Bristol-Myers Squibb Company (BMS) and Pfizer Inc. announced findings from a real-world data analysis of the US Humana database, in which treatment with Eliquis (apixaban) was associated with a significantly lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin in patients aged 65 years and older with non-valvular atrial fibrillation (NVAF). The Humana database includes managed care medical and pharmacy claims from greater than 20 million persons primarily residing in the Southern and Midwestern regions of the US. This analysis was published  in the journal Current Medical Research and Opinion, with data from select cohorts also presented in a poster session at the ESC Congress 2017, organized by the European Society of Cardiology, in Barcelona, Spain (please see indications and important safety information for Eliquis later in this press release).

In this observational, real-world data analysis, NVAF patients with US Medicare Advantage insurance were identified in the Humana database by age (65 years and older), and having a pharmacy claim of Eliquis or warfarin between January 1, 2013, and September 30, 2015. The analysis evaluated rates of stroke/systemic embolism (including ischemic stroke, hemorrhagic stroke and systemic embolism) and major bleeding (including intracranial hemorrhage, gastrointestinal bleeding, and other major bleeding). Rates of stroke/systemic embolism and major bleeding were evaluated in the follow-up, based on hospitalization claims with the corresponding ICD-9-CM codes at the first position among the diagnosis codes associated with any of the inpatient claims. 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. Please see full methodology and additional limitations below.

“NVAF has long been identified as a significant risk for stroke, and its prevalence increases with age,” said Steven Deitelzweig, M.D., lead author of the publication and System Department Chair of Hospital Medicine, Ochsner Medical Center, New Orleans. “Real-world data such as this Humana database analysis provide further information to inform treatment decisions for select patient sub-populations, such as the elderly, in our everyday clinical practice.”

Eliquis, in this analysis, was associated with a lower risk of stroke/systemic embolism (hazard ratio [HR]:0.65, 95% confidence interval [CI]: 0.51 to 0.83, p=0.001) and lower rates of major bleeding (HR:0.53, 95% CI: 0.45 to 0.63, p=0.001) compared to warfarin. The mean duration of follow-up was 6.3 months for Eliquis and 8.3 months for warfarin. These findings supplement results from the landmark Phase 3 ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) clinical trial. Eliquis increases the risk of bleeding and can cause serious, potentially fatal, bleeding.

This analysis is part of the BMS-Pfizer Alliance global real-world data analysis program, ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies). Data sources for ACROPOLIS include de-identified medical records, medical and pharmacy health insurance claims data, and national health data systems, representing patient records across various populations and geographies.

“People aged 65 and older with non-valvular atrial fibrillation are approximately three to five times more likely to have a stroke than those without this disorder,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb (BMS). “Despite treatment advances over the past decade, a significant number of people in this age group with NVAF remain under-treated.”

“Through these real-world analyses, we continue to add to the growing body of evidence around the effects of Eliquis in commonly seen patient groups such as the elderly,” said Rory O’Connor, M.D., Chief Medical Officer, Pfizer Innovative Health. “The analyses from the ACROPOLIS program aim to supplement Eliquis’ randomized clinical trial results with insights gleaned from data collected across large patient populations and diverse clinical settings.”

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the US based on efficacy and safety data from multiple phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.

ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is the Eliquis (apixaban) global real-world data program designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program will include retrospective, outcomes-based analyses from over 10 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.

Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.


ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with non-valvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.