eemed to experience a higher incidence of major bleeding over that of standard therapy (0.7 percent - 25 mg bid; 4.1 percent - 50 mg bid; 3.5 percent - 75 mg bid; and 5.8 percent - 100 mg bid versus 0.0 percent - enoxaparin 30 mg bid). The three highest doses of razaxaban were stopped before the intended sample size of 150 patients was reached, due to increased reports of bleeding. In this study, the lowest dose of razaxaban, 25 mg bid, demonstrated potential for increased efficacy and similar safety compared to current standard treatment.

Randomized, Double-Blind Comparison of Ximelagatran, an Oral Direct Thrombin Inhibitor, and Warfarin to Prevent Venous Thromboembolism (VTE) after Total Knee Replacement (TKR): EXULT B (Abstract 39)

Total knee replacement surgery, like many other major orthopedic surgeries, continues to be hampered by venous thromboembolism events, such as deep vein thrombosis and pulmonary embolism. Without any preventive medication, harmful blood clots occur in two thirds of all total knee replacement surgery patients. Anticoagulants that are currently approved in the U.S. for prevention of venous thromboembolism are still associated with unacceptably high rates of deep vein thrombosis and require regular dosage monitoring to prevent major bleeding events.

"Oral anticoagulants that are currently available have many limitations. There is a great need for new therapies with increased safety and efficacy," said Charles Francis, M.D., of the University of Rochester, Rochester, N.Y., lead investigator of the study. "The results from this study encourage us to continue looking at ximelagatran as a preventive treatment for this serious complication in total knee replacement surgery."

The trial, led by Dr. Francis, compares the safety and efficacy of ximelagatran, a novel oral direct thrombin inhibitor, to warfarin for prevention of venous thromboembolism in total knee replacement patients.
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Contact: Aimee Frank
amf@spectrumscience.com
202-955-6222
American Society of Hematology
6-Dec-2003

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