A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: The SynapSES trial

Anna Rita Bentivoglio, Paolo Calabresi, Giovanni Abbruzzese, Jaime Kulisevsky, Bruno Bergmans, Juan C. Gomez-Esteban, Georg Kägi, Jason Raw, Alessandro Stefani, Tobias Warnecke, Wolfgang H. Jost, B. Bergmans, P. Bourgeois, P. Cras, N. De Klippel, S. Dethy, G. Franco, G. Garraux, K. Geens, P. JacqueryeA. Jeanjean, P. Santens, F. Supiot, C. Van Der Linden, W. K. Blersch, M. Delf, B. Hellwig, H. P. Herbst, A. Kupsch, W. H. Jost, M. Lang, S. Muhlack, I. Nastos, C. Oehlwein, E. Schlegel, J. Schwarz, T. Warnecke, D. Woitalla, G. Abbruzzese, M. Aguggia, T. Avarello, P. Barone, R. Baruffaldi, E. Belgrado, A. R. Bentivoglio, D. Bosco, P. Calabresi, C. Callegarini, A. Cannas, D. Centonze, R. Ceravolo, C. Colosimo, C. Comi, S. Contardi, P. Cortelli, G. Cossu, M. D'Amelio, M. F. De Pandis, A. Denaro, V. Di Lazzaro, G. Fabbrini, E. Gasparoli, M. Guidi, G. Iliceto, L. Lopiano, P. Manganotti, R. Marconi, C. Marini, S. Z. Marsala, M. Mauri, M. Moleri, A. Monge, F. Morgante, A. Negrotti, G. Nordera, M. Onofrj, C. Pacchetti, A. Padovani, F. E. Pontieri, A. Priori, R. Quatrale, M. Sensi, A. Stefani, F. Tamma, A. Tessitore, M. Tinazzi, C. Vitale, M. A. Volontè, M. Zappia, A. L. Zecchinelli, J. M. Arbelo Gonzalez, A. Bayés, M. Blazquez, M. Calopa Garriga, A. Callen, V. Campos Arillo, E. Cubo, O. De Fábregues, S. Escalante Arroyo, R. Espinosa Rosso, A. Esquivel López, E. Freire, E. García Cobos, J. M. García Moreno, J. C. Gomez-Esteban, J. González-Ardura, F. Grandas Perez, J. Kulisevsky, M. Kurtis, J. Juni, I. Legarda, C. Leiva, N. López Aristegui, L. López Manzanares, J. J. Lozano, M. R. Luquín, J. C. Martinez Castrillo, M. J. Martí Domenech, I. Martínez, M. Mata, P. Mir Rivera, B. Pascual Sedano, M. C. Rodríguez Oroz, J. J. Rodríguez Uranga, S. Sanchez, D. Santos García, B. Solano, J. Vaamonde Gamo, E. Accolla, S. Bohlhalter, A. Kälin, G. Kägi, J. Michelis, C. Carrol, E. Henderson, S. Raha, J. Raw, N. Silva, M. Silverdale

Risultato della ricerca: Contributo in rivistaArticolo in rivista

Abstract

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in ≥40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.
Lingua originaleEnglish
pagine (da-a)187-198
Numero di pagine12
RivistaJournal of Parkinson's Disease
Volume11
DOI
Stato di pubblicazionePubblicato - 2021

Keywords

  • Aged
  • Aged, 80 and over
  • Alanine
  • Benzylamines
  • Comorbidity
  • Drug-Related Side Effects and Adverse Reactions
  • Europe
  • Female
  • Follow-Up Studies
  • Humans
  • MAO-B inhibitor
  • Male
  • Mental Disorders
  • Middle Aged
  • Monoamine Oxidase Inhibitors
  • Outcome Assessment, Health Care
  • Parkinson Disease
  • Parkinson's disease
  • Real-life evaluation
  • Retrospective Studies
  • Safinamide

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