Key result
In a real-world setting of 262 Japanese patients, idarucizumab administration resulted in adverse drug reactions in 6.9% of patients and achieved a median maximum percentage reversal of dabigatran's anticoagulant effect of 100%.
Why the study?
Post-marketing surveillance was conducted to collect safety and efficacy data on idarucizumab following its September 2016 approval in Japan for dabigatran reversal.
Does idarucizumab safely and effectively reverse the anticoagulant effects of dabigatran in Japanese patients with serious bleeding or requiring urgent procedures?
Observational (n=262)
Open-label
Yes
Does idarucizumab safely and effectively reverse the anticoagulant effects of dabigatran in Japanese patients with serious bleeding or requiring urgent procedures?
In a real-world Japanese post-marketing surveillance study, idarucizumab safely and effectively reversed the anticoagulant effects of dabigatran.
Supports idarucizumab for dabigatran reversal in Japanese patients; extends evidence but remains hypothesis-generating.
INTRODUCTION: Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran, and it was approved in Japan in September 2016. An all-case post-marketing surveillance is ongoing to collect data in Japanese patients treated with idarucizumab who had serious bleeding (Group A) or required an urgent procedure (Group B). METHODS: The primary endpoint was the incidence of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effect of dabigatran based on activated partial thromboplastin time (aPTT) within 4 h after idarucizumab administration. RESULTS: This interim analysis included 262 patients who received idarucizumab. Eighteen patients (6.9%) experienced ADRs within 4 weeks. The reversal effect of idarucizumab based on aPTT within 4 h after idarucizumab administration was assessed in 30 patients and the median maximum percentage reversal was 100%. In Group A, the median time to bleeding cessation in patients without intracranial bleeding was 3.3 h. In Group B, normal intraoperative hemostasis was reported in 63 patients (72.4%). CONCLUSIONS: The results of this interim analysis suggest that idarucizumab is safe and effective for the reversal of dabigatran in Japanese patients in a real-world setting, and support the continued use of idarucizumab. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02946931.
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Yasaka et al. (2020) conducted an observational in Dabigatran-treated patients with life-threatening bleeding or requiring urgent surgery (n=262). Idarucizumab was evaluated on Incidence of adverse drug reactions (ADRs) within 4 weeks. In a real-world setting of 262 Japanese patients, idarucizumab administration resulted in adverse drug reactions in 6.9% of patients and achieved a median maximum percentage reversal of dabigatran's anticoagulant effect of 100%.
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