24 Nov 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.
MedicalResearch.com: How should clinicians react to these findings? What do we tell patients?
Answer: Clinicans should know the Pradaxa leads to more GI bleeds compared to
the old anticoagulant. Pradaxa is commonly market as a drug that leads
to both fewer bleeding events, as well as fewer events due to blood
clots. This does not hold true for GI bleeds. Indeed Pradaxa leads to
more GI bleeds. Physicians should be very cautious to use these drugs
in patients with history of GI problems. Perhaps even more
importantly, one of our previous study shows that Pradaxa also leads
to an increased risk of heart attacks. So this is a drug with
extremely important side effects and patients should know these important facts.
MedicalResearch.com: What main message would you hope for physicians to take away from this research?
Answer: Once again we see that the side effect profile of a new drug is not
known well at the time of approval of the drug. The last few years’
research shed light on to the adverse effects of Pradaxa. While the
introduction of these new anticoagulants is an important step forward
in medicine, we should know that in medicine newer is not necessarily
better in every aspect.
A Comparison of Results of the US Food and Drug Administration’s Mini-Sentinel Program With Randomized Clinical Trials The Case of Gastrointestinal Tract Bleeding With Dabigatran
Sipahi I, Celik S, Tozun N. A Comparison of Results of the US Food and Drug Administration’s Mini-Sentinel Program With Randomized Clinical Trials: The Case of Gastrointestinal Tract Bleeding With Dabigatran. JAMA Intern Med. 2013;():-. doi:10.1001/jamainternmed.2013.12217.
Last Updated on January 5, 2015 by Marie Benz MD FAAD