Health Canada, the Canadian health authority, has approved PRADAX™ (dabigatran etexilate), 1 Boehringer Ingelheim’s novel, oral direct thrombin inhibitor 2 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, 1 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 higher 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. 3 The results demonstrated that dabigatran etexilate 150 mg significantly reduced the risk of stroke and systemic embolism by 35 percent 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. 4 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.