Author Interviews, Heart Disease, JAMA, University of Pittsburgh / 07.01.2015
Dabigatran Carries Risk of GI Bleeding; Risk Greater in Kidney Disease, Black Patients
MedicalResearch.com Interview with:
Inmaculada Hernandez, PharmD
PhD Student, Health Services Research and Policy
Deparment of Health Policy and Management
Graduate School of Public Health
University of Pittsburgh Pittsburgh, PA 15261
Medical Research: What is the background for this study? What are the main findings?
Response: The approval of dabigatran was considered a major contribution to the therapeutic arsenal of anticoagulants since warfarin, whose therapeutic management is complicated, was the only oral anticoagulant approved before 2011. Clinicians therefore considered dabigatran a very promising drug; however, the safety warnings released by the regulatory agencies and the reports of bleeding published in 2011 raised concerns about the safety profile of dabigatran. By the time we initiated our study, the FDA had concluded that dabigatran was associated with similar rates of bleeding than warfarin. However, the results of this observational study were not adjusted by patient characteristics. We therefore compared the risks of bleeding with dabigatran and warfarin adjusting for patient characteristics and using propensity score methods to mitigate selection biases, which observational studies are sensitive to.
We found that dabigatran was associated with a higher risk of major bleeding and gastrointestinal bleeding than warfarin. However, the risk of intracranial bleeding was lower with dabigatran. In addition, we found that the increased risk of bleeding with dabigatran was specially higher for African Americans and for patients with chronic kidney disease.
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