News | March 21, 2007

FDA Widens Lipitor Approval to Include Heart Disease Patients

March 22, 2007 — Pfizer says the FDA has approved the company’s Lipitor (atorvastatin calcium) Tablets 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 — making Lipitor the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalization for heart failure.

The expanded indications mean the drug is available 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. Lipitor was previously approved to reduce cardiovascular events in patients without heart disease.

"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," said 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. "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 approval is based on results from the landmark TNT trial and supported by findings from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial. The results of these two trials were important enough to be referenced in updated treatment guidelines issued jointly by the American Heart Association and the American College of Cardiology in 2006.

The five-year TNT study involved 10,000 patients with both heart disease and elevated LDL levels. It is the longest and largest study of Lipitor 80 mg efficacy and safety.

For more information visit www.lipitor.com.

Related Content

Quantum Genomics Enrolls First Patient in QUORUM Phase IIb Study of Firibastat
News | Pharmaceuticals | June 14, 2019
Quantum Genomics announced the enrollment of the first patient in its QUORUM Phase IIb study of its lead clinical...
FDA Grants Priority Review for Vascepa sNDA
News | Pharmaceuticals | May 29, 2019
Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has...
Vascepa Markedly Reduces First, Repeat and Total Cardiovascular Events
News | Pharmaceuticals | March 29, 2019
Taking a high dose of icosapent ethyl significantly reduces the occurrence of first, subsequent and total ischemic...
Bempedoic Acid Combination Tablet Significantly Lowers LDL-Cholesterol

Image courtesy of Esperion

News | Pharmaceuticals | March 25, 2019
Phase 3 results from Study 2, also known as CLEAR WISDOM, of bempedoic acid were recently presented at the American...
Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall
News | Pharmaceuticals | January 10, 2019
January 10, 2019 — Aurobindo Pharma USA Inc.
Mylan Expands Nationwide Recall of Valsartan Blood Pressure Medication
News | Pharmaceuticals | December 11, 2018
December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all
Farxiga Reduces Heart Failure Hospitalization, Cardiovascular Death for Type 2 Diabetes
News | Pharmaceuticals | November 15, 2018
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for...
Vascepa and Statins Significantly Reduce Cardiovascular Events in the REDUCE-IT trial. #AHA #AHA18 #AHA2018
News | Pharmaceuticals | November 13, 2018
A study in the current edition of the New England Journal of Medicine shows that a particular treatment significantly...
Evolocumab Benefits High-Risk Patients With Established Cardiovascular and Chronic Kidney Disease
News | Pharmaceuticals | October 31, 2018
Amgen announced a new Repatha cardiovascular outcomes study (FOURIER) analysis evaluating the effects of Repatha (...
Overlay Init