Dabigatran etexilate demonstrates substantial clinical benefits in atrial fibrillation patients with prior stroke or transient ischaemic attack

Ingelheim, Germany, 8 November, 2010. Today, The Lancet Neurology published positive results from a sub-group analysis of the landmark Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY®) trial - the largest atrial fibrillation (AF) outcomes trial ever completed (18,113 patients in 44 countries worldwide). The new findings fully support the convincing results from the
RE-LY® trial and show that AF patients with previous stroke or transient ischemic attack (TIA) may benefit substantially from treatment with dabigatran etexilate. ^1,2,3

The new sub-group analysis from RE-LY® included 3,623 AF patients who had suffered a stroke or TIA before enrolment into the trial. The results of the sub-group analysis were consistent with the overall trial results for the major efficacy and safety outcomes. This was confirmed by an interaction analysis which showed that results in patients with previous stroke or TIA were consistent with the overall results found in the RE-LY® trial. ^1,2,3

The 150 mg dose of dabigatran etexilate provided a substantial 25% reduction in relative risk compared with well controlled warfarin in the combined endpoint of stroke and systemic embolism in the sub-group of patients with previous stroke or TIA in line with the results of the main RE-LY® trial. However, due to the five fold smaller sample size of this subpopulation compared to RE-LY®, this difference did not reach statistical significance. Impressively, both doses (110 mg BID and 150 mg BID) also demonstrated significant reductions in intracranial bleeds versus well controlled warfarin.1 These findings support the overall striking results of RE-LY® in the prevention of stroke and systemic embolism of dabigatran etexilate, ^2,3 within a patient sub-group who are at 2.5 times increased risk compared with a typical AF patient without previous stroke or TIA, who themselves are already at 5-times increased risk. ^4,5,6

Addendum: RE-LY® 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 (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. Pradaxa® 110 mg bid was shown to be as effective as warfarin. Both doses of Pradaxa® showed significantly lower intracranial bleeding compared to well-controlled warfarin. ^2,3