Secondary Prevention of Venous Thromboembolism with the Oral Direct Thrombin Inhibitor Ximelagatran

Abstract

The authors conducted a study to determine the effects of oral ximelagatran for the extended prevention of venous thromboembolism because the protection of anticoagulation therapy does not extend beyond six months owing to the risk of major bleeding. Patients with venous thromboembolism who had undergone six months of anticoagulant therapy were randomized to treatment with 24 mg ximelagatran (twice daily) (612 patients) or placebo (611 patients). The regimen lasted 18 months during which time coagulation was not monitored. Symptomatic recurrent venous thromboembolism occurred in 12 patients on the ximelagatran regimen and 71 patients in placebo. In the ximelagatran group, 6.4% of patients had transient elevation of alanine aminotransferase level to more than three times compared with 1.2% in the placebo group. The authors concluded that oral ximelagatran was superior to placebo for the extended prevention of venous thromboembolism.