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

1
Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain
2
Department of Medicine, Autonomous University of Barcelona, 08193 Barcelona, Spain
3
Centro de Investigación en Red sobre Enfermedades Neurodegenerativas (CIBERNED), 28031 Madrid, Spain
4
Movement Disorders Unit, Neurology Department, Hospital Universitario San Roque, 35001 Las Palmas, Spain
5
Department of Medicine, Universidad Fernando Pessoa-Canarias, 35450 Las Palmas, Spain
6
Movement Disorders Unit-CSUR, Neurology Department, Hospital General Universitario Gregorio Marañón, 28007 Madrid, Spain
7
Department of Medicine, Universidad Complutense de Madrid, 28040 Madrid, Spain
8
Movement Disorders Unit, Clínica Universidad de Navarra (CUN), 31008 Pamplona, Spain
9
Navarra Institute for Health Research (IdiSNA), 31008 Pamplona, Spain
10
Instituto de Salud Carlos III, 28029 Madrid, Spain
11
Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), 28031 Madrid, Spain
12
Neurology and Neuroscience Unit, Clínica Universidad de Navarra (CUN), 31008Pamplona, Spain
13
Centre for Applied Medical Research (CIMA), 31008 Pamplona, Spain
14
Neurosciences Institut, Hospital Clinic de Barcelona, 08036 Barcelona, Spain
15
Department of Medicine, Universitat de Barcelona, 08036 Barcelona, Spain
16
Biomedical Research Institute (IIB-Sant Pau), 08041 Barcelona, Spain
17
Department of Medicine, Universitat Oberta de Catalunya, 08018 Barcelona, Spain
*
Author to whom correspondence should be addressed.
Brain Sci. 2020, 10(3), 176; https://doi.org/10.3390/brainsci10030176
Received: 7 February 2020 / Revised: 15 March 2020 / Accepted: 16 March 2020 / Published: 18 March 2020
(This article belongs to the Special Issue Frontiers in Parkinson’s Disease (PD))
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. View Full-Text
Keywords: safinamide; efficacy; safety; fluctuations; dyskinesia; RAND/UCLA appropriateness method safinamide; efficacy; safety; fluctuations; dyskinesia; RAND/UCLA appropriateness method
MDPI and ACS Style

Pagonabarraga, J.; Arbelo, J.M.; Grandas, F.; Luquin, M.-R.; Martínez Martín, P.; Rodríguez-Oroz, M.C.; Valldeoriola, F.; Kulisevsky, J. A Spanish Consensus on the Use of Safinamide for Parkinson’s Disease in Clinical Practice. Brain Sci. 2020, 10, 176.

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