SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population

Introduction. Parkinson's Disease (PD) is a progressive age-related neurodegenerative condition requiring new therapeutic alternatives. Safinamide, a novel levodopa add-on therapy, positively affects disease fluctuations by modulating both dopaminergic and glutamatergic systems. To further inve...

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Autores: Kulisevsky, J, Esquivel, A, Freire-Alvarez, E, Gómez-Esteban, JC, Legarda-Ramírez, I, Mata-Alvarez-Satullano, M
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2023
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositório:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p16218
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/16218
Access Level:Acceso aberto
Palavra-chave:Dyskinesias
Levodopa
Motor complications
Non-motor complications
Parkinson's disease
Safinamide
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spelling SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study populationKulisevsky, JEsquivel, AFreire-Alvarez, EGómez-Esteban, JCLegarda-Ramírez, IMata-Alvarez-Satullano, MDyskinesiasLevodopaMotor complicationsNon-motor complicationsParkinson's diseaseSafinamideIntroduction. Parkinson's Disease (PD) is a progressive age-related neurodegenerative condition requiring new therapeutic alternatives. Safinamide, a novel levodopa add-on therapy, positively affects disease fluctuations by modulating both dopaminergic and glutamatergic systems. To further investigate the use of safinamide in European routine clinical practice, the present post-hoc analysis aimed to understand safinamide's safety profile within the Spanish study population. Patients and methods. Five hundred eleven Spanish patients with PD were evaluated at baseline, four (+/- 1), eight (+/- 1), and 12 (+/- 1) months after initiating safinamide treatment. Unified Parkinson's Disease Rating Scale (UPDRS) total score and UPDRS part III score during on time were used to measure the overall severity of PD and motor complications, respectively, while the severity of adverse events was evaluated following the investigators' criteria. Results. Safinamide showed a favourable safety profile within the Spanish study population, although prescription to patients with psychiatric conditions and off-label use were more frequent than in the European study population. In Spain, clinically meaningful improvements were observed in UPDRS scores when safinamide was used as the only add-on therapy to levodopa (57.4% and 53.7% of patients) and when switching from rasagiline (55.1% of patients). Motor complications were reduced from 83.2% to 63.3% after the study period. Increased safety concerns were undetected in any patient subgroup, although patients with cognitive impairment showed a slightly higher frequency of adverse events. Conclusions. This subanalysis further supports safinamide use as a safe and efficacious option for the management of motor fluctuations in different subgroups of levodopa-treated patients. However, safinamide should be used with caution in patients with cognitive impairment.IMR PRESS2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/16218REVISTA DE NEUROLOGIAISSN: 02100010ISSNe: 15766578reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Españolinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p162182026-06-11T12:45:17Z
dc.title.none.fl_str_mv SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
title SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
spellingShingle SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
Kulisevsky, J
Dyskinesias
Levodopa
Motor complications
Non-motor complications
Parkinson's disease
Safinamide
title_short SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
title_full SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
title_fullStr SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
title_full_unstemmed SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
title_sort SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: <i>post-hoc</i> analysis of the Spanish study population
dc.creator.none.fl_str_mv Kulisevsky, J
Esquivel, A
Freire-Alvarez, E
Gómez-Esteban, JC
Legarda-Ramírez, I
Mata-Alvarez-Satullano, M
author Kulisevsky, J
author_facet Kulisevsky, J
Esquivel, A
Freire-Alvarez, E
Gómez-Esteban, JC
Legarda-Ramírez, I
Mata-Alvarez-Satullano, M
author_role author
author2 Esquivel, A
Freire-Alvarez, E
Gómez-Esteban, JC
Legarda-Ramírez, I
Mata-Alvarez-Satullano, M
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv Dyskinesias
Levodopa
Motor complications
Non-motor complications
Parkinson's disease
Safinamide
topic Dyskinesias
Levodopa
Motor complications
Non-motor complications
Parkinson's disease
Safinamide
description Introduction. Parkinson's Disease (PD) is a progressive age-related neurodegenerative condition requiring new therapeutic alternatives. Safinamide, a novel levodopa add-on therapy, positively affects disease fluctuations by modulating both dopaminergic and glutamatergic systems. To further investigate the use of safinamide in European routine clinical practice, the present post-hoc analysis aimed to understand safinamide's safety profile within the Spanish study population. Patients and methods. Five hundred eleven Spanish patients with PD were evaluated at baseline, four (+/- 1), eight (+/- 1), and 12 (+/- 1) months after initiating safinamide treatment. Unified Parkinson's Disease Rating Scale (UPDRS) total score and UPDRS part III score during on time were used to measure the overall severity of PD and motor complications, respectively, while the severity of adverse events was evaluated following the investigators' criteria. Results. Safinamide showed a favourable safety profile within the Spanish study population, although prescription to patients with psychiatric conditions and off-label use were more frequent than in the European study population. In Spain, clinically meaningful improvements were observed in UPDRS scores when safinamide was used as the only add-on therapy to levodopa (57.4% and 53.7% of patients) and when switching from rasagiline (55.1% of patients). Motor complications were reduced from 83.2% to 63.3% after the study period. Increased safety concerns were undetected in any patient subgroup, although patients with cognitive impairment showed a slightly higher frequency of adverse events. Conclusions. This subanalysis further supports safinamide use as a safe and efficacious option for the management of motor fluctuations in different subgroups of levodopa-treated patients. However, safinamide should be used with caution in patients with cognitive impairment.
publishDate 2023
dc.date.none.fl_str_mv 2023
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://fisabio.portalinvestigacion.com/publicaciones/16218
url https://fisabio.portalinvestigacion.com/publicaciones/16218
dc.language.none.fl_str_mv Español
language_invalid_str_mv Español
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv IMR PRESS
publisher.none.fl_str_mv IMR PRESS
dc.source.none.fl_str_mv REVISTA DE NEUROLOGIA
ISSN: 02100010
ISSNe: 15766578
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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