Anticoagulation without monitoring?

Dabigatran is an oral direct thrombin inhibitor, currently being used in many countries as an alternative to warfarin. It is anxiously awaited in this country primarily because, unlike warfarin, it does not require monitoring with blood tests. The drug has been shown to be as effective as warfarin in preventing stroke in patients with atrial fibrillation (N Engl J Med 2009;361:1139-1151).

A new study published in December 2009 compares the two drugs in the treatment of acute venous thromboembolism. In a randomized, double-blind, non-inferiority trial, patients with acute venous thrombus embolism were given a median of 9 days of parenteral anticoagulation therapy, then were randomized to oral dabigatran (150 mg twice a day) or warfarin that was dose-adjusted to achieve an INR of 2.0-3.0. The primary outcome was 6-month incidence of recurrent symptomatic, objectively confirmed venous thromboembolism and related deaths. Of the patients randomized to receive dabigatran, 2.4% had recurrent venous thromboembolism compared to 2.1% of patients on warfarin (difference in risk of 0.4%; 95% confidence interval [CI], -0.8 to 1.5; P < 0.001 for the prespecified non-inferiority margin). Major bleeding episodes occurred in 1.6% of patients on dabigatran vs 1.9% of patients on warfarin. Episodes of any bleeding were 16.1% with dabigatran and 21.9% with warfarin. There was no difference in the number of deaths, acute coronary syndromes, or abnormal liver function tests between the two groups. Treatment was discontinued due to adverse events in 9% of patients on dabigatran and 6.8% of patients on warfarin. The authors concluded that for treatment of acute venous thromboembolism, a fixed dose of dabigatran is as effective as warfarin, has similar safety, but does not require laboratory monitoring (N Engl J Med 2009;361:2342-2352).

Physicians and patients alike in the United States have been awaiting an orally effective anticoagulant that doesn't require monitoring. Dabigatran, a direct thrombin inhibitor, may soon fill that role. The drug, which has the additional advantage of having minimal drug and food interactions, has been available in Canada and Europe for almost 2 years, and with the completion of Phase 3 trials such as this one, there is speculation the FDA may take action this year.