Author Interviews, Blood Clots, Case Western, Cleveland Clinic, JAMA / 24.11.2013
Dabigatran: Comparison Mini-Sentinel Clinical Trials and GI Bleeding
MedicalResearch.com Interview with:
Ilke Sipahi, MD
Department of Cardiology
Acibadem University Medical School, Istanbul, Turkey
Harrington Heart and Vascular Institute, University Hospitals Case Medical Cente, Case Western Reserve University School of Medicine, Cleveland, Ohio
MedicalResearch.com: Were you surprised at the extreme difference between these 2 analyses?
Answer: I was surprised. However, it is not unusual to find completely
contradictory results in medical studies. I was more surprised at the
fact that FDA paid more attention to it administrative observational
dataset rather than the huge large randomized clinical trials, all
showing excess GI bleeds with dabigatran (Pradaxa). Anyone who is even
slightly familiar with the medical literature knows that randomized trials are the gold standard in medical studies.
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