New advances in thrombosis help further understanding of disease ...( As a direct thrombin inhibitor ximelag...)

As a direct thrombin inhibitor, ximelagatran in its activated form selectively inhibits free and clot-bound thrombin, a key enzyme in the body's coagulation pathway. Results showed that ximelagatran given 24 hours after total knee replacement surgery appeared to have increased efficacy and similar safety, without the need for coagulation monitoring or dose adjustment, when compared to warfarin.

The study, a double-blind, double-placebo phase III trial, compared a fixed dose of ximelagatran (36 mg twice a day [bid]) and warfarin (target INR 2.5; range 1.8-3.0). The 2,303 patients were randomized to either oral ximelagatran and warfarin placebo, or warfarin and ximelagatran placebo for seven to 12 days following surgery. Efficacy was measured by the number of subjects with confirmed venous thromboembolism and/or all-cause mortality. Safety was measured by rates of bleeding events (major and minor) and surgical wound assessment up to two days after the last dose of study drug was administered. The efficacy population was made up of 1,949 patients (982 received ximelagatran; 967 received warfarin). A slightly higher rate of venous thromboembolism and death was observed in patients receiving warfarin (31.9 percent) over patients on ximelagatran (22.5 percent). There was no statistically significant difference in safety between the two treatments. Ximelagatran provides better protection against venous thromboembolism without need for dose monitoring and with no increase in complications.

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Contact: Aimee Frank
amf@spectrumscience.com
202-955-6222
American Society of Hematology
6-Dec-2003

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