2026-10-16T18:41:46Zhttps://riubu.ubu.es/oai/requestoai:riubu.ubu.es:10259/88162024-03-15T01:05:26Zcom_10259_4219com_10259_5086com_10259_2604col_10259_4220
Repositorio Institucional de la Universidad de Burgos
author
Abbruzzese, Giovanni
author
Kulisevsky Bojarsky, Jaume
author
Bergmansº, Bruno
author
Gómez Esteban, Juan Carlos
author
Kägi, Georg
author
Stefani, Alessandro
author
Warnecke, Tobias
author
Jost, Wolfgang H.
author
Cubo Delgado, Esther
author
SYNAPSES Study Investigators Group
2024-03-14T08:10:25Z
2024-03-14T08:10:25Z
2021-02
1877-7171
http://hdl.handle.net/10259/8816
10.3233/JPD-202224
1877-718X
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.
eng
Atribución 4.0 Internacional
Parkinson’s disease
Safinamide
MAO-B inhibitor
Real-life evaluation
A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
info:eu-repo/semantics/article
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URL
https://riubu.ubu.es/bitstream/10259/8816/1/Abbruzzese-jpd_2021.pdf
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Abbruzzese-jpd_2021.pdf