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Review
. 2020 Mar 18;10(3):176.
doi: 10.3390/brainsci10030176.

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

Javier Pagonabarraga  1   2   3 , José Matías Arbelo  4   5 , Francisco Grandas  6   7 , Maria-Rosario Luquin  8   9 , Pablo Martínez Martín  10   11 , Mari Cruz Rodríguez-Oroz  12   13 , Francesc Valldeoriola  14   15 , Jaime Kulisevsky  1   2   3   16   17
Affiliations
Review

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

Javier Pagonabarraga et al. Brain Sci. .

Erratum in

Abstract

Safinamide is an approved drug for the treatment of 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 ON time without troublesome dyskinesias [corrected]. 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.

Keywords: RAND/UCLA appropriateness method; dyskinesia; efficacy; fluctuations; safety; safinamide.

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Conflict of interest statement

J.P has received honoraria as an advisor from Bial, UCB, Zambon, Allergan and Esteve, and as a speaker from Bial, UCB, Allergan and Zambon. F.G has received honoraria for advisory from Zambon and for lecturing from TEVA, Zambon, Bial and Allergan. M.R.I.L has received honoraria from TEVA, Zambon, AbbVie and Bial for activities unrelated to the work submitted. P.M.M has received honoraria from National School of Public Health (ISCIII) and Editorial Viguera for lecturing in courses; International Parkinson and Movement Disorder Society (IPMDS) for management of the Program on Rating Scales; Abbvie and Zambon for advice in clinical-epidemiological studies. License fee payments for the King’s Parkinson’s Disease Pain Scale. Financial support by the IPMDS for attending the IPMDS International Congress 2019. Grant for Research: IPMDS, for development and validation of the MDS-NMS. M.C.R.O received honoraria for lectures, travel and accommodation to attend scientific meetings from Abbvie, Zambon, and Boston Scientific, Insightec and she received financial support for her research from national and local government bodies in Spain (Institute of Health Carlos III, Basque Country Government, and Navarra Government). F.V has received honoraria as a speaker and advisor from Zambon, Medtronic, Boston’s Scientific and Teva. J.K was a site PI for Clinical Trials for Adamas, Accorda, Abbvie, Biotie and Zambon; Consultancy/Speaker fees from Abbvie, Teva, Zambon, and Bial. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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