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A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice

Safinamide is an approved drug for the treatment of motor fluctuations in Parkinson’s disease (PD). Scarce data are available on its use in clinical practice. A group of Spanish movement disorders specialists was convened to review the use of safinamide across different clinical scenarios that may g...

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Autores principales: Pagonabarraga, Javier, Arbelo, José Matías, Grandas, Francisco, Luquin, Maria-Rosario, Martínez Martín, Pablo, Rodríguez-Oroz, Mari Cruz, Valldeoriola, Francesc, Kulisevsky, Jaime
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7139287/
https://www.ncbi.nlm.nih.gov/pubmed/32197462
http://dx.doi.org/10.3390/brainsci10030176
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author Pagonabarraga, Javier
Arbelo, José Matías
Grandas, Francisco
Luquin, Maria-Rosario
Martínez Martín, Pablo
Rodríguez-Oroz, Mari Cruz
Valldeoriola, Francesc
Kulisevsky, Jaime
author_facet Pagonabarraga, Javier
Arbelo, José Matías
Grandas, Francisco
Luquin, Maria-Rosario
Martínez Martín, Pablo
Rodríguez-Oroz, Mari Cruz
Valldeoriola, Francesc
Kulisevsky, Jaime
author_sort Pagonabarraga, Javier
collection PubMed
description Safinamide is an approved drug for the treatment of motor fluctuations in Parkinson’s disease (PD). Scarce data are available on its use in clinical practice. A group of Spanish movement disorders specialists was convened to review the use of safinamide across different clinical scenarios that may guide neurologists in clinical practice. Eight specialists with recognized expertise in PD management elaborated the statements based on available evidence in the literature and on their clinical experience. The RAND/UCLA method was carried, with final conclusions accepted after a 2-round modified Delphi process. Higher level of agreement between panellists was reached for the following statements. Safinamide significantly improves mean daily OFF time without troublesome dyskinesias. Adjunctive treatment with safinamide is associated with motor improvements in patients with mid-to-late PD. The efficacy of safinamide on motor fluctuations is maintained at long-term, with no increase over time in dyskinesias severity. The clinical benefits of safinamide on pain and depression remain unclear. Safinamide presents a similar incidence of adverse events compared with placebo. The efficacy and safety of safinamide shown in the pivotal clinical trials are reproduced in clinical practice, with improvement of parkinsonian symptoms, decrease of daily OFF time, control of dyskinesias at the long term, and good tolerability and safety.
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spelling pubmed-71392872020-04-10 A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice Pagonabarraga, Javier Arbelo, José Matías Grandas, Francisco Luquin, Maria-Rosario Martínez Martín, Pablo Rodríguez-Oroz, Mari Cruz Valldeoriola, Francesc Kulisevsky, Jaime Brain Sci Review Safinamide is an approved drug for the treatment of motor fluctuations in Parkinson’s disease (PD). Scarce data are available on its use in clinical practice. A group of Spanish movement disorders specialists was convened to review the use of safinamide across different clinical scenarios that may guide neurologists in clinical practice. Eight specialists with recognized expertise in PD management elaborated the statements based on available evidence in the literature and on their clinical experience. The RAND/UCLA method was carried, with final conclusions accepted after a 2-round modified Delphi process. Higher level of agreement between panellists was reached for the following statements. Safinamide significantly improves mean daily OFF time without troublesome dyskinesias. Adjunctive treatment with safinamide is associated with motor improvements in patients with mid-to-late PD. The efficacy of safinamide on motor fluctuations is maintained at long-term, with no increase over time in dyskinesias severity. The clinical benefits of safinamide on pain and depression remain unclear. Safinamide presents a similar incidence of adverse events compared with placebo. The efficacy and safety of safinamide shown in the pivotal clinical trials are reproduced in clinical practice, with improvement of parkinsonian symptoms, decrease of daily OFF time, control of dyskinesias at the long term, and good tolerability and safety. MDPI 2020-03-18 /pmc/articles/PMC7139287/ /pubmed/32197462 http://dx.doi.org/10.3390/brainsci10030176 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Pagonabarraga, Javier
Arbelo, José Matías
Grandas, Francisco
Luquin, Maria-Rosario
Martínez Martín, Pablo
Rodríguez-Oroz, Mari Cruz
Valldeoriola, Francesc
Kulisevsky, Jaime
A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice
title A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice
title_full A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice
title_fullStr A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice
title_full_unstemmed A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice
title_short A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice
title_sort spanish consensus on the use of safinamide for parkinson’s disease in clinical practice
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7139287/
https://www.ncbi.nlm.nih.gov/pubmed/32197462
http://dx.doi.org/10.3390/brainsci10030176
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