Antidote for Pradaxa Demonstrates Efficacy in Study

Boehringer Ingelheim announced results demonstrating that its investigational fully humanized antibody fragment (Fab) rapidly reversed the anticoagulation effect of dabigatran in healthy male volunteers.

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Researchers evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of the Fab in this randomized, double-blind, placebo-controlled study with 145 healthy male volunteers. In part one of the study, subjects received single, progressively increasing intravenous doses of up to 8g of the Fab. In part two, the potential for reversal of dabigatran-induced anticoagulation was evaluated, with 5-minute intravenous infusions using doses of 1g, 2g and 4g following pre-treatment with dabigatran 220mg twice-daily for 3 days.

The anticoagulant effect of dabigatran and its reversal were assessed using diluted thrombin time (Hemoclot DTI assay), thrombin time (TT), activated partial thromboplastin time (aPTT), ecarin clotting time (ECT) and activated clotting time (ACT). Dabigatran prolonged clotting times of all coagulation markers.

Results of the study showed:

  • The on-set of action of the antidote was detected immediately following a 5-minute infusion
  • Thrombin time, which is a measurement of the time it takes for a clot to form in a blood sample and the most sensitive indicator of dabigatran’s anticoagulant effect, was reversed with the Fab 
  • With this assay, reversal of the anticoagulation effect was complete and sustained in 7 of 9 subjects who received the 2g dose and in 8 out of 8 subjects who received the 4g dose
  • The 1g dose resulted in complete reversal of anticoagulation effect; however, after approximately 30 minutes there was some return of the anticoagulation effects of dabigatran

Currently, there are no specific antidotes for new oral anticoagulants available to complement the existing range of bleed management options during critical care situations.

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

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