RT info:eu-repo/semantics/article
T1 A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial
A1 Abbruzzese, Giovanni
A1 Kulisevsky Bojarsky, Jaume
A1 Bergmansº, Bruno
A1 Gómez Esteban, Juan Carlos
A1 Kägi, Georg
A1 Stefani, Alessandro
A1 Warnecke, Tobias
A1 Jost, Wolfgang H.
A1 Cubo Delgado, Esther
A1 SYNAPSES Study Investigators Group
K1 Parkinson’s disease
K1 Safinamide
K1 MAO-B inhibitor
K1 Real-life evaluation
K1 Sistema nervioso-Enfermedades
K1 Nervous system-Diseases
K1 Medicina
K1 Medicine
K1 Neurología
K1 Neurology
AB 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.
PB IOS Press
SN 1877-7171
YR 2021
FD 2021-02
LK http://hdl.handle.net/10259/8816
UL http://hdl.handle.net/10259/8816
LA eng
DS Repositorio Institucional de la Universidad de Burgos
RD 24-nov-2024