Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry

Introduction: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. Methods: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were e...

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Autores: Antonini, A, Poewe, W, Chaudhuri, KR, Jech, R, Pickut, B, Pirtosek, Z, Szasz, J, Valldeoriola, F, Winkler, C, Bergmann, L, Yegin, A, Onuk, K, Barch, D, Odin, P, Kulisevsky J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2017
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p6206
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=6206
Access Level:acceso abierto
Palabra clave:Parkinson's disease
Levodopa-carbidopa intestinal gel
Motor symptoms
Non-motor symptoms
Routine patient care
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spelling Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registryAntonini, APoewe, WChaudhuri, KRJech, RPickut, BPirtosek, ZSzasz, JValldeoriola, FWinkler, CBergmann, LYegin, AOnuk, KBarch, DOdin, PKulisevsky J.Parkinson's diseaseLevodopa-carbidopa intestinal gelMotor symptomsNon-motor symptomsRoutine patient careIntroduction: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. Methods: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naive patients (60% of patients) and partially retrospective for patients with <= 12 months of pre-treatment with LCIG (40% of patients). Hours of "On" and "Off" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. Results: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in "Off" time (hours/day) (mean +/- SD = -4.1 +/- 3.5, P < 0.001), "On" time with dyskinesia (hours/day) (-1.1 +/- 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 +/- 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 +/- 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). Conclusions: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG. (C) 2017 The Authors. Published by Elsevier Ltd.ELSEVIER SCI LTD2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=6206PARKINSONISM & RELATED DISORDERSISSN: 13538020ISSNe: 18735126reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p62062026-06-14T12:41:47Z
dc.title.none.fl_str_mv Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
title Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
spellingShingle Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
Antonini, A
Parkinson's disease
Levodopa-carbidopa intestinal gel
Motor symptoms
Non-motor symptoms
Routine patient care
title_short Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
title_full Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
title_fullStr Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
title_full_unstemmed Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
title_sort Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
dc.creator.none.fl_str_mv Antonini, A
Poewe, W
Chaudhuri, KR
Jech, R
Pickut, B
Pirtosek, Z
Szasz, J
Valldeoriola, F
Winkler, C
Bergmann, L
Yegin, A
Onuk, K
Barch, D
Odin, P
Kulisevsky J.
author Antonini, A
author_facet Antonini, A
Poewe, W
Chaudhuri, KR
Jech, R
Pickut, B
Pirtosek, Z
Szasz, J
Valldeoriola, F
Winkler, C
Bergmann, L
Yegin, A
Onuk, K
Barch, D
Odin, P
Kulisevsky J.
author_role author
author2 Poewe, W
Chaudhuri, KR
Jech, R
Pickut, B
Pirtosek, Z
Szasz, J
Valldeoriola, F
Winkler, C
Bergmann, L
Yegin, A
Onuk, K
Barch, D
Odin, P
Kulisevsky J.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Parkinson's disease
Levodopa-carbidopa intestinal gel
Motor symptoms
Non-motor symptoms
Routine patient care
topic Parkinson's disease
Levodopa-carbidopa intestinal gel
Motor symptoms
Non-motor symptoms
Routine patient care
description Introduction: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. Methods: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naive patients (60% of patients) and partially retrospective for patients with <= 12 months of pre-treatment with LCIG (40% of patients). Hours of "On" and "Off" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. Results: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in "Off" time (hours/day) (mean +/- SD = -4.1 +/- 3.5, P < 0.001), "On" time with dyskinesia (hours/day) (-1.1 +/- 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 +/- 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 +/- 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). Conclusions: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG. (C) 2017 The Authors. Published by Elsevier Ltd.
publishDate 2017
dc.date.none.fl_str_mv 2017
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=6206
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=6206
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER SCI LTD
publisher.none.fl_str_mv ELSEVIER SCI LTD
dc.source.none.fl_str_mv PARKINSONISM & RELATED DISORDERS
ISSN: 13538020
ISSNe: 18735126
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
repository.name.fl_str_mv
repository.mail.fl_str_mv
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