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Use of new direct thrombin inhibitor may be as effective as current standard treatment

(San Diego, Calif., December 7, 2003) The use of ximelagatran in patients with acute venous thromboembolism is as safe and effective as the current standard treatment of enoxaparin, according to a study presented today during the 45th Annual Meeting of the American Society of Hematology (ASH). Ximelagatran is a novel oral direct thrombin inhibitor that, in its activated form, selectively inhibits free and clot-bound thrombin, a key enzyme in the body's coagulation pathway.

"We believe that ximelagatran holds promise as a new agent for the treatment of venous thromboembolism, a sometimes fatal disease that affects an estimated 250,000 to two million Americans a year," said Charles Francis, M.D., of the University of Rochester, Rochester, N.Y., presenting author of the study. "Further studies are needed to confirm its effectiveness over currently available treatments."

Researchers of this international, double-blind, double-dummy study (known as the Thrive Treatment Study) randomized 2,489 patients to either ximelagatran (36 mg twice a day) for six months (1,240 patients) or enoxaparin (1 mg/kg twice a day) for a minimum of five days followed by warfarin (target INR 2.0 to 3.0) for six months (1,249 patients). All participants, 53 percent of whom were men, had acute deep vein thrombosis and 37 percent had confirmed pulmonary embolism.

During six months of treatment, oral ximelagatran was as effective as enoxaparin/warfarin in preventing recurrent venous thromboembolism in patients with acute deep vein thrombosis, 2.1 percent versus 2.0 percent, respectively. Ximelagatran also was associated with a favorable outcome with respect to major bleeding (1.3 percent versus 2.2 percent) and mortality rates (2.3 percent versus 3.4 percent). Laboratory evaluation showed an incidence of serum alanine aminotransferase (ALAT, commonly measured to assess liver function) elevations of 9.6 percent, which is greater than three times the upper lim
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Contact: Aimee Frank
amf@spectrumscience.com
202-955-6222
American Society of Hematology
7-Dec-2003


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