Results of the largest trial of its kind with over 18,000 atrial fibrillation patients published in the New England Journal of Medicine
Results of the landmark RE-LY(R) Trial (Randomized Evaluation of Long term anticoagulant therapy) demonstrate that atrial fibrillation (AF) patients taking PRADAX(R) (dabigatran etexilate) 150mg twice daily (BID) significantly reduced their risk of stroke and systemic embolism by 34 per cent (p less than 0.001) as compared to patients well-controlled on warfarin, without increasing the risk of major bleeding.
PRADAX(R) 110mg BID demonstrated similar reductions in stroke and systemic embolism compared to well-controlled warfarin while delivering a significant 20 per cent reductionThe results of dabigatran in RE-LY(R) exceeded all our expectations. We now have an oral treatment which offers superior protection from stroke with less bleeding and without the need for routine monitoring. In addition to protecting patients from strokes, we as physicians are especially concerned about life threatening or disabling bleeding with warfarin due to its narrow therapeutic window. On top of the efficacy, dabigatran has shown equally impressive safety results, offering a wider safety margin," commented Professor Stuart Connolly, co-principal investigator of RE-LY(R) and Director, Division of Cardiology at The Population Health Research Institute, McMaster University, Hamilton, Canada.
According to the Heart and Stroke Foundation of Canada, 250,000 Canadians currently diagnosed with AF are at least five times more at risk of having a stroke and twice as likely to die from one. In Canada, stroke is the third leading cause of death with up to 15 per cent of strokes being caused by AF. This number increases to one-third of all strokes for those over the age of 60.