03.08.07
Pfizer has received FDA approval for Lipitor Tablets for five new indications: 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, the TNT trial and the Aggressive Lipid Lowering (IDEAL) trial. The five-year TNT study, evaluating efficacy and safety of Lipitor 80 mg, involved 10,000 patients with both heart disease and elevated LDL levels. Results showed a 22% 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% reduction in the risk of hospitalization for heart failure.
While there were more serious adverse events and discontinuations with Lipitor 80 mg compared with Lipitor 10 mg, there was no difference in the overall frequency of treatment-related adverse events.
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, the TNT trial and the Aggressive Lipid Lowering (IDEAL) trial. The five-year TNT study, evaluating efficacy and safety of Lipitor 80 mg, involved 10,000 patients with both heart disease and elevated LDL levels. Results showed a 22% 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% reduction in the risk of hospitalization for heart failure.
While there were more serious adverse events and discontinuations with Lipitor 80 mg compared with Lipitor 10 mg, there was no difference in the overall frequency of treatment-related adverse events.