Anticoagulant does not need monitoring
Ximelagatran (Exanta), a direct thrombin inhibitor,
is as effective as warfarin as prophylaxis against venous thromboembolism
(VTE) and does not require routine coagulation monitoring or dose adjustment.
This was the opinion of Dr Charles Francis, University
of Rochester, New York, who presented the results of a phase III study
involving warfarin and ximelagatran at the 18th congress of the International
Society on Thrombosis and Haemostasis in Paris last month. The study compared
the efficacy and safety of treatment for seven to 12 days with either
24mg ximelagatran twice daily or dose-adjusted warfarin once daily in
680 patients who had undergone total knee replacement. The overall incidence
of VTE was 19.2 per cent in patients who received ximelagatran and 25.7
per cent in those who were given warfarin.
The incidence of major bleeding and any bleeding
was 1.7 per cent and 9.0 per cent, respectively, in the ximelagatran group.
The equivalent figures for the patients who took warfarin were 0.9 per
cent and 7.0 per cent. These figures were not significantly different.
In addition, monitoring and dose adjustment were not needed with ximelagatran,
Dr Francis said.
AstraZeneca, the manufacturer of ximelagatran, says
that phase III studies are under way to investigate the efficacy of the
drug in stroke prevention in patients with atrial fibrillation.
The initial filing for the indication of prevention
of VTE in patients undergoing elective hip and knee replacement is expected
in Europe at the end of 2002. That for prevention of stroke in patients
with atrial fibrillation is expected in Europe by the middle of 2003.
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