Positive long-term results with Pradaxa (Boehringer) in AF

Results from a new, long-term, combined analysis of the pivotal Phase III RE-LY trial and its extension safety study RELY-ABLE of Pradaxa (dabigatran etexilate mesylate), from Boehringer, in patients with non-valvular Atrial Fibrillation (NVAF) showed that after a median follow up of 4.6 years, with some patients followed up to 6.7 years, rates of stroke/systemic embolism and major bleeding were consistent with rates in previously reported analyses of RE-LY.

It showed that the rates of stroke or systemic embolism for dabigatran 150 mg BID and 110 mg BID were 1.25 percent and 1.54 percent per year, respectively. The low rates of hemorrhagic stroke seen during RE-LY (approximately one case per thousand per year) were observed over the whole duration of follow-up. Mortality rates were similar for the two dabigatran doses: 3.43 percent per year for 150 mg BID and 3.55 percent per year for 110 mg BID. The results were presented during the American Heart Association's Scientific Sessions 2013.