About Atrial Fibrillation
Atrial fibrillation is the most common sustained cardiac arrhythmia. It is estimated that more than 5 million Americans and 6 million individuals in the European Union have AF. The lifetime risk of atrial fibrillation is estimated to be approximately one in four for individuals 40 years of age or older. The underlying threat of atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, 15 percent of all strokes in the U.S. are attributable to atrial fibrillation.
About ARISTOTLE and AVERROES
The ELIQUIS stroke prevention in atrial fibrillation clinical trial program was designed to comprehensively evaluate ELIQUIS in approximately 24,000 patients with atrial fibrillation requiring stroke prevention, including patients who are expected or demonstrated to be unsuitable for vitamin K antagonist therapy.
ARISTOTLE, a double-blind, multicenter, head-to-head Phase 3 trial, randomized more than 18,000 patients with atrial fibrillation from over 1,000 centers in about 40 countries. Patients were randomized to receive either ELIQUIS 5 mg twice daily (2.5 mg twice daily in selected patients) or dose-adjusted warfarin (titrated to a target INR range of 2.0 to 3.0). The key study outcomes were prespecified in a hierarchical manner that sequentially tested ELIQUIS versus warfarin for noninferiority on the composite endpoint of stroke or systemic embolism; superiority on the composite endpoint of stroke or systemic embolism; superiority on major bleeding; and superiority on all-cause death.
The AVERROES study evaluated ELIQUIS compared to aspirin in 5,599 patients with atrial fibrillation at risk for stroke who were demonstrated or expected to be unsuitable for vitamin K antagonist therapy.
ELIQUIS is the approved trade name for apixaban in Europe and the proposed trade name in the United States. ELIQUIS is not approved in any country for the prevention of stroke in patients with atrial fibrillation. Bristol-Myers Squibb and Pfizer recently announced the first regulatory approval for ELIQUIS in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Apixaban is not currently approved in the United States.
ELIQUIS is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials, including ARISTOTLE and AVERROES.
In addition to stroke prevention in patients with atrial fibrillation and the prevention of VTE in patients who have undergone total hip or total knee replacement surgery, ELIQUIS is being investigated in Phase 3 trials for the treatment of VTE and the prevention of VTE in hospitalized acutely ill medical patients.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.