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Ximelagatran is an orally administered, fixed-dose, direct thrombin inhibitor that does not require monitoring. It is effective for prevention and treatment of deep-vein thrombosis (DVT), and for prevention of stroke in atrial fibrillation patients, but concerns remain about hepatic toxicity. In two new randomized trials, sponsored by the drug's manufacturer, researchers explored ximelagatran's efficacy and risk.
In the first trial, 2489 patients with DVT received ximelagatran (36 mg twice daily without monitoring or dose adjustment) or subcutaneous enoxaparin followed by warfarin. During an average follow-up of about 5 months, rates of recurrent DVT and rates of major bleeding were similar in both groups. Risk for elevated serum alanine ami…