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

Autor: Santos-García D; Department of Neurology, Hospital Universitario de A Coruña, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.; Grupo de Investigación en Enfermedad de Parkinson y otros Trastornos del Movimiento, Instituto de Investigación Biomédica de A Coruña, A Coruña, Spain.; Hospital San Rafael, A Coruña Fundación Degen, A Coruña, Spain.; Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain., López-Manzanares L; Hospital Universitario la Princesa, Madrid, Spain., Muro I; Hospital Universitario la Princesa, Madrid, Spain., Lorenzo-Barreto P; Hospital Universitario la Princesa, Madrid, Spain., Casas Peña E; Hospital Universitario la Princesa, Madrid, Spain., García-Ramos R; Hospital Clínico Universitario San Carlos, Madrid, Spain., Fernández Valle T; Hospital de Cruces, Bilbao, Spain., Morata-Martínez C; Hospital Universitario la Fe, Valencia, Spain., Baviera-Muñoz R; Hospital Universitario la Fe, Valencia, Spain., Martínez-Torres I; Hospital Universitario la Fe, Valencia, Spain., Álvarez-Sauco M; Hospital General Universitario de Elche, Elche, Ethiopia., Alonso-Modino D; Hospital Universitario de la Candelaria, Santa Cruz de Tenerife, Spain., Legarda I; Hospital Universitario Son Espases, Palma de Mallorca, Spain., Valero-García MF; Hospital Dr. Negrín, Las Palmas de Gran Canaria, Spain., Suárez-Muñoz JA; Hospital Dr. Negrín, Las Palmas de Gran Canaria, Spain., Martínez-Castrillo JC; Hospital Universitario Ramón y Cajal, Madrid, Spain., Perona AB; Complejo Hospitalario Universitario de Albacete, Albacete, Spain., Salom JM; Hospital Clínico Universitario de Valencia, Valencia, Spain., Cubo E; Hospital Universitario de Burgos, Burgos, Spain., Valero-Merino C; Hospital Arnau de Vilanova, Valencia, Spain., López-Ariztegui N; Hospital Universitario de Toledo, Toledo, Spain., Sánchez Alonso P; Hospital Puerta de Hierro, Madrid, Spain., Novo Ponte S; Hospital Puerta de Hierro, Madrid, Spain., Gamo González E; Hospital Puerta de Hierro, Madrid, Spain., Martín García R; Hospital Puerta de Hierro, Madrid, Spain., Espinosa R; Hospital Universitario de Jerez, Cádiz, Spain., Carmona M; Hospital Universitario de Basurto, Bilbao, Spain., Feliz CE; Hospital Fundación Jiménez Díaz, Madrid, Spain., García Ruíz P; Hospital Fundación Jiménez Díaz, Madrid, Spain., Muñoz Ruíz T; Hospital Regional Universitario de Málaga, Malaga, Spain., Fernández Rodríguez B; Hospital Regional Universitario de Málaga, Malaga, Spain., Mata M; Hospital Infanta Sofía, Madrid, Spain.
Jazyk: angličtina
Zdroj: European journal of neurology [Eur J Neurol] 2025 Jan; Vol. 32 (1), pp. e16535. Date of Electronic Publication: 2024 Oct 28.
DOI: 10.1111/ene.16535
Abstrakt: 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.
(© 2024 The Author(s). European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.)
Databáze: MEDLINE
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