Brigham and Women's Hospital, Boston, Massachusetts, United States.
Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, United States.
Thromb Haemost. 2020 Jan;120(1):27-35. doi: 10.1055/s-0039-1695771. Epub 2019 Aug 30.
Idarucizumab was approved for the reversal of dabigatran in 2015. We investigated whether postapproval usage patterns of idarucizumab in a real-world setting reflect those observed in the pivotal trials. No safety or efficacy data were collected in this medical record-based observational study. RE-VECTO, a global postapproval, international, surveillance program, involved hospital pharmacies in countries where idarucizumab was licensed and dispensed (August 2016-June 2018). Characteristics of sites prescribing idarucizumab and of eligible patients (≥ 18 years old and receiving idarucizumab regardless of prior oral anticoagulant use), as well as idarucizumab utilization data, were collected and analyzed descriptively. Sixty-one sites enrolled 359 patients. Most pharmacies (85.2%) were centralized, and the median idarucizumab units stocked per hospital was 2.0 (interquartile range, 1.0-3.0). Almost three-quarters of patients were elderly (74.9% aged > 70 years), and only four (1.1%) had received idarucizumab before. Nearly all patients were treated with dabigatran (97.5%). There was a low frequency of unapproved dabigatran dosage regimens (3.3%). Life-threatening or uncontrolled bleeding was the most frequent indication for idarucizumab (57.7%), followed by emergency surgery/urgent procedure (35.9%). Of the life-threatening bleeding events, the most frequent were gastrointestinal tract (44.4%) and intracranial (38.6%). Most patients (95.0%) were given the full dose of two vials (2 × 2.5 g) of idarucizumab initially, and very few (1.7%) received a second dose. Of those patients requiring emergency or scheduled/planned surgery/procedures, 25.5% underwent gastrointestinal and/or abdominal surgery/procedures. Real-world usage patterns of idarucizumab provide valuable insights into emergency reversal strategies. Off-label use was minimal.
依达鲁单抗于 2015 年被批准用于达比加群的逆转。我们研究了在真实环境中依达鲁单抗的使用模式是否反映了关键性试验中的观察结果。本基于病历的观察性研究未收集安全性或疗效数据。RE-VECTO 是一项全球性的上市后、国际性的监测计划，涉及到依达鲁单抗获得许可和配发的国家的医院药房（2016 年 8 月至 2018 年 6 月）。描述性地收集了开具依达鲁单抗的地点特征和符合条件的患者（≥18 岁，无论先前是否使用口服抗凝剂，均接受依达鲁单抗治疗），以及依达鲁单抗的使用数据。61 个地点纳入了 359 名患者。大多数药房（85.2%）为集中式药房，每家医院储存的依达鲁单抗单位中位数为 2.0（四分位间距，1.0-3.0）。近 3/4 的患者为老年人（74.9%年龄>70 岁），仅有 4 人（1.1%）之前接受过依达鲁单抗治疗。几乎所有患者均接受达比加群治疗（97.5%）。未批准的达比加群剂量方案频率较低（3.3%）。危及生命或无法控制的出血是使用依达鲁单抗的最常见指征（57.7%），其次是紧急手术/紧急手术（35.9%）。危及生命的出血事件中，最常见的是胃肠道（44.4%）和颅内（38.6%）。大多数患者（95.0%）最初接受了两剂（2×2.5g）依达鲁单抗的全剂量，极少数患者（1.7%）接受了第二剂。在需要紧急或计划/预定手术/程序的患者中，25.5%接受了胃肠道和/或腹部手术/程序。依达鲁单抗的实际使用模式为紧急逆转策略提供了有价值的见解。超适应证使用很少见。
