Simpler blood thinning medication effective for preventing blood clots ...( mbolism occurred in 26 and 24 patients ...),Health

mbolism occurred in 26 and 24 patients in the ximelagatran and enoxaparin/warfarin groups, respectively, corresponding to estimated cumulative risks of 2.1 percent and 2.0 percent. The absolute difference between ximelagatran and enoxaparin/warfarin was 0.2 percent. This met the prespecified criterion for non-inferiority. The cumulative risk of major bleeding at 6 months in the ximelagatran-treated patients was 1.3 percent compared with 2.2 percent for those receiving enoxaparin/warfarin. All-cause death was not significantly different between the 2 groups.

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.
(JAMA. 2005;293:681-689. Available post-embargo at JAMA.com)

Editor's Note: This study was funded by Astra-Zeneca. For financial disclosure information, please see the JAMA article.

Ximelagatran Proves as Effective, Simpler, Than Warfarin for Preventing Stroke in Patients with Atrial Fibrillation

In a second study in this week's JAMA, Jonathan L. Halperin, M.D., of Mount Sinai
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Contact: Bruce L. Davidson, M.D.
206-215-2500
JAMA and Archives Journals
8-Feb-2005

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