ArticleCardiology and therapy2023
Idarucizumab for Emergency Reversal of the Anticoagulant Effects of Dabigatran: Final Results of a Japanese Postmarketing Surveillance Study.
Article in Cardiology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02946931 (The Drug Use-results Survey), which is not on this map. Cited by 7 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan
Who cites it
7 citing papers in PubMed, 6 citations in OpenAlex.
- Characteristics of Intracranial Hemorrhage in Patients on Factor-Xa Inhibitors: Japan Stroke Data Bank.Internal medicine (Tokyo, Japan) · 2026Article
- Current Status of the Safety and Efficacy of Antidotes for Direct Oral Anticoagulants in Japan.JACC. Asia · 2026Article
- Specific reversal agents for direct oral anticoagulants in neurosurgical emergencies - a systematic review.Research and practice in thrombosis and haemostasis · 2025Review
- A Saudi Heart Association Position Statement on the use of DOACs in Patients With Arterial and Venous Thrombosis.Journal of the Saudi Heart Association · 2025Article
- Unified Methodology for the Primary Preclinical In Vivo Screening of New Anticoagulant Pharmaceutical Agents from Hematophagous Organisms.International journal of molecular sciences · 2024Article
- Real-World Safety and Effectiveness of a 4-Factor Prothrombin Complex Concentrate in Japanese Patients Experiencing Major Bleeding: A Post-marketing Surveillance Study.Cardiology and therapy · 2024Article
- Idarucizumab in dabigatran-treated patients with acute stroke: a review and clinical update.Frontiers in neurology · 2024Review
Corrections and comments
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Authors and funding
8 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIdarucizumab, a monoclonal antibody fragment that rapidly reverses the anticoagulant effects of dabigatran, was approved in Japan in September 2016, at which time an all-case, postmarketing surveillance (PMS) study was initiated to collect data on idarucizumab in Japanese patients. Interim results were published previously, and the final results are reported herein.
methodsThis multicenter, open-label, uncontrolled, non-interventional PMS study was conducted in Japanese patients who received idarucizumab at the approved dose (2 × 2.5 g/50 ml) and had uncontrolled bleeding (group A) or required an emergency procedure (group B). The primary endpoint was the frequency of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effects of dabigatran, within 4 h of idarucizumab administration, based on activated partial thromboplastin time (aPTT).
resultsThe final analysis included 804 patients. ADRs during the idarucizumab treatment and post-treatment periods were reported in 17 of 542 patients (3.1%) in group A and 12 of 240 patients (5.0%) in group B. Thrombotic events were reported in 22 patients (4.1%) in group A and 15 patients (6.3%) in group B, and hypersensitivity occurred in four (0.7%) and five patients (2.1%), respectively. Among 793 patients evaluated for effectiveness, 78 in group A and 26 in group B had aPTT data at baseline (immediately before idarucizumab administration) and within 4 h of idarucizumab administration; in these patients, median maximum percentage reversal within 4 h of idarucizumab administration was 100%.
conclusionsThe final analysis from the PMS study confirms previous findings suggesting that idarucizumab can safely and effectively reverse the anticoagulant effects of dabigatran in Japanese patients in clinical practice. The results support the continued use of idarucizumab in Japan.
trial registrationThis study is registered with ClinicalTrials.gov (NCT02946931).
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