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ASH: Dabigatran, Warfarin Compared for VTE Prevention

Thrombin inhibitor dabigatran found to be safe alternative to warfarin without lab monitoring

MONDAY, Dec. 7 (HealthDay News) -- The oral thrombin inhibitor dabigatran performed similarly to the anticoagulant warfarin to prevent the recurrence of venous thromboembolism (VTE) without the need for constant laboratory monitoring, according to research published online Dec. 6 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 5 to 8 in New Orleans.

Sam Schulman, M.D., of McMaster University in Hamilton, Canada, and colleagues randomized patients with acute VTE to treatment with oral dabigatran (150 mg twice daily) or with warfarin (dose adjusted). The primary study outcome was recurrence of VTE within six months, and VTE-related mortality. End points for safety were major bleeding, acute coronary syndrome, unfavorable liver tests and adverse events.

Among the subjects receiving dabigatran, the researchers found that 2.4 percent had recurrent VTE during the study period, compared to 2.1 percent in the warfarin group. Mortality was similar in both groups, as were acute coronary syndrome events and unfavorable liver tests. Major bleeding events occurred in 1.6 and 1.9 percent of the dabigatran and warfarin groups, respectively. Bleeding episodes of any degree were observed in 16.1 percent of subjects on dabigatran and 21.9 percent of subjects on warfarin.

"For patients and health care providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs and therefore does not require routine blood-coagulation testing," the authors write.

Several authors reported receiving lecture and consulting fees, or grant support from pharmaceutical companies.

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