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Real-world use of Safinamide in motor fluctuating Parkinson’s disease patients in Italy

2023; Springer Science+Business Media; Linguagem: Inglês

10.1007/s10072-023-07001-6

1590-3478

Roberta Bovenzi, Claudio Liguori, Margherita Canesi, Marco D’Amelio, Maria Francesca De Pandis, Carmine Marini, A. Monge, Alessandro Padovani, Alessandro Tessitore, Ambra Stefani, Mario Zappia, Giovanni Abbruzzese, Marco Aguggia, Tania P. Avarello, Paolo Barone, Anna Rita Bentivoglio, Daryl A. Bosco, Paolo Calabresi, C. Callegarini, Antonino Cannas, Diego Centonze, Roberto Ceravolo, Carlo Colosimo, Cristoforo Comi, Sara Contardi, Pietro Cortelli, Giovanni Cossu, Vincenzo Di Lazzaro, Roberto Eleopra, Giovanni Fabbrini, Elisabetta Gasparoli, Marco Guidi, Giovanni Iliceto, Leonardo Lopiano, Paolo Manganotti, R. Marconi, M. Mauri, Massimo Moleri, Francesca Morgante, Anna Negrotti, Giampietro Nordera, Marco Onofrj, Claudio Pacchetti, Francesco E. Pontieri, Alberto Priori, Leandro Provinciali, R. Quatrale, Mariachiara Sensi, Francesca Spagnolo, Filippo Tamma, Michèle Tinazzi, Carolina Vitale, Maria Antonietta Volonté, Sandro Zambito Marsala,

Restless Legs Syndrome Research

Abstract Introduction Safinamide is a recent antiparkinsonian drug that modulates both dopaminergic and glutamatergic systems with positive effects on motor and nonmotor symptoms of Parkinson’s disease (PD). Here, we aimed to describe the efficacy and safety of safinamide in the Italian PD patients in real-life conditions. Methods We performed a sub-analysis of the Italian cohort of the SYNAPSES study, a multi-country, multi-center, retrospective-prospective cohort observational study, designed to investigate the use of safinamide in routine clinical practice. Patients received for the first time a treatment with safinamide and were followed up for 12 months. The analysis was conducted on the overall population and in subgroups of interest: i) patients > 75 years, ii) patients with relevant comorbidities and iii) patients affected by psychiatric symptoms. Results Italy enrolled 616/1610 patients in 52 centers, accounting for 38% of the entire SYNAPSES cohort. Of the patients enrolled, 86.0% were evaluable at 12 months, with 23.3% being > 75 years, 42.4% with psychiatric conditions and 67.7% with relevant comorbidities. Safinamide was effective on motor symptoms and fluctuations as measured through the Unified PD rating scale III and IV scores, and on the total score, without safety issues in none of the subgroups considered. Conclusion The SYNAPSES data related to Italian patients confirms the good safety profile of safinamide even in special groups of patients. Motor fluctuations and motor impairment improved at the follow-up suggesting the significant role of safinamide in managing motor symptoms in PD patients.