Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease

Abstract 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...

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Autores principales:	Francesc Valldeoriola, María José Catalán, Francisco Escamilla-Sevilla, Eric Freire, Jesús Olivares, Esther Cubo, Diego Santos García, Matilde Calopa, Pablo Martínez-Martín, Juan Carlos Parra, Gloria Arroyo, José Matías Arbelo
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/b29e73979abe4d5b826cdca39dd2e61d
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spelling	oai:doaj.org-article:b29e73979abe4d5b826cdca39dd2e61d2021-12-05T12:17:24ZPatient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease10.1038/s41531-021-00246-y2373-8057https://doaj.org/article/b29e73979abe4d5b826cdca39dd2e61d2021-11-01T00:00:00Zhttps://doi.org/10.1038/s41531-021-00246-yhttps://doaj.org/toc/2373-8057Abstract 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.Francesc ValldeoriolaMaría José CatalánFrancisco Escamilla-SevillaEric FreireJesús OlivaresEsther CuboDiego Santos GarcíaMatilde CalopaPablo Martínez-MartínJuan Carlos ParraGloria ArroyoJosé Matías ArbeloNature PortfolioarticleNeurology. Diseases of the nervous systemRC346-429ENnpj Parkinson's Disease, Vol 7, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurology. Diseases of the nervous system RC346-429 Francesc Valldeoriola María José Catalán Francisco Escamilla-Sevilla Eric Freire Jesús Olivares Esther Cubo Diego Santos García Matilde Calopa Pablo Martínez-Martín Juan Carlos Parra Gloria Arroyo José Matías Arbelo Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease
description	Abstract 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	article
author	Francesc Valldeoriola María José Catalán Francisco Escamilla-Sevilla Eric Freire Jesús Olivares Esther Cubo Diego Santos García Matilde Calopa Pablo Martínez-Martín Juan Carlos Parra Gloria Arroyo José Matías Arbelo
author_facet	Francesc Valldeoriola María José Catalán Francisco Escamilla-Sevilla Eric Freire Jesús Olivares Esther Cubo Diego Santos García Matilde Calopa Pablo Martínez-Martín Juan Carlos Parra Gloria Arroyo José Matías Arbelo
author_sort	Francesc Valldeoriola
title	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_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_sort	patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced parkinson’s disease
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/b29e73979abe4d5b826cdca39dd2e61d
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Patient and caregiver outcomes with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease

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