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).
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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