Apixaban has been approved in Canada for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).
Health Canada approved apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) as a new treatment option for Canadian patients with AF who typically require lifelong anticoagulation therapy to lessen their increased risk of stroke. Apixaban previously was approved in Canada for the prevention of venous thromboembolic events in adult patients who have already undergone elective knee or hip replacement surgery.
Health Canada’s approval was based on data from the ARISTOTLE and AVERROES studies, which evaluated nearly 24,000 patients. Canada patients were a significant proportion of participants in these trials. The studies compared apixaban with warfarin and acetylsalicylic acid, respectively, and looked at efficacy relating to stroke and systemic embolism and safety relating to major bleeding as the primary endpoints, and all-cause death as a secondary endpoint.
The trials demonstrated apixaban’s superior risk reduction compared with warfarin. ARISTOTLE results showed that apixaban was superior to warfarin in reducing stroke and systemic embolism in AF patients, while AVERROES results found that apixaban reduced the risk of stroke or systemic embolism by more than 50 percent in AF patients who were deemed unsuitable to receive vitamin K antagonists without increasing the risk of major bleeding or intracranial hemorrhage.