June 22nd, 2011

Apixaban (Eliquis) Meets Primary Endpoint in ARISTOTLE

Pfizer and Bristol-Myers Squibb said that their new oral direct Factor Xa drug apixaban, which will be marketed under the brand name of Eliquis, had met the primary endpoint of the ARISTOTLE study.

The Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE) study was designed to compare the factor Xa inhibitor apixaban with warfarin for the prevention of stroke and systemic embolism in atrial fibrillation (AF) patients with additional risk factors for stroke. The primary outcome was the time to first occurrence of either stroke or systemic embolism. According to the companies, apixaban met the criteria for noninferiority to warfarin in the trial.

The companies also said that apixaban had met the trial’s secondary endpoint, demonstrating superiority to warfarin for efficacy and major bleeding, defined as the combined rate of ischemic stroke, hemorrhagic stroke, systemic embolism, and  all cause death.

Detailed results of ARISTOTLE will be presented at the European Society of Cardiology Congress 2011 in Paris on August 28.

Comments are closed.