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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Frontiers Media S.A.
2023-03-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2023.1147008/full |
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| author | Roongroj Bhidayasiri Roongroj Bhidayasiri Michinori Koebis Takanori Kamei Takayuki Ishida Ippei Suzuki Jin Whan Cho Jin Whan Cho Shey-Lin Wu |
| author_facet | Roongroj Bhidayasiri Roongroj Bhidayasiri Michinori Koebis Takanori Kamei Takayuki Ishida Ippei Suzuki Jin Whan Cho Jin Whan Cho Shey-Lin Wu |
| author_sort | Roongroj Bhidayasiri |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-09T21:33:54Z |
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| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-04-09T21:33:54Z |
| publishDate | 2023-03-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Neurology |
| spelling | doaj.art-91ff4762aea546c5bdb9644f1cee3f152023-03-27T05:23:39ZengFrontiers Media S.A.Frontiers in Neurology1664-22952023-03-011410.3389/fneur.2023.11470081147008Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE studyRoongroj Bhidayasiri0Roongroj Bhidayasiri1Michinori Koebis2Takanori Kamei3Takayuki Ishida4Ippei Suzuki5Jin Whan Cho6Jin Whan Cho7Shey-Lin Wu8Chulalongkorn Centre of Excellence for Parkinson's Disease and Related Disorders, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, ThailandThe Academy of Science, The Royal Society of Thailand, Bangkok, ThailandMedical Headquarters, Eisai Co., Ltd., Tokyo, JapanMedical Headquarters, Eisai Co., Ltd., Tokyo, JapanMedical Headquarters, Eisai Co., Ltd., Tokyo, JapanClinical Evidence Generation Fulfillment, Deep Human Biology Learning, Eisai Co., Ltd., Tokyo, JapanDepartment of Neurology, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaNeuroscience Center, Samsung Medical Center, Seoul, Republic of KoreaDepartment of Neurology, Changhua Christian Hospital, Changhua, TaiwanSafinamide 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.https://www.frontiersin.org/articles/10.3389/fneur.2023.1147008/fullsafinamideParkinson's diseaselevodopamonoamine oxidase B inhibitormotor fluctuationpost hoc analysis |
| spellingShingle | Roongroj Bhidayasiri Roongroj Bhidayasiri Michinori Koebis Takanori Kamei Takayuki Ishida Ippei Suzuki Jin Whan Cho Jin Whan Cho Shey-Lin Wu Sustained response in early responders to safinamide in patients with Parkinson's disease and motor fluctuations: A post hoc analysis of the SETTLE study Frontiers in Neurology safinamide Parkinson's disease levodopa monoamine oxidase B inhibitor motor fluctuation post hoc analysis |
| 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 | safinamide Parkinson's disease levodopa monoamine oxidase B inhibitor motor fluctuation post hoc analysis |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2023.1147008/full |
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