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Bristol-Myers Squibb (BMY) And Pfizer (PFE) Present Observational Real-World Data Analysis On The Effectiveness And Safety Of Eliquis (Apixaban) Compared To Warfarin In Select High-Risk Patients With Non-Valvular Atrial Fibrillation

8/28/2017 11:49:31 AM

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- In an analysis of four U.S. insurance databases, Eliquis was associated with a lower risk of stroke/systemic embolism (SE) and lower rates of major bleeding in select high-risk non-valvular atrial fibrillation (NVAF) patient subgroups

PRINCETON, N.J. & NEW YORK--()--Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced results from an analysis of real-world data pooled from four large U.S. insurance claims databases. 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. The analysis will be presented today at ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain.

In this real-world analysis, 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. It is important to note that Eliquis increases the risk of bleeding and can cause serious, potentially fatal, bleeding.

“Stroke events continue to be a major concern for patients with NVAF as well as their healthcare providers, and these findings supplement Eliquis clinical trial data,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “This real-world data analysis helps provide insight into how Eliquis fares in patient populations and settings that clinicians commonly see in practice.”

This observational cohort analysis adds to the body of evidence for Eliquis, which notably includes the Phase 3 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 causalityii,iii (please see full methodology and additional limitations, as well as indications and important safety information for Eliquis, later in this press release).

“The global need to address stroke related to NVAF has never been greater, and the Bristol-Myers Squibb-Pfizer Alliance is intentionally focused on helping to reduce the risk of stroke for as many patients as possible among a broad range of patient type scenarios,” said Rory O’Connor, M.D., Chief Medical Officer, Pfizer Internal Medicine. “We believe real-world data analyses via the ACROPOLIS program are helping to advance deeper levels of insight into how different patient demographics, comorbidities and disease severity factor into how Eliquis may impact patient outcomes.”

In this analysis, Eliquis was associated with lower risk of stroke/SE and lower rates of major bleeding across these risk factors compared to warfarin (38,470 propensity score matched pairs), with a mean follow-up of six months.

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