A sub-group analysis of the late-stage

RE-LY trial showed that Boehringer Ingelheim's oral anticoagulant Pradaxa (dabigatran etexilate) led to greater reductions in stroke compared to warfarin, in patients with atrial fibrillation, irrespective of their risk profile for stroke, the company announced Monday.

Presented at the American College of Cardiology meeting, the study involved 18 113 patients with atrial fibrillation (AF) who were randomised to treatment with either one of two doses of twice-daily Pradaxa or warfarin.

Results demonstrated that for the three subsets of patients in the trial who were defined as being at low, moderate and high risk of stroke, those patients who received Pradaxa 150-milligram had a lower rate of stroke and systemic embolism compared with warfarin. Additionally, both doses of Pradaxa were associated with lower rates of major bleeding in patients at low risk of stroke, the company said.

Commenting on the results, researcher Jonas Oldgren noted that about half of low-risk patients aren’t given warfarin because of the risk of side effects, but Pradaxa "is better, or at least as good as, warfarin on stroke reduction and better concerning safety with bleeding risk,” adding that "we clearly can expand the patient group that gets treatment.”

Previous results from the RE-LY study have shown that patients administered the higher dose of Pradaxa had a 34-percent lower risk of stroke and systemic embolism, compared with those taking warfarin. Data from the trial has also demonstrated that the anticoagulant was as effective as warfarin in reducing the risk of subsequent stroke in patients with AF.