Health Canada Approves PRADAX as Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation
By Mellanie True Hills
October 27, 2010—On the heels of the US FDA approving dabigatran, the long-awaited alternative to Coumadin (warfarin), comes word that Health Canada has as well. In Canada, dabigatran is known as PRADAX™. Because this is the first alternative to warfarin in Canada, it is big news for the afib community there.
Like the FDA, Health Canada approved dabigatran based on the strength of the results of the Randomized Evaluation of Long-Term Anticoagulant Therapy trial, known as the RE-LY trial, in which patients on dabigatran had fewer strokes compared to those on warfarin. Find out more information about the RE-LY trial in Dabigatran Better than Warfarin for Stroke Prevention in Atrial Fibrillation.
The FDA and Health Canada both approved the 150 mg dose for most afib patients, and while the FDA approved a 75 mg dose for those with renal (kidney) issues, Health Canada approved a 110 mg dose for those age 80 years and above and for those at higher risk of bleeding. This approval coincided with release of the new Canadian Cardiovascular Society (CCS) guidelines on stroke prevention in atrial fibrillation, which recommended PRADAX™ over warfarin for stroke reduction.
Read related information:
- Dabigatran Better than Warfarin for Stroke Prevention in Atrial Fibrillation
- PRADAX™ (dabigatran etexilate) gains approval in Canada for stroke prevention in atrial fibrillation
- Canadian update to the AF guidelines: Role for dabigatran already in place
Disclaimer: Patients come first at StopAfib.org, and we do not compromise on that. However, even though Boehringer Ingelheim, the maker of Pradax™, is a donor to StopAfib.org, we believe that this news is so significant for the afib community that we absolutely must share it immediately.