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...

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

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