Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study

Background and purpose: Levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion is a recently developed device-aided therapy for advanced Parkinson disease (PD) patients. The aim of this study was to report real-world evidence about the effectiveness, tolerability, and safety of LECIG in PD pa...

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Autores: Santos-García, D, López-Manzanares, L, Muro, I, Lorenzo-Barreto, P, Peña, EC, García-Ramos, R, Valle, TF, Morata-Martínez, C, Baviera-Muñoz, R, Martínez-Torres, I, Alvarez-Sauco, M, Alonso-Modino, D, Legarda, I, Valero-García, MF, Suárez-Muñoz, JA, Martínez-Castrillo, JC, Perona, AB, Salom, JM, Cubo, E, Valero-Merino, C, López-Ariztegui, N, Alonso, PS, Ponte, SN, González, EG, García, RM, Espinosa, R, Carmona, M, Feliz, CE, Ruíz, PG, Ruíz, TM, Rodríguez, BF, Mata, M
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p18048
Acceso en línea:https://fisabio.portalinvestigacion.com/publicaciones/18048
Access Level:acceso abierto
Palabra clave:effectiveness
infusion
levodopa-entacapone-carbidopa
Parkinson disease
safety
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spelling Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data studySantos-García, DLópez-Manzanares, LMuro, ILorenzo-Barreto, PPeña, ECGarcía-Ramos, RValle, TFMorata-Martínez, CBaviera-Muñoz, RMartínez-Torres, IAlvarez-Sauco, MAlonso-Modino, DLegarda, IValero-García, MFSuárez-Muñoz, JAMartínez-Castrillo, JCPerona, ABSalom, JMCubo, EValero-Merino, CLópez-Ariztegui, NAlonso, PSPonte, SNGonzález, EGGarcía, RMEspinosa, RCarmona, MFeliz, CERuíz, PGRuíz, TMRodríguez, BFMata, Meffectivenessinfusionlevodopa-entacapone-carbidopaParkinson diseasesafetyBackground and purpose: Levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion is a recently developed device-aided therapy for advanced Parkinson disease (PD) patients. The aim of this study was to report real-world evidence about the effectiveness, tolerability, and safety of LECIG in PD patients. Methods: A multicenter observational retrospective study of the first patients who initiated LECIG in Spain was performed. All neurologists with an experience of at least two patients treated until 30 March 2024 were invited to participate. Data about effectiveness and safety from the medical records (V0, pre-LECIG; V1, initiation of LECIG; V2, post-LECIG follow-up) with a total of 246 variables were collected. Results: Seventy-three PD patients (61.6% males, 70.1 +/- 9.1 years old) from 21 Spanish centers with a mean disease duration of 14.4 +/- 6.3 years (range = 5-31) were included. Twenty-six patients (35.6%) were switched directly from levodopa-carbidopa intestinal gel. The mean exposure to LECIG was 177.3 +/- 110.5 days (range = 7-476). The mean daily OFF time decreased from 5.2 +/- 3 (pre-LECIG) to 1.9 +/- 1.8 (post-LECIG; n = 66, p < 0.0001). Global improvement was observed in >85% of the patients. No significant change was detected in the levodopa equivalent daily dose from V0 to V2. Only 7% received 24-h infusion, and 24.7% required more than one cartridge per day at V2. Thirty-four patients (46.6%) had at least one adverse event related to LECIG and/or the device system. Five patients (6.8%) discontinued LECIG. Conclusions: LECIG was safe and effective in advanced PD patients.Blackwell Publishing Inc.2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fisabio.portalinvestigacion.com/publicaciones/18048EUROPEAN JOURNAL OF NEUROLOGYISSN: 14681331ISSNe: 13515101reponame:r-FISABIO. Repositorio Institucional de Producción Científicainstname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)Inglésinfo:eu-repo/semantics/openAccessoai:fisabio.fundanetsuite.com:p180482026-06-11T12:45:17Z
dc.title.none.fl_str_mv Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
title Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
spellingShingle Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
Santos-García, D
effectiveness
infusion
levodopa-entacapone-carbidopa
Parkinson disease
safety
title_short Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
title_full Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
title_fullStr Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
title_full_unstemmed Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
title_sort Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study
dc.creator.none.fl_str_mv Santos-García, D
López-Manzanares, L
Muro, I
Lorenzo-Barreto, P
Peña, EC
García-Ramos, R
Valle, TF
Morata-Martínez, C
Baviera-Muñoz, R
Martínez-Torres, I
Alvarez-Sauco, M
Alonso-Modino, D
Legarda, I
Valero-García, MF
Suárez-Muñoz, JA
Martínez-Castrillo, JC
Perona, AB
Salom, JM
Cubo, E
Valero-Merino, C
López-Ariztegui, N
Alonso, PS
Ponte, SN
González, EG
García, RM
Espinosa, R
Carmona, M
Feliz, CE
Ruíz, PG
Ruíz, TM
Rodríguez, BF
Mata, M
author Santos-García, D
author_facet Santos-García, D
López-Manzanares, L
Muro, I
Lorenzo-Barreto, P
Peña, EC
García-Ramos, R
Valle, TF
Morata-Martínez, C
Baviera-Muñoz, R
Martínez-Torres, I
Alvarez-Sauco, M
Alonso-Modino, D
Legarda, I
Valero-García, MF
Suárez-Muñoz, JA
Martínez-Castrillo, JC
Perona, AB
Salom, JM
Cubo, E
Valero-Merino, C
López-Ariztegui, N
Alonso, PS
Ponte, SN
González, EG
García, RM
Espinosa, R
Carmona, M
Feliz, CE
Ruíz, PG
Ruíz, TM
Rodríguez, BF
Mata, M
author_role author
author2 López-Manzanares, L
Muro, I
Lorenzo-Barreto, P
Peña, EC
García-Ramos, R
Valle, TF
Morata-Martínez, C
Baviera-Muñoz, R
Martínez-Torres, I
Alvarez-Sauco, M
Alonso-Modino, D
Legarda, I
Valero-García, MF
Suárez-Muñoz, JA
Martínez-Castrillo, JC
Perona, AB
Salom, JM
Cubo, E
Valero-Merino, C
López-Ariztegui, N
Alonso, PS
Ponte, SN
González, EG
García, RM
Espinosa, R
Carmona, M
Feliz, CE
Ruíz, PG
Ruíz, TM
Rodríguez, BF
Mata, M
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv effectiveness
infusion
levodopa-entacapone-carbidopa
Parkinson disease
safety
topic effectiveness
infusion
levodopa-entacapone-carbidopa
Parkinson disease
safety
description Background and purpose: Levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion is a recently developed device-aided therapy for advanced Parkinson disease (PD) patients. The aim of this study was to report real-world evidence about the effectiveness, tolerability, and safety of LECIG in PD patients. Methods: A multicenter observational retrospective study of the first patients who initiated LECIG in Spain was performed. All neurologists with an experience of at least two patients treated until 30 March 2024 were invited to participate. Data about effectiveness and safety from the medical records (V0, pre-LECIG; V1, initiation of LECIG; V2, post-LECIG follow-up) with a total of 246 variables were collected. Results: Seventy-three PD patients (61.6% males, 70.1 +/- 9.1 years old) from 21 Spanish centers with a mean disease duration of 14.4 +/- 6.3 years (range = 5-31) were included. Twenty-six patients (35.6%) were switched directly from levodopa-carbidopa intestinal gel. The mean exposure to LECIG was 177.3 +/- 110.5 days (range = 7-476). The mean daily OFF time decreased from 5.2 +/- 3 (pre-LECIG) to 1.9 +/- 1.8 (post-LECIG; n = 66, p < 0.0001). Global improvement was observed in >85% of the patients. No significant change was detected in the levodopa equivalent daily dose from V0 to V2. Only 7% received 24-h infusion, and 24.7% required more than one cartridge per day at V2. Thirty-four patients (46.6%) had at least one adverse event related to LECIG and/or the device system. Five patients (6.8%) discontinued LECIG. Conclusions: LECIG was safe and effective in advanced PD patients.
publishDate 2024
dc.date.none.fl_str_mv 2024
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://fisabio.portalinvestigacion.com/publicaciones/18048
url https://fisabio.portalinvestigacion.com/publicaciones/18048
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 Blackwell Publishing Inc.
publisher.none.fl_str_mv Blackwell Publishing Inc.
dc.source.none.fl_str_mv EUROPEAN JOURNAL OF NEUROLOGY
ISSN: 14681331
ISSNe: 13515101
reponame:r-FISABIO. Repositorio Institucional de Producción Científica
instname:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
instname_str Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
reponame_str r-FISABIO. Repositorio Institucional de Producción Científica
collection r-FISABIO. Repositorio Institucional de Producción Científica
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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