Real world GLORIA-AF study confirms low major bleeding and stroke rates with Pradaxa (dabigatran) for stroke prevention in atrial fibrillation.- Boehringer.

New data from a completed Phase II study of GLORIA-AF, one of the largest prospective ongoing global studies examining the use Pradaxa (dabigatran), from Boehringer, for stroke prevention in atrial fibrillation (AF) showed low rates of major bleeding (0.97%) and stroke (0.65%). The registry examined two-year safety and effectiveness outcomes of nearly 5,000 AF patients treated with dabigatran. In an additional analysis from GLORIA-AF2 the safety of uninterrupted dabigatran for patients undergoing cardiovascular (CV) interventions was evaluated. The rates of major bleeding and stroke/ systemic embolism were very low, i.e. one major bleed and one systemic embolic event occurred in 412 CV interventions that were performed with uninterrupted dabigatran. These findings confirm the sustained safety and effectiveness of dabigatran and are highly consistent with the long-term safety profile observed in other real-world evidence, as well as in randomised clinical trials. Results were presented at the EHRA 2018, the annual congress of the European Heart Rhythm Association (EHRA).