A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson’s disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the Eu...

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Autores: Abbruzzese, Giovanni, Kulisevsky Bojarsky, Jaume, Bergmansº, Bruno, Gómez Esteban, Juan Carlos, Kägi, Georg, Stefani, Alessandro, Warnecke, Tobias, Jost, Wolfgang H., Cubo Delgado, Esther, SYNAPSES Study Investigators Group
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Universidad de Burgos (UBU)
Repositorio:Repositorio Institucional de la Universidad de Burgos (RIUBU)
OAI Identifier:oai:riubu.ubu.es:10259/8816
Acceso en línea:http://hdl.handle.net/10259/8816
Access Level:acceso abierto
Palabra clave:Parkinson’s disease
Safinamide
MAO-B inhibitor
Real-life evaluation
Sistema nervioso-Enfermedades
Medicina
Neurología
Nervous system-Diseases
Medicine
Neurology
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spelling A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES TrialAbbruzzese, GiovanniKulisevsky Bojarsky, JaumeBergmansº, BrunoGómez Esteban, Juan CarlosKägi, GeorgStefani, AlessandroWarnecke, TobiasJost, Wolfgang H.Cubo Delgado, EstherSYNAPSES Study Investigators GroupParkinson’s diseaseSafinamideMAO-B inhibitorReal-life evaluationSistema nervioso-EnfermedadesMedicinaNeurologíaNervous system-DiseasesMedicineNeurologyBackground: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson’s disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients’ information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in ≥40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.IOS Press202420242021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://hdl.handle.net/10259/8816reponame:Repositorio Institucional de la Universidad de Burgos (RIUBU)instname:Universidad de Burgos (UBU)InglésJournal of Parkinson's Disease. 2021, V. 11, n. 1, p. 187-198https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202224Atribución 4.0 Internacionalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:riubu.ubu.es:10259/88162026-05-28T07:56:11Z
dc.title.none.fl_str_mv A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
title A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
spellingShingle A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
Abbruzzese, Giovanni
Parkinson’s disease
Safinamide
MAO-B inhibitor
Real-life evaluation
Sistema nervioso-Enfermedades
Medicina
Neurología
Nervous system-Diseases
Medicine
Neurology
title_short A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
title_full A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
title_fullStr A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
title_full_unstemmed A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
title_sort A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
dc.creator.none.fl_str_mv Abbruzzese, Giovanni
Kulisevsky Bojarsky, Jaume
Bergmansº, Bruno
Gómez Esteban, Juan Carlos
Kägi, Georg
Stefani, Alessandro
Warnecke, Tobias
Jost, Wolfgang H.
Cubo Delgado, Esther
SYNAPSES Study Investigators Group
author Abbruzzese, Giovanni
author_facet Abbruzzese, Giovanni
Kulisevsky Bojarsky, Jaume
Bergmansº, Bruno
Gómez Esteban, Juan Carlos
Kägi, Georg
Stefani, Alessandro
Warnecke, Tobias
Jost, Wolfgang H.
Cubo Delgado, Esther
SYNAPSES Study Investigators Group
author_role author
author2 Kulisevsky Bojarsky, Jaume
Bergmansº, Bruno
Gómez Esteban, Juan Carlos
Kägi, Georg
Stefani, Alessandro
Warnecke, Tobias
Jost, Wolfgang H.
Cubo Delgado, Esther
SYNAPSES Study Investigators Group
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Parkinson’s disease
Safinamide
MAO-B inhibitor
Real-life evaluation
Sistema nervioso-Enfermedades
Medicina
Neurología
Nervous system-Diseases
Medicine
Neurology
topic Parkinson’s disease
Safinamide
MAO-B inhibitor
Real-life evaluation
Sistema nervioso-Enfermedades
Medicina
Neurología
Nervous system-Diseases
Medicine
Neurology
description Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson’s disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients’ information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in ≥40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.
publishDate 2021
dc.date.none.fl_str_mv 2021
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/10259/8816
url http://hdl.handle.net/10259/8816
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Journal of Parkinson's Disease. 2021, V. 11, n. 1, p. 187-198
https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202224
dc.rights.none.fl_str_mv Atribución 4.0 Internacional
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Atribución 4.0 Internacional
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv IOS Press
publisher.none.fl_str_mv IOS Press
dc.source.none.fl_str_mv reponame:Repositorio Institucional de la Universidad de Burgos (RIUBU)
instname:Universidad de Burgos (UBU)
instname_str Universidad de Burgos (UBU)
reponame_str Repositorio Institucional de la Universidad de Burgos (RIUBU)
collection Repositorio Institucional de la Universidad de Burgos (RIUBU)
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.300719

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