Determinants of label non-adherence to non-vitamin K oral anticoagulants in patients with newly diagnosed atrial fibrillation
Seelig, J; Trinks-Roerdink, E M; Chu, G; Pisters, R; Theunissen, Ljhj; Trines, S A; Pos, L; Kirchhof, Cjhj; de Jong, Sfams; den Hartog, F R; van Alem, A P; Polak, P E; Tieleman, R G; van der Voort, P H; Lenderink, T; Otten, A M; de Jong, Jssg; Gu, Y L; Luermans, Jglm; Kruip, Mjha; Timmer, Saj; de Vries, Tac; Cate, H Ten; Geersing, G J; Rutten, F H; Huisman, M V; Hemels, Mew
(2022) European heart journal open, volume 2, issue 3
(Article)
Abstract
Aims To evaluate the extent and determinants of off-label non-vitamin K oral anticoagulant (NOAC) dosing in newly diagnosed Dutch AF patients. Methods In the DUTCH-AF registry, patients with newly diagnosed AF (,6 months) are prospectively enrolled. Label adherence and results to NOAC dosing was assessed using the European Medicines Agency
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labelling. Factors associated with off-label dosing were explored by multivariable logistic regression analyses. From July 2018 to November 2020, 4500 patients were registered. The mean age was 69.6 + 10.5 years, and 41.5% were female. Of the 3252 patients in which NOAC label adherence could be assessed, underdosing and overdosing were observed in 4.2% and 2.4%, respectively. In 2916 (89.7%) patients with a full-dose NOAC recommendation, 4.6% were underdosed, with a similar distribution between NOACs. Independent determinants (with 95% confidence interval) were higher age [odds ratio (OR): 1.01 per year, 1.01–1.02], lower renal function (OR: 0.96 per ml/min/1.73 m 2, 0.92–0.98), lower weight (OR: 0.98 per kg, 0.97–1.00), active malignancy (OR: 2.46, 1.19–5.09), anaemia (OR: 1.73, 1.08–2.76), and concomitant use of antiplatelets (OR: 4.93, 2.57–9.46). In the 336 (10.3%) patients with a reduced dose NOAC recommendation, 22.9% were overdosed, most often with rivaroxaban. Independent determinants were lower age (OR: 0.92 per year, 0.88–0.96) and lower renal function (OR: 0.98 per ml/min/1.73 m 2, 0.96–1.00). Conclusion In newly diagnosed Dutch AF patients, off-label dosing of NOACs was seen in only 6.6% of patients, most often underdosing. In this study, determinants of off-label dosing were age, renal function, weight, anaemia, active malignancy, and concomitant use of antiplatelets.
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Keywords: Anticoagulants, Atrial fibrillation, Off-label use, Prospective studies, Registries, Cardiology and Cardiovascular Medicine, Surgery
ISSN: 2752-4191
Publisher: Oxford University Press
Note: Funding Information: This work was supported by a research grant from The Netherlands Organization for Health Research and Development (ZonMW) (project numbers 848050006, 848050007). Publisher Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.
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