Guidance adherent dabigatran etexilate treatment versus warfarin in the RE-LY population: an analysis on the basis of the European label recommendations for dabigatran etexilate

Abstract

Purpose: In the RE-LY trial, patients were randomized to arms independent of baseline characteristics; dabigatran 150 mg twice daily (BID; D150) was associated with significantly fewer strokes and dabigatran 110 mg BID (D110) with significantly fewer major bleeding events, compared to well controlled warfarin. The European (EU) label recommends D150 in patients <80 years without an increased risk for bleeding or concomitant verapamil and D110 in other patients. In this analysis of the RE-LY dataset, we simulated how dabigatran, when used according to the label, would compare to well controlled warfarin. Methods: In this post hoc, non-randomized analysis, we simulated the outcomes of patients receiving dabigatran with a dose selected according to the label and compared them to the warfarin-treated patients. Results: EU label simulated dabigatran treatment was associated with significant reductions in stroke and systemic embolism, haemorrhagic stroke, death and vascular death compared to warfarin; also with significant reductions in major and life-threatening bleeding and intracranial haemorrhage, but not gastrointestinal major bleeding, compared to warfarin (table). label simulated dabigatran outcomes were not significantly different from those of patients receiving D150 in RE-LY. View this table: Conclusion: This post hoc, non-randomized analysis of the RE-LY trial suggests that EU label adherent dabigatran treatment may be associated with superior efficacy and safety compared to warfarin.