PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced findings from a real-world data analysis of the U.S. Medicare database comparing the risk of stroke or systemic embolism and rate of major bleeding among patients with non-valvular atrial fibrillation who were treated with direct oral anticoagulants versus warfarin. In the analysis, titled Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Compared to Warfarin among Non-Valvular Atrial Fibrillation Patients in the U.S. Medicare Population, Eliquis® (apixaban) was associated with a significantly lower risk of stroke or systemic embolism and lower rate of major bleeding compared to warfarin.i These data, which supplement results from randomized trials, are being presented at the American College of Cardiology’s (ACC) 66th Annual Scientific Session in Washington, D.C.
In this observational analysis, medical and pharmacy claims were evaluated from the U.S. Medicare fee-for-service database of non-valvular atrial fibrillation patients age 65 and older who were newly prescribed oral anticoagulation therapy between January 1, 2013, and December 31, 2014 (n=186,132, following inclusion and exclusion criteria). The analysis included 41,606 patients treated with Eliquis or warfarin (20,803 patients each in the Eliquis and warfarin cohorts), balanced according to select demographic and clinical characteristics. The matched Eliquis-warfarin cohorts, followed for a mean of 5.7 and 6.5 months, respectively, had a mean age of 78 years, a CHA2DS2-VASc score of 4.6 and 4.7, respectively, and a HAS-BLED score of 3.3. CHA2DS2-VASc score is a method for estimating stroke risk in patients with atrial fibrillation, and HAS-BLED score helps to estimate risk of major bleeding in patients with atrial fibrillation. Real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. Observational real-world studies can only evaluate association and not causality.ii,iii Please see full methodology and additional limitations below.
