A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice : The SYNAPSES Trial
Abbruzzese, Giovanni (University of Genoa)
Kulisevsky, Jaime (Institut d'Investigació Biomèdica Sant Pau)
Bergmans, Bruno (Universitair Ziekenhuis Gent)
Gomez-Esteban, Juan C. (Instituto de Investigación Sanitaria Biocruces Bizkaia)
Kägi, Georg (Cantonal Hospital St.Gallen)
Raw, Jason (Fairfield General Hospital)
Stefani, Alessandro (University Policlinico Tor Vergata)
Warnecke, Tobias (University of Muenster)
Jost, Wolfgang H. (University of Freiburg)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	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. To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. 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. 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. 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Parkinson's disease ; Safinamide ; MAO-B inhibitor ; Real-life evaluation
Publicat a:	Journal of Parkinson's Disease, Vol. 11 (february 2021) , p. 187-198, ISSN 1877-718X

DOI: 10.3233/JPD-202224
PMID: 33104040

12 p, 501.8 KB

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