Breakthrough therapy dabigatran provides consistent benefit across all atrial fibrillation types and stroke risk groups

Ingelheim, Germany, April 4 2011 – New data from two RE-LY® sub-group analyses presented today at the 60 ^th Annual Scientific Session of the American College of Cardiology (ACC) demonstrated that dabigatran etexilate 150mg bid is consistently superior to warfarin in stroke prevention in atrial fibrillation (AF), irrespective of a patient’s risk of stroke or type of AF. ^1,2

RE-LY®, the largest AF trial to date, was a PROBE (prospective, randomised, open-label with blinded endpoint evaluation) trial designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. Pradaxa® 110mg bid was shown to be as effective as warfarin. ^3,4

The sub-group analyses assessed the rate of stroke and systemic embolism with dabigatran etexilate compared to well-controlled warfarin in patients with different types of AF (paroxysmal, persistent, permanent) and according to a refined stroke risk score CHA ₂DS ₂VASc, ⁵ which complements the traditionally used CHADS ₂ score ⁶ and has been recommended in current European guidelines. ⁵