RELY-ABLE trial shows long-term safety profile of Pradaxa (Boehringer) in patients with Atrial Fibrillation

Results from the RELY-ABLE trial, a long-term extension of the pivotal RE-LY study of Pradaxa (dabigatran etexilate), from Boehringer, in patients with non-valvular Atrial Fibrillation (NVAF), reinforces the drug's profile with encouraging long-term safety results. Patients enrolled in RELY-ABLE continued Pradaxa therapy dosing, bringing the mean duration of treatment to 4.3 years. A total of 5,851 patients participated in the extension. Rates of major bleeding, the primary endpoint, were 3.74% per year (Pradaxa 150mg) and 2.99% per year (110mg). Major gastrointestinal bleeding occurred at rates of 1.54% per year (150mg) and 1.56% per year (110mg).

Secondary endpoints included other key safety outcomes, such as total bleeding and life-threatening bleeding, and showed similar results as RE-LY, with no new safety findings. Rates of stroke or systemic embolism were slightly higher in RELY-ABLE than RE-LY partly due to the fact that there was no event adjudication, which either confirmed reported events or rejected them. Data are published in Circulation: "The Long Term Multi-Center Observational Study of Dabigatran Treatment in Patients with Atrial Fibrillation: (RELY-ABLE) Study." Stuart J. Connolly et al. Circulation 2013; first published June 14 2013 doi:10.1161/CIRCULATIONAHA.112.001139