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

G. Abbruzzese*, J. Kulisevsky, B. Bergmans, J. C. Gomez-Esteban, G. Kagi, J. Raw, A. Stefani, T. Warnecke, W. H. Jost, B. Bergmans, P. Bourgeois, P. Cras, N. de Klippel, S. Dethy, G. Franco, G. Garraux, K. Geens, P. Jacquerye, A. Jeanjean, P. SantensF. 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, Anna Rita Bentivoglio, D. Bosco, Paolo 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, Lazzaro V. Di, 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. Volonte, M. Zappia, A. L. Zecchinelli, Gonzalez J. M. Arbelo, A. Bayes, M. Blazquez, Garriga M. Calopa, A. Callen, Arillo V. Campos, E. Cubo, O. de Fabregues, Arroyo S. Escalante, Rosso R. Espinosa, Lopez A. Esquivel, E. Freire, Cobos E. Garcia, Moreno J. M. Garcia, J. C. Gomez-Esteban, J. Gonzalez-Ardura, Perez F. Grandas, J. Kulisevsky, M. Kurtis, J. Juni, I. Legarda, C. Leiva, Aristegui N. Lopez, Manzanares L. Lopez, J. J. Lozano, M. R. Luquin, Castrillo J. C. Martinez, Domenech M. J. Marti, I. Martinez, M. Mata, Rivera P. Mir, Sedano B. Pascual, Oroz M. C. Rodriguez, Uranga J. J. Rodriguez, S. Sanchez, Garcia D. Santos, B. Solano, Gamo J. Vaamonde, E. Accolla, S. Bohlhalter, A. Kalin, G. Kagi, J. Michelis, C. Carrol, E. Henderson, S. Raha, J. Raw, N. Silva, M. Silverdale

*Autore corrispondente per questo lavoro

Risultato della ricerca: Contributo in rivistaArticolo

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 originaleInglese
pagine (da-a)187-198
Numero di pagine12
RivistaJournal of Parkinson's Disease
Volume11
Numero di pubblicazione1
DOI
Stato di pubblicazionePubblicato - 2021

All Science Journal Classification (ASJC) codes

  • Neurologia (clinica)
  • Neuroscienze Cellulari e Molecolari

Keywords

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

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