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...
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doaj-0a99cea1e0de4a0d9eeb8bd90dfc53282020-11-25T02:32:09ZengMDPI AGBrain Sciences2076-34252020-03-0110317610.3390/brainsci10030176brainsci10030176A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical PracticeJavier Pagonabarraga0José Matías Arbelo1Francisco Grandas2Maria-Rosario Luquin3Pablo Martínez Martín4Mari Cruz Rodríguez-Oroz5Francesc Valldeoriola6Jaime Kulisevsky7Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, SpainMovement Disorders Unit, Neurology Department, Hospital Universitario San Roque, 35001 Las Palmas, SpainMovement Disorders Unit-CSUR, Neurology Department, Hospital General Universitario Gregorio Marañón, 28007 Madrid, SpainMovement Disorders Unit, Clínica Universidad de Navarra (CUN), 31008 Pamplona, SpainInstituto de Salud Carlos III, 28029 Madrid, SpainNeurology and Neuroscience Unit, Clínica Universidad de Navarra (CUN), 31008Pamplona, SpainNeurosciences Institut, Hospital Clinic de Barcelona, 08036 Barcelona, SpainMovement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, SpainSafinamide 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.https://www.mdpi.com/2076-3425/10/3/176safinamideefficacysafetyfluctuationsdyskinesiarand/ucla appropriateness method |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Javier Pagonabarraga José Matías Arbelo Francisco Grandas Maria-Rosario Luquin Pablo Martínez Martín Mari Cruz Rodríguez-Oroz Francesc Valldeoriola Jaime Kulisevsky |
spellingShingle |
Javier Pagonabarraga José Matías Arbelo Francisco Grandas Maria-Rosario Luquin Pablo Martínez Martín Mari Cruz Rodríguez-Oroz Francesc Valldeoriola Jaime Kulisevsky A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice Brain Sciences safinamide efficacy safety fluctuations dyskinesia rand/ucla appropriateness method |
author_facet |
Javier Pagonabarraga José Matías Arbelo Francisco Grandas Maria-Rosario Luquin Pablo Martínez Martín Mari Cruz Rodríguez-Oroz Francesc Valldeoriola Jaime Kulisevsky |
author_sort |
Javier Pagonabarraga |
title |
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_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_sort |
spanish consensus on the use of safinamide for parkinson’s disease in clinical practice |
publisher |
MDPI AG |
series |
Brain Sciences |
issn |
2076-3425 |
publishDate |
2020-03-01 |
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. |
topic |
safinamide efficacy safety fluctuations dyskinesia rand/ucla appropriateness method |
url |
https://www.mdpi.com/2076-3425/10/3/176 |
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