Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced the publication of the full results of the AVERROES study of apixaban in The New England Journal of Medicine. Conducted in 36 countries, the study was coordinated by the Population Health Research Institute (PHRI) at McMaster University and at Hamilton Health Sciences in Canada. The study demonstrated that, for patients with atrial fibrillation (AF) who were expected or demonstrated to be unsuitable for a vitamin K antagonist (VKA) therapy such as warfarin, apixaban was statistically superior to aspirin in reducing the composite of stroke or systemic embolism, without a significant increase in major bleeding, fatal bleeding or intracranial bleeding. Importantly, there were no significant differences in the risk of hemorrhagic stroke between apixaban and aspirin. The study results also showed that apixaban demonstrated superiority for its secondary efficacy endpoint in reducing the composite of stroke, systemic embolism, myocardial infarction or vascular death for patients with AF when compared with aspirin.
Aspirin has remained a treatment option in patients for whom warfarin or other VKAs have been demonstrated or predicted to carry unacceptable bleeding risks. This study was designed to address whether a more favorable option might exist for this patient population.
Atrial fibrillation is the most common sustained cardiac arrhythmia, affecting approximately 5.1 million people in the U.S. and more than 6 million in Europe. 1, 2 The lifetime risk of AF is estimated to be approximately one in four for individuals 40 years of age or older.3 The underlying threat of AF is the increased risk of stroke, which is five times higher in people with AF than those without AF. In fact, 15 percent of all strokes are attributable to AF in the U.S.4
Apixaban is an investigational, oral, highly selective Factor Xa inhibitor, part of a class of agents being studied for their potential to prevent and treat blood clots in the veins and arteries. Preliminary results of AVERROES were first presented in August 2010, at the European Society of Cardiology annual meeting in Stockholm, Sweden. Full results will also be presented today at the International Stroke Conference in Los Angeles.
“The risk of stroke or systemic embolism is of great concern for patients with atrial fibrillation, especially because AF-related strokes can be particularly devastating,” said Stuart Connolly, MD, professor of medicine at McMaster University in Hamilton, Canada, and lead investigator of the study. “We are encouraged by the AVERROES data, which demonstrated that apixaban is more effective than aspirin without a significantly increased risk of major bleeding. Given the significant number of patients who are not eligible for treatment with vitamin K antagonists, it is especially important to have potential new treatment options that are both safe and effective.”
Source: Bristol-Myers Squibb
Pfizer Inc