Objective: To evaluate clinical effects, safety and tolerability of safinamide add-on levodopa in Parkinson’s disease (PD) patients.

Background: Safinamide is a recently approved adjunctive treatment to levodopa/carbidopa in PD patients with motor fluctuations. Several studies have shown that safinamide elicits a significant reduction of daily OFF time without increasing the intensity of dyskinesias. In addition, post-hoc analyses have suggested that it might also improve non-motor symptoms, probably due to its dual mechanism of action (reversible inhibition of MAO-B enzyme and modulation of glutamate release).

Methods: Observational, retrospective-prospective, multicenter cohort study that included PD patients who started safinamide according to clinical practice. Demographic and clinical data were recollected. Clinical effect was assessed with a Clinical Global Impression Improvement Scale(CGI-I) asking separately for motor and non-motor symptoms. In addition, the effect on dyskinesia and presence of adverse events(AE) were also reported.

Results: 214 PD patients (117 men, mean age 66.7 years (±10.3), mean disease duration of 8.3 years (±4.9) and mean mH&Y score 2.5(±0.7) who started safinamide between Feb. 2016 and Nov. 2017 were recruited. Clinical characteristics of PD patients are shown in table 1. In the follow-up visit CGI-I was assessed. Regarding motor symptoms 66.3% improved, 23.3% referred no changes and 10.3% worsened at their motor symptoms. Non-motor CGI-I was assessed in 3 out of 4 centers (total 154 patients). 75.9% described some improvement, 20.8% referred no changes and 3.2% worsened. Dyskinesias were not modified in 183 (85.5%) patients, mild worsening was observed in 14(6.5%), moderate worsening in 10(4.6%) and improvement in 7(3.2%). AE were reported in 47 patients (21.9%) being the most frequent dizziness-nausea (14%), gait instability (7.9%) and confusion(4.7%). Statistical analysis did not show any clinical data associated with clinical improvement after starting safinamide. However, AE were associated with previous falls, cognitive impairment and concomitant treatment with antidepressants and/or antipsychotics (OR 3.62, p<0.037, OR 8.48, p<0.001, OR 4.02, p<0.003 respectively).

Conclusions: Our results indicate that safinamide provides a significant motor improvement in advance PD, assessed by CGI scales with no increase in the intensity of dyskinesias. Although it does not induce important AE, it should be administered with caution in PD patients with falls, cognitive impairment and in those who are receiving concomitant treatments with antidepressant and antipsychotic.

References: (1)-Fabbri M, Rosa MM, Abreu D, Ferreira JJ. Clinical pharmacology review of safinamide for the treatment of Parkinson’s disease. Neurodegener Dis Manag. 2015;5:481–496. (2)-Cattaneo, Carlo. (2016). Safinamide as Add-On Therapy to Levodopa in Mid-to Late-Stage Parkinson’s Disease Fluctuating Patients: Post hoc Analyses of Studies 016 and SETTLE. Journal of Parkinson’s Disease. 6. 165-173.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safinamide-in-parkinsons-disease/