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Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS

BACKGROUND: While immediate benefits of levodopa–carbidopa intestinal gel (LCIG) are evident in patients with Parkinson’s disease (PD), long-term LCIG effects require further study. OBJECTIVES: We explored long-term LCIG on motor symptoms, nonmotor symptoms (NMS), and LCIG treatment settings in pati...

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Autores principales: Fasano, Alfonso, García-Ramos, Rocío, Gurevich, Tanya, Jech, Robert, Bergmann, Lars, Sanchez-Soliño, Olga, Parra, Juan Carlos, Simu, Mihaela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10130122/
https://www.ncbi.nlm.nih.gov/pubmed/36802031
http://dx.doi.org/10.1007/s00415-023-11615-3
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author Fasano, Alfonso
García-Ramos, Rocío
Gurevich, Tanya
Jech, Robert
Bergmann, Lars
Sanchez-Soliño, Olga
Parra, Juan Carlos
Simu, Mihaela
author_facet Fasano, Alfonso
García-Ramos, Rocío
Gurevich, Tanya
Jech, Robert
Bergmann, Lars
Sanchez-Soliño, Olga
Parra, Juan Carlos
Simu, Mihaela
author_sort Fasano, Alfonso
collection PubMed
description BACKGROUND: While immediate benefits of levodopa–carbidopa intestinal gel (LCIG) are evident in patients with Parkinson’s disease (PD), long-term LCIG effects require further study. OBJECTIVES: We explored long-term LCIG on motor symptoms, nonmotor symptoms (NMS), and LCIG treatment settings in patients with advanced PD (APD). METHODS: Data were obtained (medical records and patient visit) from COSMOS, a multinational, retrospective, cross-sectional post-marketing observational study in patients with APD. Patients were stratified into 5 groups based on LCIG treatment duration at the patient visit, from 1–2 to > 5 years LCIG. Between-group differences were assessed for changes from baseline in LCIG settings, motor symptoms, NMS, add-on medications, and safety. RESULTS: Out of 387 patients, the number of patients per LCIG group was: > 1– ≤ 2 years LCIG (n = 156); > 2– ≤ 3 years LCIG (n = 80); > 3– ≤ 4 years LCIG (n = 61); > 4– ≤ 5 years LCIG (n = 30); > 5 years LCIG (n = 60). Baseline values were similar; data reported are changes from the baseline. There were reductions in “off” time, dyskinesia duration, and severity across LCIG groups. Prevalence, severity, and frequency of many individual motor symptoms and some NMS were reduced amongst all LCIG groups, with few differences between groups. Doses for LCIG, LEDD and LEDD for add-on medications were similar across groups both at LCIG initiation and patient visit. Adverse events were similar across all LCIG groups and consistent with the established safety profile of LCIG. CONCLUSIONS: LCIG may provide sustained, long-term symptom control, while potentially avoiding increases in add-on medication dosages. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03362879. Number and date: P16-831, November 30, 2017. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00415-023-11615-3.
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spelling pubmed-101301222023-04-27 Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS Fasano, Alfonso García-Ramos, Rocío Gurevich, Tanya Jech, Robert Bergmann, Lars Sanchez-Soliño, Olga Parra, Juan Carlos Simu, Mihaela J Neurol Original Communication BACKGROUND: While immediate benefits of levodopa–carbidopa intestinal gel (LCIG) are evident in patients with Parkinson’s disease (PD), long-term LCIG effects require further study. OBJECTIVES: We explored long-term LCIG on motor symptoms, nonmotor symptoms (NMS), and LCIG treatment settings in patients with advanced PD (APD). METHODS: Data were obtained (medical records and patient visit) from COSMOS, a multinational, retrospective, cross-sectional post-marketing observational study in patients with APD. Patients were stratified into 5 groups based on LCIG treatment duration at the patient visit, from 1–2 to > 5 years LCIG. Between-group differences were assessed for changes from baseline in LCIG settings, motor symptoms, NMS, add-on medications, and safety. RESULTS: Out of 387 patients, the number of patients per LCIG group was: > 1– ≤ 2 years LCIG (n = 156); > 2– ≤ 3 years LCIG (n = 80); > 3– ≤ 4 years LCIG (n = 61); > 4– ≤ 5 years LCIG (n = 30); > 5 years LCIG (n = 60). Baseline values were similar; data reported are changes from the baseline. There were reductions in “off” time, dyskinesia duration, and severity across LCIG groups. Prevalence, severity, and frequency of many individual motor symptoms and some NMS were reduced amongst all LCIG groups, with few differences between groups. Doses for LCIG, LEDD and LEDD for add-on medications were similar across groups both at LCIG initiation and patient visit. Adverse events were similar across all LCIG groups and consistent with the established safety profile of LCIG. CONCLUSIONS: LCIG may provide sustained, long-term symptom control, while potentially avoiding increases in add-on medication dosages. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03362879. Number and date: P16-831, November 30, 2017. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00415-023-11615-3. Springer Berlin Heidelberg 2023-02-18 2023 /pmc/articles/PMC10130122/ /pubmed/36802031 http://dx.doi.org/10.1007/s00415-023-11615-3 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Communication
Fasano, Alfonso
García-Ramos, Rocío
Gurevich, Tanya
Jech, Robert
Bergmann, Lars
Sanchez-Soliño, Olga
Parra, Juan Carlos
Simu, Mihaela
Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS
title Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS
title_full Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS
title_fullStr Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS
title_full_unstemmed Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS
title_short Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS
title_sort levodopa–carbidopa intestinal gel in advanced parkinson’s disease: long-term results from cosmos
topic Original Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10130122/
https://www.ncbi.nlm.nih.gov/pubmed/36802031
http://dx.doi.org/10.1007/s00415-023-11615-3
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