Cargando…

Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

AIM: To investigate the effects of off‐label non‐vitamin K oral anticoagulant (NOAC) dose reduction compared with on‐label standard dosing in atrial fibrillation (AF) patients in routine care. METHODS: Population‐based cohort study using data from the United Kingdom Clinical Practice Research Datali...

Descripción completa

Detalles Bibliográficos
Autores principales: van den Dries, Carline J., Pajouheshnia, Romin, van den Ham, Hendrika A., Souverein, Patrick, Moons, Karel G. M., Hoes, Arno W., Geersing, Geert‐Jan, van Doorn, Sander
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10091743/
https://www.ncbi.nlm.nih.gov/pubmed/36102068
http://dx.doi.org/10.1111/bcp.15534
_version_ 1785023190485958656
author van den Dries, Carline J.
Pajouheshnia, Romin
van den Ham, Hendrika A.
Souverein, Patrick
Moons, Karel G. M.
Hoes, Arno W.
Geersing, Geert‐Jan
van Doorn, Sander
author_facet van den Dries, Carline J.
Pajouheshnia, Romin
van den Ham, Hendrika A.
Souverein, Patrick
Moons, Karel G. M.
Hoes, Arno W.
Geersing, Geert‐Jan
van Doorn, Sander
author_sort van den Dries, Carline J.
collection PubMed
description AIM: To investigate the effects of off‐label non‐vitamin K oral anticoagulant (NOAC) dose reduction compared with on‐label standard dosing in atrial fibrillation (AF) patients in routine care. METHODS: Population‐based cohort study using data from the United Kingdom Clinical Practice Research Datalink, comparing adults with non‐valvular AF receiving an off‐label reduced NOAC dose to patients receiving an on‐label standard dose. Outcomes were ischaemic stroke, major/non‐major bleeding and mortality. Inverse probability of treatment weighting and inverse probability of censoring weighting on the propensity score were applied to adjust for confounding and informative censoring. RESULTS: Off‐label dose reduction occurred in 2466 patients (8.0%), compared with 18 108 (58.5%) on‐label standard‐dose users. Median age was 80 years (interquartile range [IQR] 73.0‐86.0) versus 72 years (IQR 66‐78), respectively. Incidence rates were higher in the off‐label dose reduction group compared to the on‐label standard dose group, for ischaemic stroke (0.94 vs 0.70 per 100 person years), major bleeding (1.48 vs 0.83), non‐major bleeding (6.78 vs 6.16) and mortality (10.12 vs 3.72). Adjusted analyses resulted in a hazard ratio of 0.95 (95% confidence interval [CI] 0.57‐1.60) for ischaemic stroke, 0.88 (95% CI 0.57‐1.35) for major bleeding, 0.81 (95% CI 0.67‐0.98) for non‐major bleeding and 1.34 (95% CI 1.12‐1.61) for mortality. CONCLUSION: In this large population‐based study, the hazards for ischaemic stroke and major bleeding were low, and similar in AF patients receiving an off‐label reduced NOAC dose compared with on‐label standard dose users, while non‐major bleeding risk appeared to be lower and mortality risk higher. Caution towards prescribing an off‐label reduced NOAC dose is therefore required.
format Online
Article
Text
id pubmed-10091743
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-100917432023-04-13 Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation van den Dries, Carline J. Pajouheshnia, Romin van den Ham, Hendrika A. Souverein, Patrick Moons, Karel G. M. Hoes, Arno W. Geersing, Geert‐Jan van Doorn, Sander Br J Clin Pharmacol Original Articles AIM: To investigate the effects of off‐label non‐vitamin K oral anticoagulant (NOAC) dose reduction compared with on‐label standard dosing in atrial fibrillation (AF) patients in routine care. METHODS: Population‐based cohort study using data from the United Kingdom Clinical Practice Research Datalink, comparing adults with non‐valvular AF receiving an off‐label reduced NOAC dose to patients receiving an on‐label standard dose. Outcomes were ischaemic stroke, major/non‐major bleeding and mortality. Inverse probability of treatment weighting and inverse probability of censoring weighting on the propensity score were applied to adjust for confounding and informative censoring. RESULTS: Off‐label dose reduction occurred in 2466 patients (8.0%), compared with 18 108 (58.5%) on‐label standard‐dose users. Median age was 80 years (interquartile range [IQR] 73.0‐86.0) versus 72 years (IQR 66‐78), respectively. Incidence rates were higher in the off‐label dose reduction group compared to the on‐label standard dose group, for ischaemic stroke (0.94 vs 0.70 per 100 person years), major bleeding (1.48 vs 0.83), non‐major bleeding (6.78 vs 6.16) and mortality (10.12 vs 3.72). Adjusted analyses resulted in a hazard ratio of 0.95 (95% confidence interval [CI] 0.57‐1.60) for ischaemic stroke, 0.88 (95% CI 0.57‐1.35) for major bleeding, 0.81 (95% CI 0.67‐0.98) for non‐major bleeding and 1.34 (95% CI 1.12‐1.61) for mortality. CONCLUSION: In this large population‐based study, the hazards for ischaemic stroke and major bleeding were low, and similar in AF patients receiving an off‐label reduced NOAC dose compared with on‐label standard dose users, while non‐major bleeding risk appeared to be lower and mortality risk higher. Caution towards prescribing an off‐label reduced NOAC dose is therefore required. John Wiley and Sons Inc. 2022-10-03 2023-02 /pmc/articles/PMC10091743/ /pubmed/36102068 http://dx.doi.org/10.1111/bcp.15534 Text en © 2022 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
van den Dries, Carline J.
Pajouheshnia, Romin
van den Ham, Hendrika A.
Souverein, Patrick
Moons, Karel G. M.
Hoes, Arno W.
Geersing, Geert‐Jan
van Doorn, Sander
Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
title Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
title_full Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
title_fullStr Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
title_full_unstemmed Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
title_short Safety of off‐label dose reduction of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation
title_sort safety of off‐label dose reduction of non‐vitamin k antagonist oral anticoagulants in patients with atrial fibrillation
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10091743/
https://www.ncbi.nlm.nih.gov/pubmed/36102068
http://dx.doi.org/10.1111/bcp.15534
work_keys_str_mv AT vandendriescarlinej safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation
AT pajouheshniaromin safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation
AT vandenhamhendrikaa safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation
AT souvereinpatrick safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation
AT moonskarelgm safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation
AT hoesarnow safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation
AT geersinggeertjan safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation
AT vandoornsander safetyofofflabeldosereductionofnonvitaminkantagonistoralanticoagulantsinpatientswithatrialfibrillation