New RE-LY® sub-analyses demonstrate safety and efficacy of Pradaxa® (dabigatran etexilate) in patients with heart failure & those undergoing surgery

• Pradaxa® 150mg bid reduced the risk of stroke in atrial fibrillation patients with symptomatic heart failure (sHF) compared to well-controlled warfarin 1 • Rates of major bleeding in patients with sHF taking Pradaxa® are consistent with results seen in the RE-LY® trial, with...

Orlando, U.S., 14 November 2011 – A new post hoc sub-analysis of the RE-LY® trial found Pradaxa® (dabigatran etexilate) 150mg bid significantly reduced the risk of stroke compared to well-controlled warfarin (median time in therapeutic range (TTR) 67.3% 5) in patients with non-valvular atrial fibrillation (AF) and symptomatic heart failure (sHF). Importantly, the benefit for Pradaxa® compared to well-controlled warfarin with regard to major bleeding was maintained, irrespective of sHF. 1 The results were presented today at the American Heart Association (AHA) Scientific Sessions 2011.

The landmark RE-LY® trial was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial of 18,113 patients enrolled in over 900 centres in 44 countries. The trial was designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran (110mg and 150mg bid) each administered in a blinded manner, with well controlled (INR 2.0-3.0, median TTR 67% 5) open label warfarin. 2

Heart failure is a serious condition that occurs when the heart is unable to pump enough blood to meet the body’s needs. Up to 45% of patients with heart failure present with AF, which results in an increased risk of stroke and mortality above that seen in AF alone. 6 Heart failure can also increase the risk of bleeding in patients using anticoagulation therapy. 7