Dabigatran etexilate is indicated as a preventive measure for stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors.
The EC approval is supported by the results of RE-LY study, a prospective, randomized, open-label with blinded endpoint evaluation (PROBE) trial, which compared fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.
Dabigatran etexilate 150mg bid showed reduction in the risk of stroke and systemic embolism by 35% while also lowering the risk of life-threatening and intracranial bleeding, compared to well-controlled warfarin.
RE-LY co-principal investigator Stuart Connolly said the study results also showed that dabigatran etexilate is consistently effective in preventing strokes across a wide range of patients with AF, irrespective of age, gender, stroke risk, type of atrial fibrillation, prior stroke, and comorbidities such as hypertension and diabetes.