Lipitor® Tablets has been approved by the USFDA for the following 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.
A product of Pfizer (NYSE: PFE) - Lipitor® (previously approved to reduce cardiovascular events in patients without heart disease) - is the first cholesterol-lowering medication approved by the USFDA for the reduction of the risk of hospitalization for heart failure.
According to Dr. John C. LaRosa, president and professor of medicine at the State University of New York Downstate Medical Center in Brooklyn, N.Y. and lead investigator for the Treating to New Targets (TNT) trial:
"These new indications are important since many patients who have heart disease remain at risk for another cardiovascular event, and now these indications broaden the means to reduce their risk. The significant reduction in cardiovascular events seen in the TNT trial can now be applied to everyday practice and benefit people with heart disease in the United States."
The said FDA approval was based on the positive results from the landmark TNT trial (the longest and largest study of Lipitor 80 mg efficacy and safety) and supported by findings from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial.
Read the full report.
.jpg)
Comment Preview