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Observational Study
. 2024 Feb;45(2):573-583.
doi: 10.1007/s10072-023-07001-6. Epub 2023 Sep 9.

Real-world use of Safinamide in motor fluctuating Parkinson's disease patients in Italy

Roberta Bovenzi  1 , Claudio Liguori  2   3 , Margherita Canesi  4   5 , Marco D'Amelio  6 , Maria Francesca De Pandis  7   8 , Carmine Marini  9 , Alessandra Monge  10 , Alessandro Padovani  11 , Alessandro Tessitore  12 , Alessandro Stefani  1   13 , Mario Zappia  14 ; SYNAPSES Study Investigators Italian Group
Collaborators, Affiliations
Observational Study

Real-world use of Safinamide in motor fluctuating Parkinson's disease patients in Italy

Roberta Bovenzi et al. Neurol Sci. 2024 Feb.

Abstract

Introduction: Safinamide is a recent antiparkinsonian drug that modulates both dopaminergic and glutamatergic systems with positive effects on motor and nonmotor symptoms of Parkinson's disease (PD). Here, we aimed to describe the efficacy and safety of safinamide in the Italian PD patients in real-life conditions.

Methods: We performed a sub-analysis of the Italian cohort of the SYNAPSES study, a multi-country, multi-center, retrospective-prospective cohort observational study, designed to investigate the use of safinamide in routine clinical practice. Patients received for the first time a treatment with safinamide and were followed up for 12 months. The analysis was conducted on the overall population and in subgroups of interest: i) patients > 75 years, ii) patients with relevant comorbidities and iii) patients affected by psychiatric symptoms.

Results: Italy enrolled 616/1610 patients in 52 centers, accounting for 38% of the entire SYNAPSES cohort. Of the patients enrolled, 86.0% were evaluable at 12 months, with 23.3% being > 75 years, 42.4% with psychiatric conditions and 67.7% with relevant comorbidities. Safinamide was effective on motor symptoms and fluctuations as measured through the Unified PD rating scale III and IV scores, and on the total score, without safety issues in none of the subgroups considered.

Conclusion: The SYNAPSES data related to Italian patients confirms the good safety profile of safinamide even in special groups of patients. Motor fluctuations and motor impairment improved at the follow-up suggesting the significant role of safinamide in managing motor symptoms in PD patients.

Keywords: MAO-B inhibitor; Parkinson’s disease; Real-life evaluation; Safety; Safinamide.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Fluctuations during observation in the overall population (baseline, 4, 8, 12 months). WO, wearing-OFF; m, month; start, baseline
Fig. 2
Fig. 2
UPDRS I-IV score changes during the trial (baseline, 4, 8, 12 months). m, month
See this image and copyright information in PMC

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