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European journal of neurology · 2024

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

СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Santos-García Diego, López-Manzanares Lydia, Muro Inés, Lorenzo-Barreto Pablo, Casas Peña Elena, García-Ramos Rocío, Fernández Valle Tamara, Morata-Martínez Carlos, Baviera-Muñoz Raquel, Martínez-Torres Irene, Álvarez-Sauco María, Alonso-Modino Déborah, Legarda Inés, Valero-García María Fuensanta, Suárez-Muñoz José Andrés, Martínez-Castrillo Juan Carlos, Perona Ana Belén, Salom Jose María, Cubo Esther, Valero-Merino Caridad, López-Ariztegui Nuria, Sánchez Alonso Pilar, Novo Ponte Sabela, Gamo González Elisa, Martín García Raquel, Espinosa Raúl, Carmona Mar, Feliz Cici Esmerali, García Ruíz Pedro, Muñoz Ruíz Teresa, Fernández Rodríguez Beatriz, Mata Marina

Аннотация

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.

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