Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that a large number of data presentations sponsored by the companies on ELIQUIS ® (apixaban) and the treatment of atrial fibrillation will be presented at the American Heart Association 2012 Scientific Sessions, November 3-7, 2012, in Los Angeles, California. Among the presentations are two prespecified subanalyses from the ARISTOTLE trial: a more detailed analysis of ISTH major bleeding with ELIQUIS versus warfarin and an evaluation of the safety and efficacy of ELIQUIS versus warfarin in patients with prior warfarin experience (warfarin-experienced compared with warfarin-naïve). Also being presented is a subanalysis from ARISTOTLE of the safety and efficacy of ELIQUIS versus warfarin in patients with prior coronary artery disease. The ARISTOTLE trial evaluated the efficacy and safety of ELIQUIS, an investigational compound for the prevention of stroke or systemic embolism, in patients with nonvalvular atrial fibrillation compared with warfarin.
Company-sponsored real-world data analyses providing relevant insights on management of atrial fibrillation and experience with warfarin, such as the correlation between bleeding and discontinuation, warfarin outcomes in the real-world compared to trial data, and early ischemic outcomes after warfarin initiation will also be presented.
Details on the ARISTOTLE data analyses and real-world data analyses at the congress are as follows:
|Session Details||Presentation Title||Lead Author|
|Monday November 5, 2012 10:45–11:00 PST Abstract Oral Session Room 403a||Apixaban in Patients with Atrial Fibrillation and Prior Coronary Artery Disease: Insights from the ARISTOTLE Trial||Maria Cecilia Bahit, MD, ECLA, Rosario, Argentina|
|Monday November 5, 2012 11:15-11:30 PST Abstract Oral Session Hall A-10||Apixaban versus Warfarin in Patients with Atrial Fibrillation in Relation to Prior Warfarin Use: Insights from the ARISTOTLE Trial||David A. Garcia, MD, University of New Mexico, Albuquerque, NM|
|Tuesday November 6, 2012 3:00–4:30 PST Abstract Poster Session Kentia Hall, Core 2, Poster Board: 2068||Reduction in Bleeding with Apixaban versus Warfarin is Consistent Across Subgroups and Locations: Insights from the ARISTOTLE Trial||Elaine M. Hylek, MD, Boston University, Boston, MA|
|OUTCOMES RESEARCH/REAL-WORLD DATA|
|Session Details||Presentation Title||Lead Author|
|Sunday November 4, 2012 9:30–11:00 PST Abstract Poster Session Kentia Hall, Core 2, Poster Board: 2117||Post-Discharge Stroke in Patients With Atrial Fibrillation: A Follow-Up Study in Major Cities of China||Bao Liu, Ph.D., School of Public Health, Fudan University, Shanghai, China|
|Sunday November 4, 2012 3:00–4:30 PST Abstract Poster Session Kentia Hall, Core 2, Poster Board: 2094||The Association Between Bleeding and Warfarin Discontinuation in Patients with Atrial Fibrillation||Xianying Pan, Bristol-Myers Squibb, Wallingford, CT|
|Monday November 5, 2012 9:30–11:00 PST Best of AHA Specialty Conferences||Exposure to Warfarin and the Risks of Stroke and Bleeding Events among Patients with Non-Valvular Atrial Fibrillation: Real-World vs. Clinical Trial||Alpesh Amin, MD, University of California, Irvine, Irvine, CA|
|Tuesday November 6, 2012 9:30–11:00 PST Abstract Poster Session Kentia Hall, Core 2, Poster Board: 2176||Impact of Bleeding on Length of Stay and Total Cost in Atrial Fibrillation Patients||Alpesh Amin, MD, University of California, Irvine, Irvine, CA|
|Tuesday November 6, 2012 9:30–11:00 PST Abstract Poster Session Kentia Hall, Core 2, Poster Board: 2177||Evaluation of Patient-Reported Disease Burden of Atrial Fibrillation||Liu Xianchen, Pfizer Inc., New York, NY|
|Tuesday November 6, 2012 9:30–11:00 PST Abstract Poster Session Kentia Hall, Core 2, Poster Board: 2175||Utilization Patterns of Anticoagulants in Non-Valvular Atrial Fibrillation after the entry of Novel Oral Anticoagulants in the United States||Melissa Hamilton, MPH, Bristol-Myers Squibb, Princeton, NJ|
|Wednesday November 7, 2012 9:15–9:30 PST Abstract Oral Session Room 511||Early Effects on Ischemic Strokes After Initiation of Warfarin in Patients With Atrial Fibrillation||Laurent Azoulay, Ph.D., M.Sc., Jewish General Hospital, Montreal, Canada|
|Wednesday November 7, 2012 9:30–11:30 PST Abstract Poster Session Kentia Hall, Core 2, Poster Board: 2051||Tolerability of Apixaban — Insights From A Meta-Analysis of Discontinuation Rates in Randomized Trials||Ria Kundu, MD, University of Toledo, Toledo, OH|
About Atrial FibrillationAtrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). It is estimated that more than 5.8 million Americans and 6 million individuals in Europe have atrial fibrillation. The lifetime risk of developing atrial fibrillation is estimated to be approximately 25 percent for individuals 40 years of age or older. One of the most serious medical concerns for individuals with 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 are attributable to atrial fibrillation in the U.S. Additionally, strokes due to atrial fibrillation are more burdensome than strokes due to other causes. Atrial fibrillation-related strokes are more severe than other strokes with an associated 30-day mortality of 24 percent and a 50 percent likelihood of death within one year in patients who are not treated with an antithrombotic.
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