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Coumarin-derived drugs such as warfarin have been the mainstay of oral anticoagulant treatment for decades. However, they are slow-acting, are teratogenic, and have a narrow therapeutic index that necessitates frequent monitoring. An oral thrombin inhibitor, ximelagatran, was derailed in development because of unacceptable hepatotoxicity. Now, another oral thrombin inhibitor, dabigatran etexilate, is on the threshold of regulatory approval. It has a rapid onset of action, requires only once-daily dosing, and has predictable activity so that monitoring is not required.
Investigators from several European university centers (and some employed by dabigatran’s manufacturer) examined the safety and effectiveness of this drug for preventing venous…