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Study Results Reinforce Safety, Efficacy of Pradaxa Reversal Agent
Idarucizumab (Praxbind) immediately reversed the anticoagulant effect of dabigatran etexilate mesylate (Pradaxa) in patients in emergency situations, the final results of the RE-VERSE AD study confirm. The effects were consistent both in patients requiring an urgent surgery or intervention and in patients presenting with uncontrollable or life-threatening bleeding.
Idarucizumab is the only approved specific reversal agent for a novel oral anticoagulant. Both drugs are marketed by Boehringer Ingelheim.
The findings were presented at the International Society on Thrombosis and Haemostasis 26th Biennial Congress in Berlin, Germany, and were simultaneously published in the New England Journal of Medicine. The study noted that the reversal of the anticoagulant effect of Pradaxa allowed physicians to quickly initiate necessary emergency interventions.
The primary endpoint of RE-VERSE AD—reversal of the anticoagulant effect of Pradaxa within four hours as measured by diluted thrombin time and ecarin clotting time—was observed in 100%of patients (95% confidence interval, 100–100). Reversal became evident immediately after administration of idarucizumab and was maintained for 24 hours in most patients. Reversal was independent of age, sex, kidney function, or dabigatran concentration at baseline. A single 5 g dose of idarucizumab was sufficient in 98% of patients.
The clinical outcomes captured as secondary endpoints provide insights into the clinical relevance of anticoagulation reversal: in patients enrolled with acute bleeding (Group A), who could be assessed for time to cessation of bleeding, it took a median of 2.5 hours until the bleeding had stopped; in patients enrolled with a need for urgent surgery or intervention (Group B), the required procedures could be initiated after a median of 1.6 hours. In 93.4% of patients requiring procedures, hemostasis during the procedure was described as normal.
No adverse safety signals related to idarucizumab were observed in the study. Patients in this study were elderly, had numerous comorbidities, and presented with serious index events, such as intracranial hemorrhage, multiple trauma, or sepsis. Mortality rates at 90 days were 18.8% (Group A) and 18.9% (Group B). At 90 days, thrombotic events had occurred in 6.3% of Group A patients and 7.4% of Group B patients, which is consistent with rates reported after major surgical procedures or hospitalization for uncontrolled bleeding.
Source: Boehringer Ingelheim Pharmaceuticals; July 11, 2017.