Bristol-Myers Squibb and Pfizer present large real-world observational analysis of the effectiveness and safety of direct oral anticoagulants compared to warfarin in patients with non-valvular atrial fibrillation.
Bristol-Myers Squibb Company and Pfizer Inc. 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, were 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
“Studies such as this large U.S. Medicare database analysis supplement pivotal trials by broadening and deepening our scientific knowledge of how patients respond to direct oral anticoagulants in everyday clinical practice,” said Alpesh Amin, M.D., principal investigator and Professor of Medicine, University of California, Irvine. “Given the diversity of patients with non-valvular atrial fibrillation, analyses of real-world data provide further information that adds to data generated in randomized clinical trials.”
Eliquis, in this analysis, was associated with a significantly lower risk of stroke or systemic embolism (HR: 0.40, 95% CI: 0.31-0.53; p<0.0001) and lower rate of major bleeding (HR: 0.51, 95% CI: 0.44-0.58; p<0.0001) than patients treated with warfarin. The findings from the Eliquis-warfarin cohort complement the results of the randomized Phase 3 ARISTOTLE (Apixaban for Reduction In Stroke and Other ThromboemboLic Events in Atrial Fibrillation) trial.iv For data on other cohorts, please refer to the full abstract.
“The U.S. Medicare system currently covers more than 57 million Americans,v including over two million who have been treated with anticoagulants,” said Rory O’Connor, M.D., Chief Medical Officer, Pfizer Innovative Health. “Increasingly, real-world data analyses are being utilized to enhance the understanding of data associated with health interventions. With the advent of large, representative and anonymized datasets, such as records from the Centers for Medicare & Medicaid Services, we can provide additional information that clinicians can use in their treatment decisions.”
“The Bristol-Myers Squibb and Pfizer Alliance continues to invest heavily in research analyses that provide more information on care for patients with non-valvular atrial fibrillation,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “Our real-world data program — ACROPOLIS — aims to generate evidence from routine clinical practice settings by analyzing patient databases around the world, including medical records, medical and pharmacy health insurance claims data and national health data systems.”
i Amin A, Keshishian A, Trocio J, et al. Effectiveness and safety of apixaban, dabigatran, and rivaroxaban compared to warfarin among non-valvular atrial fibrillation patients in the US Medicare population. Presented at the 66th Annual American College of Cardiology (ACC) Scientific Session; March 17, 2017; Washington, D.C.
ii Garrison LP, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR real-world data task force report. Value Health. 2007;10:326-335.
iii Hannan EL. Randomized clinical trials and observational studies. J Am Coll Cardiol Intv. 2008;1:211-217.
iv Granger, CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-992.
(Source: Business Wire)
Filed Under: Drug Discovery