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Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results
BACKGROUND: Levodopa-carbidopa intestinal gel (LCIG) improves motor and non-motor symptoms in patients with advanced Parkinson’s disease (aPD). OBJECTIVE: To present the final 36-month efficacy and safety results from DUOGLOBE (DUOdopa/Duopa in Patients with Advanced Parkinson’s Disease – a GLobal O...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
IOS Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10473130/ https://www.ncbi.nlm.nih.gov/pubmed/37302039 http://dx.doi.org/10.3233/JPD-225105 |
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author | Chaudhuri, K. Ray Kovács, Norbert Pontieri, Francesco E. Aldred, Jason Bourgeois, Paul Davis, Thomas L. Cubo, Esther Anca-Herschkovitsch, Marieta Iansek, Robert Siddiqui, Mustafa S. Simu, Mihaela Bergmann, Lars Ballina, Mayra Kukreja, Pavnit Ladhani, Omar Jia, Jia Standaert, David G. |
author_facet | Chaudhuri, K. Ray Kovács, Norbert Pontieri, Francesco E. Aldred, Jason Bourgeois, Paul Davis, Thomas L. Cubo, Esther Anca-Herschkovitsch, Marieta Iansek, Robert Siddiqui, Mustafa S. Simu, Mihaela Bergmann, Lars Ballina, Mayra Kukreja, Pavnit Ladhani, Omar Jia, Jia Standaert, David G. |
author_sort | Chaudhuri, K. Ray |
collection | PubMed |
description | BACKGROUND: Levodopa-carbidopa intestinal gel (LCIG) improves motor and non-motor symptoms in patients with advanced Parkinson’s disease (aPD). OBJECTIVE: To present the final 36-month efficacy and safety results from DUOGLOBE (DUOdopa/Duopa in Patients with Advanced Parkinson’s Disease – a GLobal OBservational Study Evaluating Long-Term Effectiveness; NCT02611713). METHODS: DUOGLOBE was an international, prospective, long-term, real-world, observational study of patients with aPD initiating LCIG in routine clinical care. The primary endpoint was change in patient-reported “Off” time to Month 36. Safety was assessed by monitoring serious adverse events (SAEs). RESULTS: Significant improvements in “Off” time were maintained over 3 years (mean [SD]: –3.3 hours [3.7]; p < 0.001). There were significant improvements to Month 36 in total scores of the Unified Dyskinesia Rating Scale (–5.9 [23.7]; p = 0.044), Non-Motor Symptoms Scale (–14.3 [40.5]; p = 0.002), Parkinson’s Disease Sleep Scale-2 (–5.8 [12.9]; p < 0.001), and Epworth Sleepiness Scale (–1.8 [6.0]; p = 0.008). Health-related quality of life and caregiver burden significantly improved through Months 24 and 30, respectively (Month 24, 8-item Parkinson’s Disease Questionnaire Summary Index, –6.0 [22.5]; p = 0.006; Month 30, Modified Caregiver Strain Index, –2.3 [7.6]; p = 0.026). Safety was consistent with the well-established LCIG profile (SAEs: 54.9% of patients; discontinuations: 54.4%; discontinuations due to an adverse event: 27.2%). Of 106 study discontinuations, 32 patients (30.2%) continued LCIG outside the study. CONCLUSION: DUOGLOBE demonstrates real-world, long-term, reductions in motor and non-motor symptoms in patients with aPD treated with LCIG. |
format | Online Article Text |
id | pubmed-10473130 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | IOS Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-104731302023-09-02 Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results Chaudhuri, K. Ray Kovács, Norbert Pontieri, Francesco E. Aldred, Jason Bourgeois, Paul Davis, Thomas L. Cubo, Esther Anca-Herschkovitsch, Marieta Iansek, Robert Siddiqui, Mustafa S. Simu, Mihaela Bergmann, Lars Ballina, Mayra Kukreja, Pavnit Ladhani, Omar Jia, Jia Standaert, David G. J Parkinsons Dis Research Report BACKGROUND: Levodopa-carbidopa intestinal gel (LCIG) improves motor and non-motor symptoms in patients with advanced Parkinson’s disease (aPD). OBJECTIVE: To present the final 36-month efficacy and safety results from DUOGLOBE (DUOdopa/Duopa in Patients with Advanced Parkinson’s Disease – a GLobal OBservational Study Evaluating Long-Term Effectiveness; NCT02611713). METHODS: DUOGLOBE was an international, prospective, long-term, real-world, observational study of patients with aPD initiating LCIG in routine clinical care. The primary endpoint was change in patient-reported “Off” time to Month 36. Safety was assessed by monitoring serious adverse events (SAEs). RESULTS: Significant improvements in “Off” time were maintained over 3 years (mean [SD]: –3.3 hours [3.7]; p < 0.001). There were significant improvements to Month 36 in total scores of the Unified Dyskinesia Rating Scale (–5.9 [23.7]; p = 0.044), Non-Motor Symptoms Scale (–14.3 [40.5]; p = 0.002), Parkinson’s Disease Sleep Scale-2 (–5.8 [12.9]; p < 0.001), and Epworth Sleepiness Scale (–1.8 [6.0]; p = 0.008). Health-related quality of life and caregiver burden significantly improved through Months 24 and 30, respectively (Month 24, 8-item Parkinson’s Disease Questionnaire Summary Index, –6.0 [22.5]; p = 0.006; Month 30, Modified Caregiver Strain Index, –2.3 [7.6]; p = 0.026). Safety was consistent with the well-established LCIG profile (SAEs: 54.9% of patients; discontinuations: 54.4%; discontinuations due to an adverse event: 27.2%). Of 106 study discontinuations, 32 patients (30.2%) continued LCIG outside the study. CONCLUSION: DUOGLOBE demonstrates real-world, long-term, reductions in motor and non-motor symptoms in patients with aPD treated with LCIG. IOS Press 2023-07-25 /pmc/articles/PMC10473130/ /pubmed/37302039 http://dx.doi.org/10.3233/JPD-225105 Text en © 2023 – The authors. Published by IOS Press https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) License (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Research Report Chaudhuri, K. Ray Kovács, Norbert Pontieri, Francesco E. Aldred, Jason Bourgeois, Paul Davis, Thomas L. Cubo, Esther Anca-Herschkovitsch, Marieta Iansek, Robert Siddiqui, Mustafa S. Simu, Mihaela Bergmann, Lars Ballina, Mayra Kukreja, Pavnit Ladhani, Omar Jia, Jia Standaert, David G. Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results |
title | Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results |
title_full | Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results |
title_fullStr | Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results |
title_full_unstemmed | Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results |
title_short | Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results |
title_sort | levodopa carbidopa intestinal gel in advanced parkinson’s disease: duoglobe final 3-year results |
topic | Research Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10473130/ https://www.ncbi.nlm.nih.gov/pubmed/37302039 http://dx.doi.org/10.3233/JPD-225105 |
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