Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases

ObjectiveVortioxetine is a multimodal antidepressant approved for the treatment of major depressive episodes. As part of the overall European risk-management plan, we aimed to fill data gaps on relevant missing information such as the extent of vortioxetine use in special populations and assessment...

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Autores: Andersohn F, Christensen MC, Creuwels L, Aznar-Lou I, Rubio-Valera M, Penning-van Beest F, Houben E, Hernandez P, Hakkarainen KM, Reines EH
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Fundació Sant Joan de Déu
Repositorio:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:oai:fsjd.fundanetsuite.com:p29192
Acceso en línea:https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=29192
Access Level:acceso abierto
Palabra clave:Major depressive disorder
vortioxetine
safety
adverse events
elderly
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spelling Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databasesAndersohn FChristensen MCCreuwels LAznar-Lou IRubio-Valera MPenning-van Beest FHouben EHernandez PHakkarainen KMReines EHMajor depressive disordervortioxetinesafetyadverse eventselderlyObjectiveVortioxetine is a multimodal antidepressant approved for the treatment of major depressive episodes. As part of the overall European risk-management plan, we aimed to fill data gaps on relevant missing information such as the extent of vortioxetine use in special populations and assessment of selected potential risks.MethodsThis non-interventional post-authorization safety study used longitudinal administrative claims/medical records data from 10,358 patients newly prescribed vortioxetine in Finland, Spain, and the Netherlands (EU-PAS register: EUPAS19199).ResultsElderly patients (>= 75 years) accounted for 3-14% of the assessed populations, while off-label pediatric prescribing was low (0.1-0.5%). Patients with a comorbid diagnosis of mania/hypomania accounted for 0.4-10% of the population, while patients with comorbid neurological conditions accounted for <= 3% of patients. The median prescribed daily vortioxetine dose was 10 mg and mean exposure was 72-238 days. The proportions of patients who had one of the events of interest (suicidal events, epilepsy, convulsions/seizures, severe renal or hepatic events) recorded during vortioxetine exposure were all <= 1%.ConclusionIn this European healthcare database study, the extent and characteristics of vortioxetine use were in line with clinical trial experience and the current label. Analyses of events, including those of special interest, did not raise any new safety concerns.TAYLOR & FRANCIS LTD2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=29192CURRENT MEDICAL RESEARCH AND OPINIONISSN: 03007995ISSNe: 14734877reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déuinstname:Fundació Sant Joan de DéuInglésinfo:eu-repo/semantics/openAccessoai:fsjd.fundanetsuite.com:p291922026-05-27T12:37:41Z
dc.title.none.fl_str_mv Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
title Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
spellingShingle Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
Andersohn F
Major depressive disorder
vortioxetine
safety
adverse events
elderly
title_short Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
title_full Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
title_fullStr Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
title_full_unstemmed Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
title_sort Vortioxetine in the routine management of major depressive disorder: an analysis of European automated healthcare databases
dc.creator.none.fl_str_mv Andersohn F
Christensen MC
Creuwels L
Aznar-Lou I
Rubio-Valera M
Penning-van Beest F
Houben E
Hernandez P
Hakkarainen KM
Reines EH
author Andersohn F
author_facet Andersohn F
Christensen MC
Creuwels L
Aznar-Lou I
Rubio-Valera M
Penning-van Beest F
Houben E
Hernandez P
Hakkarainen KM
Reines EH
author_role author
author2 Christensen MC
Creuwels L
Aznar-Lou I
Rubio-Valera M
Penning-van Beest F
Houben E
Hernandez P
Hakkarainen KM
Reines EH
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Major depressive disorder
vortioxetine
safety
adverse events
elderly
topic Major depressive disorder
vortioxetine
safety
adverse events
elderly
description ObjectiveVortioxetine is a multimodal antidepressant approved for the treatment of major depressive episodes. As part of the overall European risk-management plan, we aimed to fill data gaps on relevant missing information such as the extent of vortioxetine use in special populations and assessment of selected potential risks.MethodsThis non-interventional post-authorization safety study used longitudinal administrative claims/medical records data from 10,358 patients newly prescribed vortioxetine in Finland, Spain, and the Netherlands (EU-PAS register: EUPAS19199).ResultsElderly patients (>= 75 years) accounted for 3-14% of the assessed populations, while off-label pediatric prescribing was low (0.1-0.5%). Patients with a comorbid diagnosis of mania/hypomania accounted for 0.4-10% of the population, while patients with comorbid neurological conditions accounted for <= 3% of patients. The median prescribed daily vortioxetine dose was 10 mg and mean exposure was 72-238 days. The proportions of patients who had one of the events of interest (suicidal events, epilepsy, convulsions/seizures, severe renal or hepatic events) recorded during vortioxetine exposure were all <= 1%.ConclusionIn this European healthcare database study, the extent and characteristics of vortioxetine use were in line with clinical trial experience and the current label. Analyses of events, including those of special interest, did not raise any new safety concerns.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=29192
url https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=29192
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv TAYLOR & FRANCIS LTD
publisher.none.fl_str_mv TAYLOR & FRANCIS LTD
dc.source.none.fl_str_mv CURRENT MEDICAL RESEARCH AND OPINION
ISSN: 03007995
ISSNe: 14734877
reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname:Fundació Sant Joan de Déu
instname_str Fundació Sant Joan de Déu
reponame_str r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
collection r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
repository.name.fl_str_mv
repository.mail.fl_str_mv
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