First patient study data show that idarucizumab reverses dabigatran within minutes
Posted: 22 June 2015 |
Results from an interim analysis of a Phase III study demonstrate that idarucizumab immediately reversed the anticoagulant effect of dabigatran…
Results from an interim analysis of Boehringer Ingelheim’s Phase III RE-VERSE AD patient study demonstrate that 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran (Pradaxa) in patients requiring urgent anticoagulant reversal.
The results were presented at the International Society of Thrombosis and Haemostasis 2015 Congress.
“The interim analysis from RE-VERSE AD is important for healthcare professionals as it provides the first insights into the effect of a specific reversal agent to a non-vitamin K antagonist oral anticoagulant during real-world emergency situations,” said Dr Charles Pollack, Professor of Emergency Medicine at the Perelman School of Medicine, University of Pennsylvania in Philadelphia, USA, and lead investigator of the patient study. “As observed in earlier research in volunteers, idarucizumab reversed the anticoagulant effect of dabigatran in patients completely within minutes, even in those rare critical care situations studied in RE-VERSE AD. These data demonstrate that use of idarucizumab can help physicians focus on other vital aspects of emergency management beyond anticoagulant reversal in dabigatran-treated patients.”
In the study, patients were categorised into two groups – (A) patients with uncontrolled or life-threatening bleeding complications, e.g. intracranial haemorrhage or severe trauma after a car accident (Group A, n= 51), or (B) patients requiring emergency surgery or an invasive procedure, e.g. surgery for an open fracture after a fall (Group B, n=39). The primary endpoint of the study is the degree of reversal of the anticoagulant effect of dabigatran achieved by 5 g idarucizumab within 4 hours measured by diluted thrombin time (dTT) and ecarin clotting time (ECT).
The study of idarucizumab is ongoing
The interim analysis from RE-VERSE AD included data from 90 patients in emergency settings who were taking dabigatran and required reversal. Of the 81 patients that presented with elevated anticoagulation levels at baseline as measured with ECT, results showed:
- The study met its primary endpoint, achieving 100%maximum reversal as median value across all patients
- Reversal was evident immediately after administration of the first vial of idarucizumab and was complete in all but 1 patient
- After 4 and 12 hours, laboratory tests showed normal coagulation levels in almost 90% of patients
- Normal blood clotting (haemostasis) during surgery was reported in 92% of the patients that required surgery or invasive procedures
- There was no signal of a pro-coagulant effect following administration of idarucizumab
- Thrombotic events occurred in five patients
- There were 18 deaths overall.
Professor Jörg Kreuzer, Vice President Medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim , said, “The study is ongoing. We look forward to gaining further understanding of the potential of idarucizumab as yet another breakthrough in anticoagulant therapy for advancing care of patients who require urgent reversal of the anticoagulant effect of dabigatran.”