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Anticoagulation
Study Shows New Drug Effective for Preventing Blood Clots
Ximelagatran without monitoring is as effective as warfarin for treatment of deep vein thrombosis (DVT),
according to the results of a recent study. Another randomized study showed that it was as effective as
well-controlled warfarin in preventing stroke, but a third study suggests that it may not be cost-effective for
that indication unless the patient is at high risk for intracranial bleeding or has a low quality of life while
taking warfarin. The FDA has not yet approved this drug because of concerns for health risks.
The study took place from September 2000 through December 2002 at 279 centers in 28 countries. In this double-blind,
noninferiority trial, 2,489 patients with acute DVT were randomized to receive six months of treatment with either
oral ximelagatran, 36 mg, twice daily or subcutaneous enoxaparin, 1 mg/kg, twice daily for five to 20 days followed
by warfarin adjusted to maintain an international normalized ratio (INR) of 2.0 to 3.0.
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A total of 9.6 percent of patients in the ximelagatran group had alanine aminotransferase levels (a measurement in the blood used as an indicator of possible liver damage or disease) increase to greater than 3 times the upper limit of normal, vs. 2.0 percent in the enoxaparin/warfarin group. Analysis of locally reported adverse events showed a higher rate of serious coronary events with ximelagatran (10/1,240 patients) compared with enoxaparin/warfarin (1/1,249 patients).
"In conclusion, for the initial and prolonged treatment of deep vein thrombosis, direct thrombin inhibition with oral ximelagatran, 36 mg. twice daily, was as effective as enoxaparin/warfarin, without the need for coagulation monitoring or dose adjustment. The mechanism and clinical importance of the increased liver enzyme levels in ximelagatran-treated patients requires further evaluation. Prospective assessment of coronary events in future studies is warranted," the authors write.
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