In the first study, Jean-Noel Fiessinger, M.D., of Hpital Europen Georges Pompidou, Paris, and colleagues conducted a study of patients with deep vein thrombosis (blood clot in veins of the legs, pelvis or arms) to determine the efficacy and safety of oral ximelagatran compared to standard treatment with the anticoagulants enoxaparin and warfarin.
According to background information in the article, current therapy for patients with acute venous thromboembolism consists of 5 to 7 days of the anticoagulant heparin overlapped with and followed by long-term, oral anticoagulation with a therapy such as warfarin. Heparin must be given parenterally (by injection, usually through the veins) and administration requires considerable health care resources. Warfarin is given orally, but has an unpredictable dose response, interacts with many drugs, and can be affected by changes in diet; thus, continued coagulation monitoring and dose adjustment are necessary. Ximelagatran is administered orally and is rapidly absorbed and quickly converted to its active form.
The trial (Thrombin Inhibitor in Venous Thromboembolism [THRIVE] Treatment Study) included 2,489 patients with deep vein thrombosis. The study was conducted at 279 centers in 28 countries from September 2000 through December 2002. Patients were randomized to receive 6 months of treatment with either oral ximelagatran, twice daily, or subcutaneous enoxaparin, twice daily for 5 to 20 days followed by warfarin.
The researchers found that the primary efficacy end point of recurrent venous thromboe
Contact: Bruce L. Davidson, M.D.
JAMA and Archives Journals