Global Use of Idarucizumab in Clinical Practice: Outcomes of the RE-VECTO Surveillance Program.

Fanikos, John, Murwin, Debra, Gruenenfelder, Fredrik, Tartakovsky, Igor, França, Lionel Riou, Reilly, Paul A, Kermer, Pawel, Wowern, Fredrik von, Lane, Deirdre A ORCID: 0000-0002-5604-9378 and Butcher, Ken (2020) Global Use of Idarucizumab in Clinical Practice: Outcomes of the RE-VECTO Surveillance Program. Thrombosis and haemostasis, 120 (1). pp. 27-35.

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Official URL: http://dx.doi.org/10.1055/s-0039-1695771

Abstract

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.

Item Type:	Article
Uncontrolled Keywords:	anticoagulation, idarucizumab, dabigatran etexilate, real-world utilization, reversal agent
Depositing User:	Symplectic Admin
Date Deposited:	29 Jan 2020 08:22
Last Modified:	19 Jan 2023 00:06
DOI:	10.1055/s-0039-1695771
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3072306