Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Boehringer Ingelheim has received approval from the European Commission (EC) for Pradaxa (dabigatran etexilate) as a preventive measure for stroke in patients suffering from atrial fibrillation (AF).
Subscribe to our email newsletter
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.