Pradaxa® (dabigatran etexilate) revolutionizes stroke prevention in atrial fibrillation

Ingelheim, Germany, 26 August 2011 – Boehringer Ingelheim today announced that more than 350,000 patients have already been prescribed Pradaxa® (dabigatran etexilate) for stroke prevention in non-valvular atrial fibrillation (AF) less than 10 months following its approval in the U.S., Canada and Japan. ^1,2,3 Latest data shows that cardiologists have broadly adopted the breakthrough treatment in the U.S. and 9 out 10 that treat a majority of AF patients have prescribed it (n=14,019) ⁴

Dabigatran etexilate was the first novel oral anticoagulant approved ^5-9 for stroke prevention in AF since the current standard of care warfarin was made available 55 years ago. These approvals were based on the landmark RE-LY® trial, which showed that dabigatran etexilate 150mg bid was significantly superior in reducing the risk of stroke or systemic embolism by an additional 35% compared to well-controlled warfarin ^10,11 (median TTR 67% ^4,5), while at the same time demonstrating significant reductions in intracranial and life threatening bleeds. ¹⁰ The RE-LY® results were demonstrated in the intention-to-treat population, the accepted standard for reporting superiority in clinical trials. ¹² The RE-LY® trial was a PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. ¹³