Real world data from among non-valvular atrial fibrillation (NVAF) patients shows Eliquis (apixaban) reduces risk of stroke.-BMS/Pfizer.

Bristol-Myers Squibb and Pfizer announced results from an analysis of real-world data showing that among non-valvular atrial fibrillation (NVAF) patients, Eliquis (apixaban) was associated with a lower risk of stroke/SE and lower rates of major bleeding compared to warfarin for the overall population as well as for each of the selected high-risk patient sub-populations. In this real-world analysis using data pooled from four large U.S. insurance claims databases, patients with NVAF receiving either Eliquis or other oral anticoagulants were identified through the U.S. Optum, MarketScan, PharMetrics, and Humana databases. The data was pooled after propensity score matching (PSM) was completed within each database. Select high-risk subgroups were stratified by age, CHA2DS2-VASc or HAS-BLED score, congestive heart failure (CHF), coronary artery disease (CAD), and peripheral artery disease (PAD). The CHA2DS2-VASc score is a method for estimating stroke risk in patients with non-valvular atrial fibrillation, and the HAS-BLED score helps to estimate risk of major bleeding in patients with NVAF.

In the subgroup analysis, based upon these variables, Eliquis was associated with lower risk of stroke/SE and lower rates of major bleeding compared to warfarin after adjustment for confounding factors. The analysis will be presented at ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain.

Comment: This observational cohort analysis adds to the body of evidence for Eliquis, which notably includes the Phase III ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) clinical trial in which the reduction in risk for stroke/SE, the primary efficacy endpoint for ARISTOTLE, was generally consistent for Eliquis compared with warfarin across various patient subgroups.i 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.