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Extended-use dabigatran effective for VTE

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Two complementary randomized trials — RE-MEDY and RE-SONATE — demonstrate the effectiveness of extended use of dabigatran for the treatment of venous thromboembolism.

Dabigatran (Pradaxa, Boehringer Ingelheim) was associated with lower risk for major or clinically relevant bleeding when compared with warfarin (Coumadin, Bristol-Myers Squibb), but higher risk when compared with placebo, according to research in The New England Journal of Medicine.

RE-MEDY results

RE-MEDY was an active-control, double blind, randomized study that compared dabigatran 150 mg twice daily with warfarin in 2,866 patients with venous thromboembolism (VTE) from July 2006 through July 2010. Patients had completed at least three initial months of therapy.

Researchers reported that 1.8% of patients in the dabigatran group experienced recurrent VTE compared with 1.3% of patients with the warfarin group (HR=1.44 with dabigatran; 95% CI, 0.78-2.64).

Major bleeding was experienced by 0.9% of the dabigatran group vs. 1.8% of the warfarin group (HR=0.52; 95% CI, 0.27-1.02). The dabigatran group also had less frequent major or clinically relevant bleeding (HR=0.54; 95% CI, 0.41-0.71).

In other results, dabigatran was associated with more ACS compared with warfarin (0.9% vs. 0.2%; P=.02).

RE-SONATE results

The placebo-control, double blind, randomized RE-SONATE trial included 1,353 patients with VTE. From November 2007 to September 2010, patients were randomly assigned to dabigatran 150 mg twice daily or placebo. Patients in this study also completed at least three initial months of therapy.

Researchers reported a higher incidence of recurrent VTE in the placebo group compared with the dabigatran group (5.6% vs. 0.4%; HR=0.08; 95% CI, 0.02-0.25).

No major bleeding was reported in the placebo group, but occurred in 0.3% of the dabigatran group. Major or clinically relevant bleeding was also higher in the dabigatran group (5.3% vs. 1.8%; HR=2.92; 95% CI, 1.52-5.6).

One patient in each group experienced ACS.

For more information:

Schulman S. N Engl J Med. 2013;368:709-718.

Disclosure: The studies were funded by Boehringer Ingelheim.