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Tytuł pozycji:

Off-label-dosing of non-vitamin K-dependent oral antagonists in AF patients before and after stroke: results of the prospective multicenter Berlin Atrial Fibrillation Registry.

Tytuł :
Off-label-dosing of non-vitamin K-dependent oral antagonists in AF patients before and after stroke: results of the prospective multicenter Berlin Atrial Fibrillation Registry.
Autorzy :
Tütüncü S; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Olma M; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.; Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Kunze C; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Dietzel J; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Schurig J; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Fiessler C; Institute of Clinical Epidemiology and Biometry, University Würzburg, Würzburg, Germany.
Malsch C; Institute of Clinical Epidemiology and Biometry, University Würzburg, Würzburg, Germany.; Comprehensive Heart Failure Center, Clinical Trial Centre Würzburg, University of Würzburg, University Hospital Würzburg, Würzburg, Germany.
Haas TE; Institute of Clinical Epidemiology and Biometry, University Würzburg, Würzburg, Germany.
Dimitrijeski B; Department of Neurology, Vivantes Klinikum Neukölln, Berlin, Germany.
Doehner W; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.; BCRT-Berlin Institute of Health Center for Regenerative Therapies, and Department of Cardiology (Virchow Klinikum), Charité-Universitätsmedizin Berlin, German Centre for Cardiovascular Research (DZHK), Partner Site Berlin, Berlin, Germany.
Hagemann G; Department of Neurology, Helios Klinik Berlin-Buch, Berlin, Germany.
Hamilton F; Department of Neurology, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany.
Honermann M; Department of Neurology, Vivantes Klinikum Spandau, Berlin, Germany.
Jungehulsing GJ; Department of Neurology, Jüdisches Krankenhaus Berlin, Berlin, Germany.
Kauert A; Department of Neurology, Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany.
Koennecke HC; Department of Neurology, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
Mackert BM; Department of Neurology, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany.
Nabavi D; Department of Neurology, Vivantes Klinikum Neukölln, Berlin, Germany.
Nolte CH; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.; Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.; German Center for Cardiovascular Diseases (DZHK), Partner site Berlin, Berlin, Germany.; Berlin Institute of Health (BIH), Berlin, Germany.
Reis JM; Institute of Clinical Epidemiology and Biometry, University Würzburg, Würzburg, Germany.
Schmehl I; Department of Neurology, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany.
Sparenberg P; Department of Neurology, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany.
Stingele R; Department of Neurology, German Red Cross Hospital Berlin Köpenick, Berlin, Germany.
Völzke E; Department of Neurology, Schlosspark-Klinik Berlin, Berlin, Germany.
Waldschmidt C; Department of Neurology, Vivantes Humboldt-Klinikum, Berlin, Germany.
Zeise-Wehry D; Department of Neurology, Park-Klinik Weissensee, Berlin, Germany.
Heuschmann PU; Institute of Clinical Epidemiology and Biometry, University Würzburg, Würzburg, Germany.; Comprehensive Heart Failure Center, Clinical Trial Centre Würzburg, University of Würzburg, University Hospital Würzburg, Würzburg, Germany.
Endress M; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.; Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.; German Center for Neurodegenerative Diseases (DZNE), Partner site Berlin, Berlin, Germany.; German Center for Cardiovascular Diseases (DZHK), Partner site Berlin, Berlin, Germany.; Berlin Institute of Health (BIH), Berlin, Germany.
Haeusler KG; Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany. Haeusler_.
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Źródło :
Journal of neurology [J Neurol] 2022 Jan; Vol. 269 (1), pp. 470-480. Date of Electronic Publication: 2021 Oct 31.
Typ publikacji :
Journal Article; Multicenter Study
Język :
English
Imprint Name(s) :
Original Publication: Berlin ; New York, Springer-Verlag
MeSH Terms :
Atrial Fibrillation*/complications
Atrial Fibrillation*/drug therapy
Brain Ischemia*/complications
Brain Ischemia*/drug therapy
Stroke*/complications
Stroke*/drug therapy
Administration, Oral ; Aged, 80 and over ; Anticoagulants/therapeutic use ; Berlin ; Humans ; Off-Label Use ; Prospective Studies ; Registries
References :
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Contributed Indexing :
Keywords: Atrial fibrillation; Ischemic stroke; NOAC; Under-dosing
Molecular Sequence :
ClinicalTrials.gov NCT02306824
Substance Nomenclature :
0 (Anticoagulants)
Entry Date(s) :
Date Created: 20211031 Date Completed: 20220110 Latest Revision: 20220218
Update Code :
20220218
PubMed Central ID :
PMC8739306
DOI :
10.1007/s00415-021-10866-2
PMID :
34718884
Czasopismo naukowe
Aims: We aimed to analyze prevalence and predictors of NOAC off-label under-dosing in AF patients before and after the index stroke.
Methods: The post hoc analysis included 1080 patients of the investigator-initiated, multicenter prospective Berlin Atrial Fibrillation Registry, designed to analyze medical stroke prevention in AF patients after acute ischemic stroke.
Results: At stroke onset, an off-label daily dose was prescribed in 61 (25.5%) of 239 NOAC patients with known AF and CHA 2 DS 2 -VASc score ≥ 1, of which 52 (21.8%) patients were under-dosed. Under-dosing was associated with age ≥ 80 years in patients on rivaroxaban [OR 2.90, 95% CI 1.05-7.9, P = 0.04; n = 29] or apixaban [OR 3.24, 95% CI 1.04-10.1, P = 0.04; n = 22]. At hospital discharge after the index stroke, NOAC off-label dose on admission was continued in 30 (49.2%) of 61 patients. Overall, 79 (13.7%) of 708 patients prescribed a NOAC at hospital discharge received an off-label dose, of whom 75 (10.6%) patients were under-dosed. Rivaroxaban under-dosing at discharge was associated with age ≥ 80 years [OR 3.49, 95% CI 1.24-9.84, P = 0.02; n = 19]; apixaban under-dosing with body weight ≤ 60 kg [OR 0.06, 95% CI 0.01-0.47, P < 0.01; n = 56], CHA 2 DS 2 -VASc score [OR per point 1.47, 95% CI 1.08-2.00, P = 0.01], and HAS-BLED score [OR per point 1.91, 95% CI 1.28-2.84, P < 0.01].
Conclusion: At stroke onset, off-label dosing was present in one out of four, and under-dosing in one out of five NOAC patients. Under-dosing of rivaroxaban or apixaban was related to old age. In-hospital treatment after stroke reduced off-label NOAC dosing, but one out of ten NOAC patients was under-dosed at discharge.
Clinical Trial Registration: NCT02306824.
(© 2021. The Author(s).)
Erratum in: J Neurol. 2021 Nov 27;:. (PMID: 34837502)

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