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Research Letter |

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

Ilke Sipahi, MD1,2; Seden Celik, MD1; Nurdan Tozun, MD3
[+] Author Affiliations
1Department of Cardiology, Acibadem University Medical School, Istanbul, Turkey
2Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio
3Department of Internal Medicine, Acibadem University Medical School, Istanbul, Turkey
JAMA Intern Med. 2014;174(1):150-151. doi:10.1001/jamainternmed.2013.12217.
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The US Food and Drug Administration (FDA) recently started an initiative called “Mini-Sentinel Program” to assess medical product safety using administrative-observational databases. One of the first utilizations of this program was to examine the bleeding risk of dabigatran in response to the unexpectedly high number of postmarketing reports of bleeding.1 However, there are major limitations of observational studies, and therefore the reliability of the Mini-Sentinel Program is unknown. Our objective was to compare the results of this program regarding the gastrointestinal (GI) tract bleeding risk of dabigatran vs warfarin with the results of randomized clinical trials (RCTs).

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Figure.
Meta-analysis of Randomized Clinical Trials Reporting Gastrointestinal (GI) Tract Bleeding With Dabigatran vs Warfarin (Fixed-Effect Model)

The squares represent the point estimates of risk ratio of individual trials, and the lines extending from them represent 95% CIs. The diamond represents the meta-analytic risk ratio and its 95% CI.

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