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Direct thrombin inhibitor cuts recurrent DVT.

SAN DIEGO -- Treatment to prevent recurrent deep vein thrombosis using the direct thrombin inhibitor, ximelagatran, was equivalent to enoxaparin and warfarin over 6 months, Dr. Charles W. Francis said at the annual meeting of the American Society of Hematology.

In the trial, 1,240 patients with acute deep vein thrombosis received ximelagatran (36 mg twice daily) and 1,249 patients received standard therapy with enoxaparin for 5 days followed by warfarin for 6 months.

A total of 37 venous thrombotic events or major bleeding episodes occurred in patients treated with ximelagatran, compared with 43 events in patients who received standard treatment. Concerning venous thromboembolism events alone, there were 26 in ximelagatran-treated patients and 24 in standard-therapy patients.

The findings show that the two approaches are equivalent. The advantage of ximelagatran is that it is oral and does not require close monitoring of patients, noted Dr. Francis, a professor of medicine at the University of Rochester (N.Y.).

In the ximelagatran group, 10% of patients experienced serum alanine aminotransferase elevations that were three times the upper limit of normal. But in most cases, those elevations were somewhat transient.

The peak of this elevation occurred at about 3 months into treatment, and then it waned, so that at the end of treatment at 6 months, 36 of 43 patients had returned to normal, Dr. Francis said.

In an interview, Dr. Francis said that it is difficult at this point to say how clinically significant the ALT elevations are. "Even with this many patients, it's hard to know how many actually got sick."

A number of trials of ximelagatran--one of at least five direct thrombin inhibitors in various stages of development--have recently been reported. Like this trial, the other trials were designed to show that the agent is not inferior to standard therapy, which is what is required for Food and Drug Administration approval for a given indication. Dr. Francis' trial was supported by AstraZeneca.

BY TIMOTHY F. KIRN

Sacramento Bureau
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Title Annotation:Ximelagatran
Author:Kirn, Timothy F.
Publication:Internal Medicine News
Date:Feb 15, 2004
Words:328
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