News | Antiplatelet and Anticoagulation Therapies | November 16, 2017

BMS-Pfizer Alliance Releases Real-World Data on Oral Anticoagulants in Non-Valvular Atrial Fibrillation

Analyses on cost, safety and comparative effectiveness use two large U.S. databases to provide insights on apixaban, warfarin and other direct oral anticoagulants

November 16, 2017 — Bristol-Myers Squibb Company and Pfizer Inc. released real-world data (RWD) of outcomes associated with direct oral anticoagulants (DOAC) among non-valvular atrial fibrillation (NVAF) patients during the 2017 American Heart Association (AHA) Scientific Sessions, Nov. 11-15 in Anaheim, Calif. The data was compiled using the U.S. Medicare database – the nation’s largest insurer handling more than 1 billion total claims per year – as well as the Department of Defense (DoD) Military Health System (MHS).

The RWD analysis of the DoD MHS database evaluates all-cause, stroke/systemic embolism (S/SE) and major bleeding (MB)-related medical costs associated with Eliquis (apixaban), warfarin and other DOACs among NVAF patients. Two analyses of the Medicare database evaluate the risk of S/SE and rates of MB in elderly NVAF patients, with one of these analyses focusing on those patients with concomitant coronary artery disease/peripheral arterial disease (CAD/PAD). Since CAD/PAD are comorbidities that substantially increase the risk of future cardiovascular events in patients with NVAF,ii this analysis also evaluates major adverse cardiac events (MACE).

“A clearer understanding of the outcomes of comorbid NVAF populations in routine clinical practice may help inform a patient’s treatment course,” said Renato Lopes, M.D., Ph.D., professor of medicine, Duke University School of Medicine. “More information is needed around stroke and cardiovascular outcomes for NVAF patients with concomitant CAD and PAD, and further exploring DOACs and their association with outcomes such as stroke, major bleeding and MACE events in NVAF patients is an important step towards providing additional information to physicians when considering treatment decisions.”

These analyses stem from the Bristol-Myers Squibb (BMS)-Pfizer Alliance global RWD analysis program, ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), which is working to grow the body of evidence around the stroke risk reduction effects and other outcomes associated with Eliquis in highly representative patient groups and common clinical settings. Eliquis is a prescription medicine indicated to reduce the risk of S/SE in patients with NVAF.

Studies have shown that approximately 18 percent of patients with NVAF had concomitant vascular disease (CAD/PAD). The presence of PAD in patients with NVAF has been associated with higher rates of mortality, cardiovascular events and stroke. Similarly, atherosclerosis (plaque buildup that causes CAD) in patients with NVAF carries a higher risk of cardiovascular events (including cardiovascular death, myocardial infarction, stroke, and hospitalization for an atherothrombotic event).iii

As observational studies lack randomization, they can only analyze associations and not causality. In these studies, comparisons between groups of patients can be subject to potential selection bias and other limitations such as confounding. The source and type of database may also limit the ability to generalize the results and endpoints to the overall population. Therefore, real-world data should not be used as stand-alone evidence for treatment evaluation.

Links to other AHA 2017 Late-breaking Trials

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