Idarucizumab for Reversal of Dabigatran-Associated Anticoagulation

Abstract

Objective: To review clinical data on idarucizumab for the reversal of dabigatran-associated anticoagulation. Data Sources: Articles for this review were identified via PubMed using the MeSH term dabigatran combined with the keyword idarucizumab. Additional online searches via PubMed and Google Scholar were conducted for both prescribing and cost information. Study Selection and Data Extraction: English-language clinical trials published between 1946 and May 2016 were included for review. Bibliographies of selected articles were also manually reviewed for relevant publications that focused on reversal strategies for dabigatran-associated anticoagulation. Data Synthesis: The safety and tolerability of idarucizumab has been evaluated in 3 phase I clinical trials. The use of idarucizumab for reversing dabigatran-associated anticoagulation is also being evaluated in the phase III RE-VERSE AD study. Interim results of the RE-VERSE AD study have been published. Conclusions: Idarucizumab rapidly neutralizes the anticoagulant effect of dabigatran in healthy volunteers, in patients with life-threatening bleeding, and in patients requiring urgent surgery that cannot be delayed. These observations are largely based on laboratory assessments rather than clinical outcomes. Idarucizumab is well tolerated, and it does not appear to induce procoagulant or immunogenic adverse effects.