FDA Approves Expanded Indications for Atorvastatin

[Admin]

March 7, 2007 (New York, NY) – The Food and Drug Administration (FDA) has approved the expanded use of atorvastatin (Lipitor, Pfizer) to include patients at high risk for cardiovascular conditions because of prior MI, heart surgery, or chest pain with evidence of atherosclerosis.

The FDA approved atorvastatin for reducing the risk of nonfatal MI, reducing the risk of fatal and nonfatal strokes, for use in certain types of heart surgery, for reductions in the risk of hospitalization for heart failure, and to reduce chest pain in patients with heart disease. Atorvastatin is the first cholesterol-lowering drug to be approved for reducing the risk of hospitalization for heart failure.

The approval is based on results from the Treating to New Targets (TNT) trial and supported by findings from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial. The five-year TNT study, previously reported by heartwire, involved 10 000 patients with heart disease and elevated LDL levels. Those taking atorvastatin 80 mg had a significant 22% reduction in the risk of major cardiovascular events compared with patients taking atorvastatin 10 mg. In addition, patients treated with high-dose atorvastatin had a significant 26% reduction in the risk of hospitalization for heart failure.

Sales of atorvastatin in 2006 were $13 billion

Source: http://www.medscape.com/viewarticle/553290?src=mp