The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease

IntroductionEthnicity 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 safin...

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Autores: Cattaneo, C, Kulisevsky, J
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p17443
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17443
Access Level:acceso abierto
Palabra clave:Parkinson's disease
Safinamide
Ethnicity
Motor fluctuations
Glutamate
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spelling The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's DiseaseCattaneo, CKulisevsky, JParkinson's diseaseSafinamideEthnicityMotor fluctuationsGlutamateIntroductionEthnicity 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.MethodsSETTLE (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.ResultsSignificant 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.ConclusionsSafinamide 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.Trial Registration NumberSETTLE (NCT00627640) and XINDI (NCT03881371).SPRINGER2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17443ADVANCES IN THERAPYISSN: 0741238XISSNe: 18658652reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p174432026-06-14T12:41:47Z
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, C
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, C
Kulisevsky, J
author Cattaneo, C
author_facet Cattaneo, C
Kulisevsky, J
author_role author
author2 Kulisevsky, J
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 IntroductionEthnicity 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.MethodsSETTLE (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.ResultsSignificant 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.ConclusionsSafinamide 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.Trial Registration NumberSETTLE (NCT00627640) and XINDI (NCT03881371).
publishDate 2023
dc.date.none.fl_str_mv 2023
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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 SPRINGER
publisher.none.fl_str_mv SPRINGER
dc.source.none.fl_str_mv ADVANCES IN THERAPY
ISSN: 0741238X
ISSNe: 18658652
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
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