The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease

Introduction. Ethnicity differences are an important determinant in the clinical manifestation of Parkinson’s disease (PD), but they are not yet widely recognized, particularly regarding the response to dopaminergic medications. The aim of this paper is to analyze the efficacy and safety of safinami...

ver descrição completa

Detalhes bibliográficos
Autores: Cattaneo, Carlo, Kulisevsky, Jaime
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2024
País:España
Recursos:Universitat Oberta de Catalunya (UOC)
Repositório:O2, repositorio institucional de la UOC
OAI Identifier:oai:openaccess.uoc.edu:10609/151426
Acesso em linha:http://hdl.handle.net/10609/151426
https://doi.org/10.1007/s12325-023-02736-2
Access Level:Acceso aberto
Palavra-chave:Parkinson’s disease
safinamide
ethnicity
motor fluctuations
glutamate
id ES_f5fb10d1b458e1840e02e890c7bde36e
oai_identifier_str oai:openaccess.uoc.edu:10609/151426
network_acronym_str ES
network_name_str España
repository_id_str
spelling The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s diseaseCattaneo, CarloKulisevsky, JaimeParkinson’s diseasesafinamideethnicitymotor fluctuationsglutamateIntroduction. Ethnicity differences are an important determinant in the clinical manifestation of Parkinson’s disease (PD), but they are not yet widely recognized, particularly regarding the response to dopaminergic medications. The aim of this paper is to analyze the efficacy and safety of safinamide in Chinese patients with PD in the pivotal studies SETTLE and XINDI compared to the non-Chinese population of the SETTLE trial. Methods. SETTLE (NCT00627640) and XINDI (NCT03881371) were phase III, randomized, double-blind, placebo-controlled, multicenter trials. Patients received safinamide or placebo as add-on to levodopa. The primary efficacy endpoint was the change in the mean total daily OFF time. Secondary efficacy endpoints included total daily ON time, ON time with no/non-troublesome dyskinesia, Unified Parkinson’s Disease Rating Scale, and Parkinson’s Disease Questionnaire-39 items. Safety was evaluated through the frequency of adverse events. Data from 440 non-Chinese and 109 Chinese patients in the SETTLE study, and 305 Chinese patients in the XINDI trial were considered for this post hoc analysis. Results. Significant positive results were seen in favor of safinamide in all populations for the primary and secondary endpoints, with no differences in terms of magnitude. No “treatment by ethnicity” interaction was detected for any parameters, confirming the homogeneity of treatment effects between different populations. The safety and tolerability of safinamide in Chinese patients were similar to those in the other ethnic groups, without unexpected adverse reactions. Conclusions. Safinamide was shown to improve PD symptoms and quality of life in different ethnic populations, without any treatment by race interaction. Further studies are warranted to investigate potential differences in a real-life situation.Springer Nature202420242024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10609/151426https://doi.org/10.1007/s12325-023-02736-2reponame:O2, repositorio institucional de la UOCinstname:Universitat Oberta de Catalunya (UOC)InglésAdvances in Therapy, 2024, 41(2)https://link.springer.com/article/10.1007/s12325-023-02736-2/metricshttps://link.springer.com/article/10.1007/s12325-023-02736-2CC BY-NChttp://creativecommons.org/licenses/by-nc/3.0/es/info:eu-repo/semantics/openAccessoai:openaccess.uoc.edu:10609/1514262026-05-28T12:42:01Z
dc.title.none.fl_str_mv The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
title The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
spellingShingle The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
Cattaneo, Carlo
Parkinson’s disease
safinamide
ethnicity
motor fluctuations
glutamate
title_short The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
title_full The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
title_fullStr The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
title_full_unstemmed The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
title_sort The effects of safinamide in Chinese and non-Chinese patients with Parkinson’s disease
dc.creator.none.fl_str_mv Cattaneo, Carlo
Kulisevsky, Jaime
author Cattaneo, Carlo
author_facet Cattaneo, Carlo
Kulisevsky, Jaime
author_role author
author2 Kulisevsky, Jaime
author2_role author
dc.subject.none.fl_str_mv Parkinson’s disease
safinamide
ethnicity
motor fluctuations
glutamate
topic Parkinson’s disease
safinamide
ethnicity
motor fluctuations
glutamate
description Introduction. Ethnicity differences are an important determinant in the clinical manifestation of Parkinson’s disease (PD), but they are not yet widely recognized, particularly regarding the response to dopaminergic medications. The aim of this paper is to analyze the efficacy and safety of safinamide in Chinese patients with PD in the pivotal studies SETTLE and XINDI compared to the non-Chinese population of the SETTLE trial. Methods. SETTLE (NCT00627640) and XINDI (NCT03881371) were phase III, randomized, double-blind, placebo-controlled, multicenter trials. Patients received safinamide or placebo as add-on to levodopa. The primary efficacy endpoint was the change in the mean total daily OFF time. Secondary efficacy endpoints included total daily ON time, ON time with no/non-troublesome dyskinesia, Unified Parkinson’s Disease Rating Scale, and Parkinson’s Disease Questionnaire-39 items. Safety was evaluated through the frequency of adverse events. Data from 440 non-Chinese and 109 Chinese patients in the SETTLE study, and 305 Chinese patients in the XINDI trial were considered for this post hoc analysis. Results. Significant positive results were seen in favor of safinamide in all populations for the primary and secondary endpoints, with no differences in terms of magnitude. No “treatment by ethnicity” interaction was detected for any parameters, confirming the homogeneity of treatment effects between different populations. The safety and tolerability of safinamide in Chinese patients were similar to those in the other ethnic groups, without unexpected adverse reactions. Conclusions. Safinamide was shown to improve PD symptoms and quality of life in different ethnic populations, without any treatment by race interaction. Further studies are warranted to investigate potential differences in a real-life situation.
publishDate 2024
dc.date.none.fl_str_mv 2024
2024
2024
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 http://hdl.handle.net/10609/151426
https://doi.org/10.1007/s12325-023-02736-2
url http://hdl.handle.net/10609/151426
https://doi.org/10.1007/s12325-023-02736-2
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Advances in Therapy, 2024, 41(2)
https://link.springer.com/article/10.1007/s12325-023-02736-2/metrics
https://link.springer.com/article/10.1007/s12325-023-02736-2
dc.rights.none.fl_str_mv CC BY-NC
http://creativecommons.org/licenses/by-nc/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv CC BY-NC
http://creativecommons.org/licenses/by-nc/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Springer Nature
publisher.none.fl_str_mv Springer Nature
dc.source.none.fl_str_mv reponame:O2, repositorio institucional de la UOC
instname:Universitat Oberta de Catalunya (UOC)
instname_str Universitat Oberta de Catalunya (UOC)
reponame_str O2, repositorio institucional de la UOC
collection O2, repositorio institucional de la UOC
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869424666803699712
score 15,812455

Registros relacionados