New Drug Idarucizumab First To Reverse Anticoagulant Dabigatran

MedicalResearch.com Interview with:
Dr. Stephan Glund Ph.D.

Boehringer Ingelheim Pharma GmbH & Co. KG
Transl. Medicine & Clin. Pharmacology

Medical Research: What is the background for this study? What are the main findings?

Dr. Glund: There are currently no specific reversal agents available for any of the non-Vitamin K antagonist oral anticoagulants (NOACs). We are working on the development of idarucizumab, a specific reversal agent to dabigatran, the first approved NOAC. The study now published in The Lancet investigated, for the first time in healthy volunteers, the reversal of the anticoagulant effect of dabigatran by idarucizumab.

Our study in healthy male volunteers showed that idarucizumab led to immediate, complete and sustained reversal of the anticoagulant effect of dabigatran. Participants first received dabigatran and then idarucizumab. The specific reversal agent was given two hours after the last dose of dabigatran, when dabigatran concentrations were at peak levels. After a five-minute infusion of idarucizumab, anticoagulation was immediately reversed back to baseline levels. The reversal effect was sustained for more than 24 hours for all doses of 2g and above. Idarucizumab was well tolerated by the study participants.

In addition, our study also showed that administration of idarucizumab reversed dabigatran-induced inhibition of wound-site fibrin formation, which plays a key role in the blood clotting mechanism. This suggests that idarucizumab might also reverse impaired haemostasis due to dabigatran anticoagulation at a wound site.

Medical Research: What should clinicians and patients take away from your report?

Dr. Glund: The data now published in The Lancet show in an impressive manner how effective idarucizumab was for reversing dabigatran in healthy volunteers. This supports the specific reversal agent as a highly targeted treatment option if reversal of the anticoagulant effect is needed, e.g. for urgent interventions.

But as the current study was conducted in healthy young volunteers, further efficacy and safety testing is of course required and actually ongoing.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Glund: The clinical study programme for idarucizumab is ongoing. In 2014, Boehringer Ingelheim has initiated RE-VERSE AD™, a global Phase III patient study to investigate idarucizumab in emergency settings. Up to 300 patients taking dabigatran, aged 18 years or over are expected to be enrolled from more than 400 centres in 38 countries worldwide. This is the first study in patients investigating a specific reversal agent under development for a non-Vitamin K antagonist oral anticoagulant.

Citation:

Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial

Glund, Stephan et al.

The Lancet Published Online: 15 June 2015

DOI: http://dx.doi.org/10.1016/S0140-6736(15)60732-2

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Dr. Stephan Glund Ph.D., Boehringer Ingelheim Pharma GmbH & Co. KG, & Transl. Medicine & Clin. Pharmacology (2015). New Drug Idarucizumab First To Reverse Anticoagulant Dabigatran 

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