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Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study

Safinamide is a selective, reversible, monoamine oxidase B inhibitor for the treatment of patients with Parkinson's disease (PD) and motor fluctuations. This was a post hoc analysis of the SETTLE study, in which patients with PD and motor fluctuations were randomly assigned to 24-week treatment...

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Autores principales: Bhidayasiri, Roongroj, Koebis, Michinori, Kamei, Takanori, Ishida, Takayuki, Suzuki, Ippei, Cho, Jin Whan, Wu, Shey-Lin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083404/
https://www.ncbi.nlm.nih.gov/pubmed/37051060
http://dx.doi.org/10.3389/fneur.2023.1147008
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author Bhidayasiri, Roongroj
Koebis, Michinori
Kamei, Takanori
Ishida, Takayuki
Suzuki, Ippei
Cho, Jin Whan
Wu, Shey-Lin
author_facet Bhidayasiri, Roongroj
Koebis, Michinori
Kamei, Takanori
Ishida, Takayuki
Suzuki, Ippei
Cho, Jin Whan
Wu, Shey-Lin
author_sort Bhidayasiri, Roongroj
collection PubMed
description Safinamide is a selective, reversible, monoamine oxidase B inhibitor for the treatment of patients with Parkinson's disease (PD) and motor fluctuations. This was a post hoc analysis of the SETTLE study, in which patients with PD and motor fluctuations were randomly assigned to 24-week treatment with safinamide (50 mg/day for 2 weeks, increased to 100 mg/day if tolerated) or placebo. In the present analysis, responders were defined according to their treatment responses at Week 2 and Week 24 based on changes in ON-time without troublesome dyskinesia from baseline with cutoffs of 1 hour. It was found that 81% (103/127) of the responders at Week 2 maintained the response through Week 24 in the safinamide group. Other outcomes did not necessarily coincide with the ON-time response; however, “Early” responders who showed a treatment response at both Week 2 and Week 24 had substantial improvements from baseline in OFF-time, UPDRS Part II and III scores, and PDQ-39 summary index scores through Week 24. The safinamide group had a higher proportion of early responders than the placebo group (39% vs 20%, p < 0.0001). At baseline, early responders in the safinamide group had significantly higher UPDRS Part II and III scores, shorter ON-time, and longer OFF-time than the other responder populations. In conclusion, the results of the present post hoc analysis suggest that patients with a short ON-time, severe motor symptoms, and highly compromised activities of daily living can benefit from safinamide early in treatment and over the long term.
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spelling pubmed-100834042023-04-11 Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study Bhidayasiri, Roongroj Koebis, Michinori Kamei, Takanori Ishida, Takayuki Suzuki, Ippei Cho, Jin Whan Wu, Shey-Lin Front Neurol Neurology Safinamide is a selective, reversible, monoamine oxidase B inhibitor for the treatment of patients with Parkinson's disease (PD) and motor fluctuations. This was a post hoc analysis of the SETTLE study, in which patients with PD and motor fluctuations were randomly assigned to 24-week treatment with safinamide (50 mg/day for 2 weeks, increased to 100 mg/day if tolerated) or placebo. In the present analysis, responders were defined according to their treatment responses at Week 2 and Week 24 based on changes in ON-time without troublesome dyskinesia from baseline with cutoffs of 1 hour. It was found that 81% (103/127) of the responders at Week 2 maintained the response through Week 24 in the safinamide group. Other outcomes did not necessarily coincide with the ON-time response; however, “Early” responders who showed a treatment response at both Week 2 and Week 24 had substantial improvements from baseline in OFF-time, UPDRS Part II and III scores, and PDQ-39 summary index scores through Week 24. The safinamide group had a higher proportion of early responders than the placebo group (39% vs 20%, p < 0.0001). At baseline, early responders in the safinamide group had significantly higher UPDRS Part II and III scores, shorter ON-time, and longer OFF-time than the other responder populations. In conclusion, the results of the present post hoc analysis suggest that patients with a short ON-time, severe motor symptoms, and highly compromised activities of daily living can benefit from safinamide early in treatment and over the long term. Frontiers Media S.A. 2023-03-27 /pmc/articles/PMC10083404/ /pubmed/37051060 http://dx.doi.org/10.3389/fneur.2023.1147008 Text en Copyright © 2023 Bhidayasiri, Koebis, Kamei, Ishida, Suzuki, Cho and Wu. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Bhidayasiri, Roongroj
Koebis, Michinori
Kamei, Takanori
Ishida, Takayuki
Suzuki, Ippei
Cho, Jin Whan
Wu, Shey-Lin
Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study
title Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study
title_full Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study
title_fullStr Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study
title_full_unstemmed Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study
title_short Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study
title_sort sustained response in early responders to safinamide in patients with parkinson's disease and motor fluctuations: a post hoc analysis of the settle study
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10083404/
https://www.ncbi.nlm.nih.gov/pubmed/37051060
http://dx.doi.org/10.3389/fneur.2023.1147008
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