Real-world use of Safinamide in motor fluctuating Parkinson's disease patients in Italy
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:45 |
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| Enthalten in: |
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology - 45(2024), 2 vom: 01. Feb., Seite 573-583 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bovenzi, Roberta [VerfasserIn] |
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| Links: |
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| Themen: |
46627O600J |
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| Anmerkungen: |
Date Completed 18.01.2024 Date Revised 07.02.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s10072-023-07001-6 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM361820038 |
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| 100 | 1 | |a Bovenzi, Roberta |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Real-world use of Safinamide in motor fluctuating Parkinson's disease patients in Italy |
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| 500 | |a Date Completed 18.01.2024 | ||
| 500 | |a Date Revised 07.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a MAO-B inhibitor | |
| 650 | 4 | |a Parkinson’s disease | |
| 650 | 4 | |a Real-life evaluation | |
| 650 | 4 | |a Safety | |
| 650 | 4 | |a Safinamide | |
| 650 | 7 | |a safinamide |2 NLM | |
| 650 | 7 | |a 90ENL74SIG |2 NLM | |
| 650 | 7 | |a Antiparkinson Agents |2 NLM | |
| 650 | 7 | |a Alanine |2 NLM | |
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| 650 | 7 | |a Levodopa |2 NLM | |
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| 650 | 7 | |a Benzylamines |2 NLM | |
| 700 | 1 | |a Liguori, Claudio |e verfasserin |4 aut | |
| 700 | 1 | |a Canesi, Margherita |e verfasserin |4 aut | |
| 700 | 1 | |a D'Amelio, Marco |e verfasserin |4 aut | |
| 700 | 1 | |a De Pandis, Maria Francesca |e verfasserin |4 aut | |
| 700 | 1 | |a Marini, Carmine |e verfasserin |4 aut | |
| 700 | 1 | |a Monge, Alessandra |e verfasserin |4 aut | |
| 700 | 1 | |a Padovani, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Tessitore, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Stefani, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Zappia, Mario |e verfasserin |4 aut | |
| 700 | 0 | |a SYNAPSES Study Investigators Italian Group |e verfasserin |4 aut | |
| 700 | 1 | |a Abbruzzese, G |e investigator |4 oth | |
| 700 | 1 | |a Aguggia, M |e investigator |4 oth | |
| 700 | 1 | |a Avarello, T |e investigator |4 oth | |
| 700 | 1 | |a Barone, P |e investigator |4 oth | |
| 700 | 1 | |a Bentivoglio, A R |e investigator |4 oth | |
| 700 | 1 | |a Bosco, D |e investigator |4 oth | |
| 700 | 1 | |a Calabresi, P |e investigator |4 oth | |
| 700 | 1 | |a Callegarini, C |e investigator |4 oth | |
| 700 | 1 | |a Cannas, A |e investigator |4 oth | |
| 700 | 1 | |a Centonze, D |e investigator |4 oth | |
| 700 | 1 | |a Ceravolo, R |e investigator |4 oth | |
| 700 | 1 | |a Colosimo, C |e investigator |4 oth | |
| 700 | 1 | |a Comi, C |e investigator |4 oth | |
| 700 | 1 | |a Contardi, S |e investigator |4 oth | |
| 700 | 1 | |a Cortelli, P |e investigator |4 oth | |
| 700 | 1 | |a Cossu, G |e investigator |4 oth | |
| 700 | 1 | |a Di Lazzaro, V |e investigator |4 oth | |
| 700 | 1 | |a Eleopra, R |e investigator |4 oth | |
| 700 | 1 | |a Fabbrini, G |e investigator |4 oth | |
| 700 | 1 | |a Gasparoli, E |e investigator |4 oth | |
| 700 | 1 | |a Guidi, M |e investigator |4 oth | |
| 700 | 1 | |a Iliceto, G |e investigator |4 oth | |
| 700 | 1 | |a Lopiano, L |e investigator |4 oth | |
| 700 | 1 | |a Manganotti, P |e investigator |4 oth | |
| 700 | 1 | |a Marconi, R |e investigator |4 oth | |
| 700 | 1 | |a Mauri, M |e investigator |4 oth | |
| 700 | 1 | |a Moleri, M |e investigator |4 oth | |
| 700 | 1 | |a Morgante, F |e investigator |4 oth | |
| 700 | 1 | |a Negrotti, A |e investigator |4 oth | |
| 700 | 1 | |a Nordera, G |e investigator |4 oth | |
| 700 | 1 | |a Onofrj, M |e investigator |4 oth | |
| 700 | 1 | |a Pacchetti, C |e investigator |4 oth | |
| 700 | 1 | |a Pontieri, F E |e investigator |4 oth | |
| 700 | 1 | |a Priori, A |e investigator |4 oth | |
| 700 | 1 | |a Provinciali, L |e investigator |4 oth | |
| 700 | 1 | |a Quatrale, R |e investigator |4 oth | |
| 700 | 1 | |a Sensi, M |e investigator |4 oth | |
| 700 | 1 | |a Spagnolo, F |e investigator |4 oth | |
| 700 | 1 | |a Tamma, F |e investigator |4 oth | |
| 700 | 1 | |a Tinazzi, M |e investigator |4 oth | |
| 700 | 1 | |a Vitale, C |e investigator |4 oth | |
| 700 | 1 | |a Volontè, M A |e investigator |4 oth | |
| 700 | 1 | |a Zambito Marsala, S |e investigator |4 oth | |
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