Boehringer said that 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 from treatment with Dabigatran etexilate.
RE-LY trial included 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, which 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, Boehringer said.
In the trial, the 150mg 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.
Additionally, both doses (110mg BID and 150mg BID) also demonstrated reductions in intracranial bleeds versus well controlled warfarin, which support the overall striking results of RE-LY in the prevention of stroke and systemic embolism of Dabigatran etexilate 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.
Dabigatran etexilate has received approval, based on the convincing results of RE-LY, in the US for stroke risk reduction in patients with non-valvular AF and in Canada for the prevention of stroke and systemic embolism in patients with AF for whom anticoagulation is appropriate.