MedicalResearch.com Interview with:
Todd C. Villines, M.D. FSCCT
Professor of Medicine
Uniformed Services University School of Medicine
Director of Cardiovascular Research and Cardiac CT
Cardiology Fellowship Program Director
Walter Reed National Military Medical Center
Assistant Professor of Medicine
Georgetown School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study was a retrospective, observational real-world analysis assessing the safety and effectiveness of novel oral anticoagulants (NOACs) among patients with non-valvular atrial fibrillation (NVAF) treated through the U.S. Department of Defense Military Health System. The study examined major bleeding and stroke rates in NVAF patients who had initiated treatment with dabigatran compared to those treated with rivaroxaban or apixaban.
The study examined two cohorts: one that resulted in 12,763 propensity score matched dabigatran (150 mg bid) and rivaroxaban (20 mg daily) patients, and another that resulted in 4,802 propensity score matched dabigatran (150 mg bid) and apixaban (5 mg bid) patients. Dabigatran patients demonstrated lower rates of major bleeding compared to rivaroxaban patients (2.08 percent vs 2.53) percent and similar rates of stroke (0.60 percent vs 0.78 percent). In the exploratory analysis, dabigatran and apixaban patients showed similar rates of major bleeding (1.60 percent vs 1.21 percent) and stroke (0.44 percent vs 0.35 percent).
MedicalResearch.com: What should readers take away from your report?
Response: An increasing number of the 2.7 million Americans living with atrial fibrillation are treated with NOACs. This large-scale, U.S. practice-based comparison should provide additional insight on available NOAC therapies, including dabigatran. The analysis found that Pradaxa patients had a lower risk of major bleeding compared to rivaroxaban patients and similar risk compared to apixaban patients. There was no difference in stroke risk between Pradaxa patients and rivaraoxaban or apixaban patients. Dabigatran, through 11 real-world studies with over seven years of analysis, has the longest real-world experience of any available NOAC, and this data analyses reinforces its safety and effectiveness in a large population of patients. Analyses like this one are important because they continue to show how dabigatran is performing in the real world and impacting patients, which is an important outcome.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: While many studies have examined real-world outcomes with NOACs relative to warfarin, there is limited data comparing NOACs against each other in terms of risk of major bleeding and stroke. Continuing to assess NOACs in the real-world setting is important for ensuring that physicians have the information they need to care for patients.
MedicalResearch.com: Is there anything else you would like to add?
Response: This real-world comparison is not intended to suggest a clinical comparison between NOACs. The approved labelling for dabigatran does not include data comparing the product to other NOAC therapies, and there are no clinical trials providing a head-to-head comparison of NOAC therapies. Dabigatran is indicated to reduce the risk of stroke and systemic embolism in patients with NVAF.
For the millions of Americans with atrial fibrillation, novel oral anticoagulants can play an important role in reducing the risk of stroke. I am proud to contribute to research that can help broaden our knowledge of these important treatments and their potential impact for patients.
Abstract 100: Comparative Safety and Effectiveness of Dabigatran Versus Rivaroxaban and Apixaban Utilized Among United States Department of Defense Healthcare System Patients
Todd C Villines, Ashar Ahmad, Amber Evans, Kelly Oh, Michaela Petrini, Toni Rush, Wenbo Tang, David Thompson, Eric Schwartzman
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