Health Canada, the Canadian health authority, has approved Pradax (dabigatran etexilate), Boehringer Ingelheim’s novel, oral direct thrombin inhibitor for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) in whom anticoagulation is appropriate, marking the second approval of this new oral anticoagulant following the recent marketing authorisation by the US Food and Drug Administration (FDA). The Health Canada approval makes Pradax available to AF patients in Canada, with the flexibility of two dosing regimens. While overall the 150 mg bid dose is recommended, the 110 mg bid dose is specifically available for elderly patients aged 80 years and above as well as for patients at high risk of bleeding.

The approval is based on findings from RE-LY, the largest AF trial completed to date and is set to provide a breakthrough for stroke prevention in AF – a condition that affects 250,000 people in Canada alone. The results demonstrated that dabigatran etexilate 150 mg significantly reduced the risk of stroke and systemic embolism by 35 per cent beyond the reduction achieved with warfarin, the longtime standard of care, while the risk of major bleeding events was similar. Compared to well controlled warfarin, dabigatran etexilate 110 mg bid was associated with a similar reduction of stroke and systemic embolism but a lower rate of major bleeding. Importantly, both doses provided a reduction in intracranial and life-threatening bleeding, as well as in total bleeding, compared with warfarin. Besides providing superior efficacy compared to warfarin, dabigatran etexilate does not require monitoring or related dose adjustments, is not affected by food, and no dose adjustment is required for many common co-medications in patients with AF.

“Dabigatran etexilate is a significant advance in medicine. We have been waiting a long time for an alternative to warfarin. For decades, we have had no other choice than to use warfarin in the majority of patients, a treatment that imposes challenging restrictions on people’s quality of life,” said Dr 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. “It is really great to finally have a safer and more effective alternative for patients with AF, which is easier to use. The approval of dabigatran etexilate will transform the way we treat and manage patients with AF at risk of stroke.”  

Coinciding with the Health Canada approval of Pradax, the Canadian Cardiovascular Society (CCS) has released new guidelines on stroke prevention in AF, which contain guidance on the use of dabigatran etexilate. Based on the safety and efficacy profile of Pradax, the guidelines generally recommend its use over warfarin for overall stroke reduction, particularly the 150mg dose twice-daily.

Professor Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim said, “The approvals of dabigatran etexilate for stroke prevention in AF in North America are good news for patients and physicians, who now have access to a novel agent that has the potential to change the treatment paradigm in this indication. The decision of Health Canada marks another important step towards our goal to make this treatment available to all patients with atrial fibrillation at risk of stroke. We are working with regulatory authorities worldwide to ensure this.”

RE-LY (Randomized Evaluation of Long term anticoagulant therapY) was a global, phase III, randomised trial of 18,113 patients enrolled in over 900 centres in 44 countries, investigating whether dabigatran etexilate (2 blinded doses) is as effective as well controlled warfarin with target INR of 2.0-3.0 for stroke prevention.