FDA APPROVES LIPITOR FOR FIVE HEART DISEASE INDICATIONS

Pfizer announced that the FDA has approved Lipitor to reduce the risk of nonfatal heart attacks, fatal and nonfatal strokes, certain types of heart surgery, hospitalization for heart failure and chest pain, all in patients with heart disease.

Lipitor (atorvastatin calcium) is the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalization for heart failure, according to the company. Previously, Lipitor was approved to reduce cardiovascular events in patients without heart disease.

The approval is based on results from the TNT trial and supported by findings from the IDEAL trial. 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 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 26 percent reduction in the risk of hospitalization for heart failure, according to Pfizer.

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.