RE-LY trial establishes effectiveness of PRADAX in reducing stroke risk in AF patients

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.

"For over 50 years, physicians have had to treat patients in this area with medications, such as warfarin, that have imposed challenging restrictions on their patients," says Dr. Christian Constance, Cardiologist and RE-LY(R) Trial Investigator, University of Montreal, Maisonneuve-Rosemont Hospital. "It is exciting to see a new option that eliminates the need for lifelong blood tests, dose adjustments and the numerous food and drug interactions, while giving patients a considerably greater reduction of their risk of stroke."

"With the robust results from RE-LY(R) dabigatran etexilate, a compound from our own research and development, can revolutionize anticoagulant treatment for physicians and patients," commented Dr Andreas Barner, the chairman of the Board of Managing Directors of Boehringer Ingelheim. "We look forward to expeditiously submitting these results to regulatory authorities around the world so that new options can be made available for millions of patients with atrial fibrillation at risk of stroke."

These trial results will shortly be submitted by Boehringer Ingelheim (Canada) Limited to Health Canada seeking approval of PRADAX(R) in the AF indication. Upon approval the product will be available to Canadians.