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New Study Results Published in the New England Journal of Medicine Show Dabigatran Etexilate Mesylate Reduces the Risk of Recurrent Venous Thromboembolism
Date:2/20/2013

ative risk reduction 46 percent; p<0.001)
  • Trend toward lower risk of major bleeding alone: 13 patients, 0.9 percent versus 25 patients,1.8 percent (relative risk reduction 48 percent; p=0.06)
  • A higher rate of acute coronary syndrome (ACS) events was observed in the dabigatran group versus warfarin (13 patients, 0.9 percent versus three patients, 0.2 percent, respectively; p=0.02)
  • RE-SONATE

    • Design: 1,343 patients randomized to dabigatran 150 mg (681 patients) or placebo (662 patients) for six months with extended follow-up to evaluate the long-term risk of recurrence (12 months after completion of study treatment)
    • Efficacy: 92 percent risk reduction for recurrent or fatal VTE with dabigatran versus placebo (three patients, 0.4 percent versus 37 patients, 5.6 percent; p<0.001 for superiority)
    • Safety: the incidence of major bleeding was two patients in the dabigatran group versus zero patients in the placebo group. A higher rate of major or clinically relevant bleeding in the dabigatran group versus no treatment was observed (36 patients, 5.3 percent versus 12 patients, 1.8 percent; p=0.001)

    * Pradaxa® (dabigatran etexilate mesylate) capsules are not approved by the U.S. Food and Drug Administration for the prevention of recurrent VTE or the treatment of acute VTE.

    About Pradaxa® (dabigatran etexilate mesylate) Capsules

    Indications and Usage
    Pradaxa® (dabigatran etexilate mesylate) capsules is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

    IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

    CONTRAINDICATIONS
    PRADAXA is contraindicated in patients with:

    • Active pathological bleeding
    • A known serious hypersensitivity rea
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    SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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    All rights reserved

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