Investigational drug reverses anticoagulant effect of dabigatran in minutes: Study

Use of investigational reversal agent idarucizumab can allow physicians to focus on other vital aspects of emergency management beyond anticoagulant reversal in dabigatran-treated patients, according to a study published in the New England Journal of Medicine.

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The data was also presented as a late-breaker at the International Society of Thrombosis and Haemostasis 2015 Congress in Toronto, Canada.

Idarucizumab is currently under review by FDA as a specific reversal agent for the anticoagulant effect of dabigatran in patients needing emergency or urgent surgery or procedures, or for life-threatening or uncontrolled bleeding events.

In an interim analysis of the ongoing global phase 3 RE-VERSE A study showed that 5 g of idarucizumab reversed the anticoagulant effect of dabigatran the active ingredient in Pradaxa (dabigatran etexilate mesylate) in patients requiring urgent anticoagulant reversal within minutes. No safety concerns relating to idarucizumab were identified.

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RE-VERSE AD was designed to evaluate the types of patients and real-world situations healthcare professionals may see in the emergency setting, according to lead study author Charles Pollack, professor of emergency medicine at the Perelman School of Medicine of the University of Pennsylvania School of Medicine in Philadelphia.

In the study, patients were categorized into 2 groups: (A) Patients with uncontrolled or life-threatening bleeding complications, eg, intracranial hemorrhage or severe trauma after a car accident (Group A, n= 51), or (B) Patients requiring emergency surgery or an invasive procedure, eg, surgery for an open fracture after a fall or an incarcerated hernia with ischemic bowel (Group B, n=39). The primary end point of the study is the degree of reversal of the anticoagulant effect of dabigatran achieved by 5 g idarucizumab within 4 hours, as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT).

 

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