Carries lower risk of major, clinically relevant bleeding than warfarin; higher risk than placebo
THURSDAY, Feb. 21 (HealthDay News) -- For patients with venous thromboembolism, extended treatment with dabigatran is noninferior to warfarin, according to a study published in the Feb. 21 issue of the New England Journal of Medicine.
Sam Schulman, M.D., Ph.D., from McMaster University in Hamilton, Canada, and colleagues compared dabigatran (150 mg twice daily) with warfarin (active-control study) or with placebo (placebo-control study) for patients with venous thromboembolism who had completed initial treatment of at least three months.
The researchers found that in the active-control study, recurrent venous thromboembolism occurred in 1.8 percent of the 1,430 dabigatran-treated patients and in 1.3 percent of the 1,426 warfarin-treated patients (P = 0.01 for noninferiority). Major bleeding occurred in 0.9 and 1.8 percent of patients in the dabigatran and warfarin groups, respectively (hazard ratio [HR], 0.52; 95 percent confidence interval, 0.27 to 1.02), while the frequency of major or clinically relevant bleeding was significantly less in the dabigatran group (HR, 0.54). In the placebo-control study, recurrent venous thromboembolism occurred in 0.4 percent of the 681 dabigatran-treated patients and in 5.6 percent of the 662 placebo-treated patients (HR, 0.08; P < 0.001). Two patients (0.3 percent) in the dabigatran group and none in the placebo group experienced major bleeding, while major or clinically relevant bleeding occurred in 5.3 and 1.8 percent, respectively (HR, 2.92).
"Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo," write the authors.
The study was funded by Boehringer Ingelheim.
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