The drug has been approved 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.
The approval is based on results from two trials. In one of the studies, patients taking Lipitor 80mg had a significant 22% reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10mg. In addition, patients treated with Lipitor 80mg had a significant 26% reduction in the risk of hospitalization for heart failure.
According to Pfizer, Lipitor is the most prescribed cholesterol-lowering therapy in the world.