.

The expanded indications mean the drug is available 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. Lipitor was previously 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.