Lipitor given the green light for more heart risk patients

Mar 8 2007

The Food and Drug Administration (FDA) in the U.S. has given approval for the best seller drug Lipitor to be used in five new categories.

Lipitor (atorvastatin) is a cholesterol-lowering medication made by the drug giant Pfizer, and is now recommended for use in patients at high risk for cardiovascular conditions because of prior MI, heart surgery, or chest pain with evidence of atherosclerosis and to reduce the risk of non-fatal heart attacks and strokes.

The expanded label for the world's top-selling prescription drug will also now include its approval for use in reducing the risks of hospitalization for heart failure.

Lipitor is the first cholesterol-lowering drug to win approval for reducing such risks.

The approval comes as a result of a five-year study, ' Treating to New Targets (TNT)' , involving 10,000 patients with heart disease and elevated LDL levels which compared Lipitor at its lowest and highest doses.

It was found that patients taking 80 mg of Lipitor had a significant 22% reduction in the risk of major cardiovascular events compared with patients taking 10 mg.

It was also found that the patients on the higher dose of Lipitor had a significant 26% reduction in the risk of hospitalization for heart failure.

The findings are supported by those from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial.

Data from the two trials were used to gain the label expansion for the higher dose of Lipitor, sales of which last year reached around $13 billion.