RE-VERSE AD Endpoints
Blood samples were obtained after the first infusion and then between 10 and 30 minutes and at 1, 2, 4, 12 and 24 hours after the second infusion. The primary endpoint was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours of the second Praxbind infusion. This was based on either the dilute thrombin time or ecarin clotting time. The secondary endpoint was the proportion of patients with normalization of the dilute thrombin time or ecarin clotting time and reduction in the concentration of unbound dabigatran.
RE-VERSE AD Results
Praxbind reversed the anticoagulant activity of dabigatran in 88 to 98% of patients.
Unbound dabigatran stayed below 20 ng/mL at 24 hours in 79% of patients.
Median time to cessation of bleeding was 11.4 hours.
Among 36 patients who underwent a procedure, normal hemostasis was reported in 33 patients.
Potential Impact of Praxbind
Boehringer Ingelheim states, “while we anticipate that Praxbind will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added confidence in choosing Pradaxa”
With FDA approval and the continued emergence of positive outcomes from the RE-VERSE AD trial, prescribers may become more willing to use Pradaxa in the place of warfarin for nonvalvular atrial fibrillation. Praxbind will likely be integrated into various hospital guidelines for pre-operative management of patients taking Pradaxa.
Babilonia K, Trujillo T. The role of prothrombin complex concentrates in the reversal of target specific anticoagulants. Thromb J. 2014;12:8.
Boehringer Ingelheim Press Release – 16 October 2015. FDA Approves Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa (dabigatran etexilate).
Pollack CV, Reilly PA, Eikelboom J et al. Praxbind for Dabigatrin Reversal (RE-VERSE AD) N Eng J of Med 2015; Epub online June 22, 2015