ELIQUIS (apixaban) was Superior to Warfarin for the Reduction of Stroke or Systemic Embolism with Significantly Less Major Bleeding in Patients with Atrial Fibrillation in Phase 3 ARISTOTLE Trial
8 September 2011, New Delhi-- Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) announced on Aug 28, 2011 the main results of the Phase 3 clinical trial ARISTOTLE (Apixaban for Reduction In Stroke and Other Thromboembolic Events in Atrial Fibrillation), which evaluated ELIQUIS® (apixaban) compared to warfarin for the prevention of stroke or systemic embolism in 18,201 patients with atrial fibrillation and at least one risk factor for stroke. In the ARISTOTLE trial, ELIQUIS as compared with warfarin significantly reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent, and mortality by 11 percent. Results were presented on Aug 28, 2011 during the Hot Line session at the European Society of Cardiology Congress in Paris, France, and published in The New England Journal of Medicine.
Conducted in 1,034 centers in 39 countries, the study was coordinated by the Duke Clinical Research Institute, Durham, N.C., and Uppsala Clinical Research Institute, Uppsala, Sweden.
“We know high-risk patients with Atrial Fibrillation continue to have events, and we know oral anticoagulant is effective. The results from ARISTOTLE trial demonstrated that apixaban as compared with warfarin significantly reduces the risk of stroke, major bleeding and mortality” said Mr. Pheroze Khan, Managing Director, Bristol Myers Squibb India.
“The risk for stroke in patients with atrial fibrillation is a major public health concern in an aging population,” said Dr. Christopher B. Granger, professor of medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C., and lead investigator of the study. “We are therefore encouraged by the outcome of the ARISTOTLE trial, which showed that apixaban, as compared with warfarin, significantly reduced the risk of stroke or systemic embolism, major bleeding, and mortality.”
ELIQUIS, a new oral direct Factor Xa inhibitor, is part of a class of agents being studied for their potential to prevent and treat blood clots.
Atrial fibrillation (AF) the most common sustained cardiac rhythm disorder is associated with mortality and morbidity from stroke and thromboembolism not only in the western world but in India as well. In patients with AF the risk for thromboembolism is 17-18% per year and therefore published guidelines for stroke prevention in AF patients recommend treatment with oral anticoagulants. Importantly, the burden of higher AF patient population and increased presence of other risk factors causing stroke viz. hypertension, diabetes, ischemic heart disease and advanced age in India is higher as compared to the western world. In addition to disease burden of AF, inadequate screening, evaluation, and management strategies for stroke prevention in AF are some of the practical issues in India. On the other hand the current standard of care like warfarin which is used to prevent stroke in such patients is more than 50 years old and require specified therapeutic (INR) monitoring because of bleeding risk. Apixaban thus has potential to change the treatment paradigm for Atrial fibrillation patients.
