Pradaxa (dabigatran etexilate) gets approval for stroke prevention in AF patients in Europe

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The European Commission approved Boehringer Ingelheim’s oral anticoagulant Pradaxa (dabigatran etexilate), for the prevention of stroke in patients with atrial fibrillation (AF) at risk of stroke. For the first time in 50 years, this approval gives AF patients access to a new treatment for the prevention of AF-related strokes in Europe.

The EC has approved the use of dabigatran etexilate in the EU for the prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors. While overall the 150mg bid dose is recommended for the majority of patients, the 110mg bid dose is specifically available for elderly patients aged 80 years or above, for patients at increased risk of bleeding and for patients who are co-administered with dabigatran etexilate and the calcium channel blocker verapamil.


Professor Gregory Lip, consultant cardiologist and professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, Birmingham, United Kingdom commented, “The approval of dabigatran etexilate in Europe represents a major advance in the treatment of this condition. For the past 50 years physicians worldwide have been waiting for an alternative to vitamin K antagonist therapies, such as long time standard of care, warfarin.” He continued, “Whilst effective, warfarin has many limitations such as the need for regular monitoring and various food-drug and drug-drug interactions, resulting in only half of eligible patients receiving warfarin and fewer than half of these patients being controlled within the desired therapeutic range.”


Trudie Lobban, CEO of the Atrial Fibrillation Association added, “Atrial fibrillation raises the risk of stroke by five times, resulting in up to three million people worldwide suffering strokes related to this condition each year. Atrial fibrillation-related strokes are particularly severe and disabling, with one half of this population dying within one year after a stroke.”


The approval of dabigatran etexilate for stroke prevention in AF patients is based on the results from RE-LY, one of the largest studies ever conducted in AF including over 18,000 patients. RE-LY was a PROBE (prospective, randomised, open-label with blinded endpoint evaluation) trial, comparing two 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 is the only novel oral anticoagulant approved for stroke prevention in AF in Europe that has been proven superior to well-controlled warfarin (median TTR 67%). Dabigatran etexilate 150mg bid reduced the risk of stroke and systemic embolism by 35% while also significantly lowering the risk of life-threatening and intracranial bleeding, compared to well-controlled warfarin. Dabigatran etexilate 110mg bid has been shown non-inferior to warfarin in reducing the risk of stroke and systemic embolism with a significantly lower rate of major bleeding.


Stuart Connolly, co-principal investigator of RE-LY, director, Division of Cardiology at McMaster University and member of The Population Health Research Institute, Hamilton, Ontario, USA, added, “The landmark RE-LY study results also showed us that dabigatran etexilate is consistently effective at 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.”


In addition to the approval in Europe, dabigatran etexilate has already been approved for the prevention of stroke in atrial fibrillation in the USA, Canada, Japan, Australia and several other countries. In 2008 dabigatran etexilate was granted EU approval for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip or elective total knee replacement surgery.