2021
DOI: 10.3233/jpd-202224
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A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial1

Abstract: 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… Show more

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Cited by 34 publications
(56 citation statements)
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“…We found safinamide to be well tolerated in real conditions, even when co-administered with antidepressants, which is in consonance with previous reports [ 30 , 32 ]. Overall, the relative frequencies of major and minor symptoms associated with serotonin syndrome were low, without significant differences between the safinamide-only and safinamide + antidepressants groups.…”
Section: Discussionsupporting
confidence: 93%
See 1 more Smart Citation
“…We found safinamide to be well tolerated in real conditions, even when co-administered with antidepressants, which is in consonance with previous reports [ 30 , 32 ]. Overall, the relative frequencies of major and minor symptoms associated with serotonin syndrome were low, without significant differences between the safinamide-only and safinamide + antidepressants groups.…”
Section: Discussionsupporting
confidence: 93%
“…However, two patients withdrew from the treatment due to major symptoms, although they were not severe. Even though safinamide is safe in patients older than 75 years [ 30 ], an advanced age and concomitant treatment with opioids are likely to have played a role in these cases. It is important to explain here that some opioids such as tramadol can inhibit the reuptake of serotonin by inhibiting the serotonin transporter, and therefore, they should also be considered serotonergic drugs [ 33 ].…”
Section: Discussionmentioning
confidence: 99%
“…The results about adverse events are in line with other studies [ 5 , 6 , 7 , 8 , 9 , 10 , 37 , 38 , 39 , 40 , 41 , 46 , 47 , 48 , 50 , 51 , 52 , 53 , 54 ]. With regards to this point, a recent study conducted in 1610 PD patients demonstrated a good safety profile of safinamide even in special groups [ 53 ]. Dyskinesia, as in some studies, was the most frequent adverse event in our study.…”
Section: Discussionsupporting
confidence: 91%
“…This increase was performed in 107 patients due to poor response to the lower dose, indicating that safinamide 100 mg could provide further clinical benefit [39]. In the SYN-APSES ("European multicentre retrospective-prospective cohort StudY to observe safiNAmide safety profile and pattern of use in clinical Practice during the firSt post-commErcialization phaSe") trial, a significant clinical improvement was observed in UPDRS total score (39.0% of responders) and UPDRS-III (45.0% of responders) at 12 months [25,40]. Another observational study on 165 patients with PD showed significant improvements in motor and non-motor experiences of daily living assessed through the Movement Disorder Society-sponsored revision of UPDRS (MDS-UPDRS) part I and II [41].…”
Section: Discussionmentioning
confidence: 99%
“…Similar results were observed in PDwoMF patients at 200 mg, 100 mg, and 50 mg doses, but the quality of the evidence was lower. Recently, the SYNAPSES trial provided further real-world data on safinamide safety [40]. After a 12-month follow-up of 1558 PD patients, 92.2% having motor fluctuations, no differences were observed in the quality of reported AEs.…”
Section: Discussionmentioning
confidence: 99%