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Title: Rivaroxaban Approved in Canada for the Prevention of Venous Thromboembolic Events
URL: http://www.pslgroup.com/dg/22C7DE.htm
Doctor's Guide
September 16, 2008

NEW YORK -- September 16, 2008 -- Health Canada has approved once-daily rivaroxaban (Xarelto), for the prevention of venous thromboembolic events in patients who have undergone elective total hip or total knee replacement surgery.

"[Rivaroxaban] has the potential to revolutionise how we prevent dangerous blood clots after elective total hip or knee replacement surgery in Canada," said principal investigator A.G.G. Turpie, MD, McMaster University, Hamilton, Ontario. "The existing treatment standards have limitations, so new therapies such as [rivaroxaban] can help doctors to prevent the potentially lethal effects of venous blood clots."

The approval from Health Canada was based on data from the extensive Regulation of Coagulation in Major Orthopaedic Surgery Reducing the Risk of DVT and PE (RECORD) clinical program that included 3 phase 3 trials of rivaroxaban involving nearly 10,000 patients undergoing elective hip or knee replacement surgery (RECORD1, 2, and 3 trials).

Results from these 3 studies demonstrated the efficacy of rivaroxaban compared with enoxaparin (RECORD1 and 3), and when compared with extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2). In all 3 trials, rivaroxaban and enoxaparin had similar safety profiles including low rates of major bleeding.


SOURCE: Bayer

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