A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial.
- Abbruzzese G DINOGMI, University of Genoa, Genova, 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 & Ghent University Hospital, Ghent, Belgium.
- Gomez-Esteban JC Biocruces Research Institute, Barakaldo, Spain.
- Kägi G Department of Neurology, Cantonal Hospital St.Gallen, Switzerland.
- Raw J Fairfield General Hospital, Bury, Greater Manchester, UK.
- Stefani A Parkinson Center, University Policlinico Tor Vergata, Roma, Italy.
- Warnecke T Department of Neurology, University of Muenster, Muenster, Germany.
- Jost WH Parkinson-Klinik Ortenau, University of Freiburg, Wolfach, Germany.
- 2020-10-26
Published in:
- Journal of Parkinson's disease. - 2020
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.3233/JPD-202224
- PMID 33104040
- Persistent URL
- https://sonar.ch/global/documents/138942
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