Why the study?
Does dabigatran increase the rate of bleeding events compared to warfarin?
Does dabigatran increase the rate of bleeding events compared to warfarin?
An FDA analysis of the Mini-Sentinel database demonstrated that real-world bleeding rates with dabigatran are not higher than those with warfarin.
Real-world data suggest similar bleeding rates for dabigatran and warfarin; leaves open questions on causality and generalizability.
Serious and fatal bleeding events associated with use of the anticoagulant dabigatran have been reported. The FDA used the Mini-Sentinel database to determine that the actual rates of bleeding events were not higher with dabigatran than with warfarin.
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Southworth et al. (2013) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: