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Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease
Levodopa-carbidopa intestinal gel (LCIG) has shown to be efficacious in motor and non-motor symptoms (NMS). Nevertheless, studies with patient Quality of Life (QoL) as a primary endpoint are scarce. To assess the effect of LCIG on Advanced Parkinson’s Disease (APD) patients QoL. Secondarily, the imp...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8633325/ https://www.ncbi.nlm.nih.gov/pubmed/34848716 http://dx.doi.org/10.1038/s41531-021-00246-y |
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author | Valldeoriola, Francesc Catalán, María José Escamilla-Sevilla, Francisco Freire, Eric Olivares, Jesús Cubo, Esther García, Diego Santos Calopa, Matilde Martínez-Martín, Pablo Parra, Juan Carlos Arroyo, Gloria Arbelo, José Matías |
author_facet | Valldeoriola, Francesc Catalán, María José Escamilla-Sevilla, Francisco Freire, Eric Olivares, Jesús Cubo, Esther García, Diego Santos Calopa, Matilde Martínez-Martín, Pablo Parra, Juan Carlos Arroyo, Gloria Arbelo, José Matías |
author_sort | Valldeoriola, Francesc |
collection | PubMed |
description | Levodopa-carbidopa intestinal gel (LCIG) has shown to be efficacious in motor and non-motor symptoms (NMS). Nevertheless, studies with patient Quality of Life (QoL) as a primary endpoint are scarce. To assess the effect of LCIG on Advanced Parkinson’s Disease (APD) patients QoL. Secondarily, the impact on motor symptoms and NMS, emotional well-being, treatment satisfaction, and caregiver QoL, stress, disease burden, anxiety, depression, and work impairment were also investigated. In this prospective, 6-month multicenter postmarketing observational study, LCIG was administered to 59 patients with APD. Endpoints were assessed using validated scales and questionnaires. LCIG significantly improved patient QoL (PDQ-39 mean change ± standard deviation from baseline, −12.8 ± 14.6; P < 0.0001), motor symptoms (UPDRS-III in “On,” −6.5 ± 11.8; P = 0.0002), NMS (NMSS, −35.7 ± 31.1; P < 0.0001), mood (Norris/Bond-Lader VAS, −6.6 ± 21.1; P = 0.0297), fatigue (PFS-16, −0.6 ± 1.0; P = 0.0003), depression (BDI-II, −5.1 ± 9.4; P = 0.0002), anxiety (BAI, −6.2 ± 9.6; P < 0.0001), and patient treatment satisfaction (SATMED-Q, 16.1 ± 16.8; P < 0.0001). There were significant correlations between the change from baseline to 6 months between PDQ-39 and UPDRS-IV, NMSS, BAI, BDI-II, AS, and PFS-16 scores, and Norris/Bond-Lader alertness/sedation factor. Caregiver anxiety also improved (Goldberg anxiety scale, −1.1 ± 1.0; P = 0.0234), but the clinical relevance of this finding is questionable. The serious adverse events reported were similar to those previously described for LCIG. In patients with APD, LCIG improves QoL, motor symptoms and NMS, emotional well-being, and satisfaction with the treatment. Improvement in patient QoL is associated with improvements in motor complications, NMS, anxiety, depression, apathy and fatigue. Improvements in patients’ QoL does not correspond with improvements in caregivers’ QoL or burden. |
format | Online Article Text |
id | pubmed-8633325 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-86333252021-12-15 Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease Valldeoriola, Francesc Catalán, María José Escamilla-Sevilla, Francisco Freire, Eric Olivares, Jesús Cubo, Esther García, Diego Santos Calopa, Matilde Martínez-Martín, Pablo Parra, Juan Carlos Arroyo, Gloria Arbelo, José Matías NPJ Parkinsons Dis Article Levodopa-carbidopa intestinal gel (LCIG) has shown to be efficacious in motor and non-motor symptoms (NMS). Nevertheless, studies with patient Quality of Life (QoL) as a primary endpoint are scarce. To assess the effect of LCIG on Advanced Parkinson’s Disease (APD) patients QoL. Secondarily, the impact on motor symptoms and NMS, emotional well-being, treatment satisfaction, and caregiver QoL, stress, disease burden, anxiety, depression, and work impairment were also investigated. In this prospective, 6-month multicenter postmarketing observational study, LCIG was administered to 59 patients with APD. Endpoints were assessed using validated scales and questionnaires. LCIG significantly improved patient QoL (PDQ-39 mean change ± standard deviation from baseline, −12.8 ± 14.6; P < 0.0001), motor symptoms (UPDRS-III in “On,” −6.5 ± 11.8; P = 0.0002), NMS (NMSS, −35.7 ± 31.1; P < 0.0001), mood (Norris/Bond-Lader VAS, −6.6 ± 21.1; P = 0.0297), fatigue (PFS-16, −0.6 ± 1.0; P = 0.0003), depression (BDI-II, −5.1 ± 9.4; P = 0.0002), anxiety (BAI, −6.2 ± 9.6; P < 0.0001), and patient treatment satisfaction (SATMED-Q, 16.1 ± 16.8; P < 0.0001). There were significant correlations between the change from baseline to 6 months between PDQ-39 and UPDRS-IV, NMSS, BAI, BDI-II, AS, and PFS-16 scores, and Norris/Bond-Lader alertness/sedation factor. Caregiver anxiety also improved (Goldberg anxiety scale, −1.1 ± 1.0; P = 0.0234), but the clinical relevance of this finding is questionable. The serious adverse events reported were similar to those previously described for LCIG. In patients with APD, LCIG improves QoL, motor symptoms and NMS, emotional well-being, and satisfaction with the treatment. Improvement in patient QoL is associated with improvements in motor complications, NMS, anxiety, depression, apathy and fatigue. Improvements in patients’ QoL does not correspond with improvements in caregivers’ QoL or burden. Nature Publishing Group UK 2021-11-30 /pmc/articles/PMC8633325/ /pubmed/34848716 http://dx.doi.org/10.1038/s41531-021-00246-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This 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 license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license 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 license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Valldeoriola, Francesc Catalán, María José Escamilla-Sevilla, Francisco Freire, Eric Olivares, Jesús Cubo, Esther García, Diego Santos Calopa, Matilde Martínez-Martín, Pablo Parra, Juan Carlos Arroyo, Gloria Arbelo, José Matías Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease |
title | Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease |
title_full | Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease |
title_fullStr | Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease |
title_full_unstemmed | Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease |
title_short | Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease |
title_sort | patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced parkinson’s disease |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8633325/ https://www.ncbi.nlm.nih.gov/pubmed/34848716 http://dx.doi.org/10.1038/s41531-021-00246-y |
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