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

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

doi:10.3233/JPD-202224

Article (Scientific journals)

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

Abbruzzese, G.; Kulisevsky, J.; Bergmans, B. et al.

2021 • In Journal of Parkinson's Disease, 11 (1), p. 187 - 198

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/333527

DOI
10.3233/JPD-202224

PubMed
33104040

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Keywords :

MAO-B inhibitor; Parkinson's disease; Real-life evaluation; Safinamide; safinamide; alanine; benzylamine derivative; monoamine oxidase inhibitor; aged; aging; Article; benign neoplasm; blurred vision; breast disease; clinical practice; cohort analysis; comorbidity; connective tissue disease; constipation; diplopia; drug efficacy; drug safety; dyskinesia; endocrine disease; Europe; female; femur fracture; follow up; hallucination; headache; heart disease; hepatobiliary disease; human; infection; infestation; inner ear disease; intoxication; lymphatic system disease; major clinical study; male; malignant neoplasm; mediastinum disease; mental disease; metabolic disorder; multicenter study; nutritional disorder; observational study; Parkinson disease; patient information; pneumonia; priority journal; prospective study; reproductive toxicity; retrospective study; skin disease; thorax disease; Unified Parkinson Disease Rating Scale; urinary tract infection; vascular disease; adverse drug reaction; clinical trial; middle aged; pathophysiology; very elderly; Aged; Aged, 80 and over; Alanine; Benzylamines; Comorbidity; Drug-Related Side Effects and Adverse Reactions; Female; Follow-Up Studies; Humans; Male; Mental Disorders; Middle Aged; Monoamine Oxidase Inhibitors; Outcome Assessment, Health Care; Parkinson Disease; Retrospective Studies

Abstract :

[en] 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. © 2021 - The authors. Published by IOS Press.

Disciplines :

Neurology

Author, co-author :

Abbruzzese, G.; DINOGMI, University of Genoa, Genova, Italy, Italy

Kulisevsky, J.; Sant Pau Hospital, Universitat Autònoma de Barcelona, CIBERNED, Barcelona, Spain

Bergmans, B.; Department of Neurology, AZ St-Jan Brugge-Oostende AV, Campus Brugge, Brugge and Ghent University Hospital, Ghent, Belgium, Belgium

Gomez-Esteban, J.C.; Biocruces Research Institute, Barakaldo, Spain, Spain

Kägi, G.; Department of Neurology, Cantonal Hospital St.Gallen, Switzerland, Switzerland

Raw, J.; Fairfield General Hospital, Bury, Greater Manchester, United Kingdom, United Kingdom

Stefani, A.; Parkinson Center, University Policlinico Tor Vergata, Roma, Italy

Warnecke, T.; Department of Neurology, University of Muenster, Muenster, Germany

Jost, W.H.; Parkinson-Klinik Ortenau, University of Freiburg, Wolfach, Germany, Germany

Bergmans, B.; Department of Neurology, AZ St-Jan Brugge-Oostende AV, Campus Brugge, Brugge and Ghent University Hospital, Ghent, Belgium, Belgium

More authors (128 more)

Language :

English

Title :

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

Publication date :

2021

Journal title :

Journal of Parkinson's Disease

ISSN :

1877-7171

eISSN :

1877-718X

Publisher :

IOS Press BV

Volume :

Issue :

Pages :

187 - 198

Peer reviewed :

Peer Reviewed verified by ORBi

Funding text :

The authors thank the investigators and the patients involved in the trial. The study was funded by Zambon S.p.A.

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