Interim Data Reported on Pradaxa vs. Warfarin and Major Bleeding Events

Interim results of a retrospective analysis comparing major bleeding events in patients treated with Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) and warfarin were announced at the American Heart Association’s Scientific Session 2014.

An analysis of 38,378 patients across two health insurance databases (MarketScan and UnitedHealth) showed that in routine care, non-valvular atrial fibrillation (NVAF), treatment with Pradaxa showed a 25% reduction in rate of major hemorrhage compared to warfarin (hazard ratio [HR] 0.75, 95% CI 0.65–0.87). Each database reflected a reduction in major hemorrhage with Pradaxa treatment: MarketScan (HR 0.78, CI 0.67–0.91) and UnitedHealth (HR 0.56, CI 0.36–0.86).

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In a separate MarketScan database analysis, treatment with Pradaxa showed a 46% reduction in the rate of stroke (HR 0.64, CI 0.44–0.95). An analysis of the UnitedHealth databse showed similar rates of stroke between Pradaxa and warfarin, possibly due to a low number of events.

Scientists concluded that while small incidence numbers (eg, stroke and systemic embolism) were limitations to the data, additional long-term data should reflect more stable estimates. This ongoing study program is expected to run through the end of 2016.

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