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Title: Rivaroxaban Approved in EU for the Prevention of Venous Thromboembolic Events
URL: http://www.pslgroup.com/dg/22DF7A.htm
Doctor's Guide
October 1, 2008

NEW YORK -- October 1, 2008 -- The European Commission has approved once-daily rivaroxaban (Xarelto), for the prevention of for the prevention of venous thromboembolic events in patients who have undergone elective total hip or knee replacement surgery.

The approval 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 (RECORD 1, 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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