PMID- 31668287 OWN - NLM STAT- MEDLINE DCOM- 20210104 LR - 20210104 IS - 0035-3787 (Print) IS - 0035-3787 (Linking) VI - 176 IP - 4 DP - 2020 May TI - Safety and effectiveness of levodopa-carbidopa intestinal gel for advanced Parkinson's disease: A large single-center study. PG - 268-276 LID - S0035-3787(19)30655-1 [pii] LID - 10.1016/j.neurol.2019.07.024 [doi] AB - BACKGROUND: Treatment with levodopa-carbidopa intestinal gel (LCIG) can effectively relieve motor and non-motor symptoms in advanced Parkinson's disease (PD). However, adverse events (AEs) are frequent. OBJECTIVE: To describe AEs associated with LCIG treatment and the main reasons for treatment discontinuation. We also looked for factors that were potentially predictive of serious AEs and assessed the effectiveness of and satisfaction with LCIG. METHOD: We retrospectively analyzed data on AEs in patients treated with LCIG at a French university medical center. For patients still receiving treatment at last follow-up, effectiveness was assessed according to the Clinical Global Impression (CGI) scale and the Movement Disorders Society - Unified Parkinson's Disease Rating Scale motor score. RESULTS: Of the 63 patients treated with LCIG for a mean (range) of 19 months (8-47), 57 (90%) experienced at least one AE (340 AEs in total). Most of the AEs (in 69.8% of the patients) were related to percutaneous endoscopic gastrostomy with a jejunal tube (PEG-J) or affected the gastrointestinal tract (granuloma, leakage, or a local infection). Device-related AEs (such as PEG-J removal and device occlusion) were frequent (in 63.5% of patients). Forty-three patients (68%) required at least one additional endoscopic procedure. Dopatherapy-related AEs occurred in 30 patients (48%). Most of the AEs occurred long after treatment initiations, and only a small proportion led to discontinuation. On the CGI scale, 53 patients (84.4%) considered that their condition had improved during LCIG treatment. CONCLUSION: Despite the high frequency of AEs, patients with advanced PD gain clinical benefit from treatment with LCIG. This treatment requires a competent, multidisciplinary team on site. CI - Copyright (c) 2019 Elsevier Masson SAS. All rights reserved. FAU - Blaise, A-S AU - Blaise AS AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France. Electronic address: annesophie.blaise@outlook.fr. FAU - Baille, G AU - Baille G AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. FAU - Carriere, N AU - Carriere N AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. FAU - Devos, D AU - Devos D AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France; Pharmacology Department, Lille University, 59000 Lille, France. FAU - Dujardin, K AU - Dujardin K AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. FAU - Grolez, G AU - Grolez G AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. FAU - Kreisler, A AU - Kreisler A AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. FAU - Kyheng, M AU - Kyheng M AD - Department of Biostatistics, University & EA 2694, Lille University, 59000 Lille, France. FAU - Moreau, C AU - Moreau C AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. FAU - Mutez, E AU - Mutez E AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. FAU - Seguy, D AU - Seguy D AD - Nutrition department, Lille University, 59000 Lille, France. FAU - Defebvre, L AU - Defebvre L AD - Neurology and Movement Disorders Department, Lille University, 59000 Lille, France; U1171, INSERM, Lille University, 59000 Lille, France. LA - eng PT - Journal Article DEP - 20191023 PL - France TA - Rev Neurol (Paris) JT - Revue neurologique JID - 2984779R RN - 0 (Antiparkinson Agents) RN - 0 (Drug Combinations) RN - 0 (Gels) RN - 0 (carbidopa, levodopa drug combination) RN - 46627O600J (Levodopa) RN - MNX7R8C5VO (Carbidopa) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antiparkinson Agents/administration & dosage/adverse effects/pharmacokinetics MH - Carbidopa/*administration & dosage/*adverse effects/pharmacokinetics MH - Catheters, Indwelling/adverse effects MH - Drug Combinations MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology MH - Endoscopy, Gastrointestinal/adverse effects/instrumentation MH - Female MH - France/epidemiology MH - Gastrostomy/adverse effects MH - Gels MH - Humans MH - Infusion Pumps/adverse effects MH - Intestinal Absorption MH - Levodopa/*administration & dosage/*adverse effects/pharmacokinetics MH - Male MH - Mental Status and Dementia Tests MH - Middle Aged MH - Parkinson Disease/*drug therapy/epidemiology/metabolism/pathology MH - Retrospective Studies MH - Severity of Illness Index MH - Treatment Outcome OTO - NOTNLM OT - Adverse event OT - Gastrostomy OT - Levodopa-carbidopa intestinal gel OT - Parkinson's disease EDAT- 2019/11/02 06:00 MHDA- 2021/01/05 06:00 CRDT- 2019/11/01 06:00 PHST- 2019/05/13 00:00 [received] PHST- 2019/07/21 00:00 [revised] PHST- 2019/07/23 00:00 [accepted] PHST- 2019/11/02 06:00 [pubmed] PHST- 2021/01/05 06:00 [medline] PHST- 2019/11/01 06:00 [entrez] AID - S0035-3787(19)30655-1 [pii] AID - 10.1016/j.neurol.2019.07.024 [doi] PST - ppublish SO - Rev Neurol (Paris). 2020 May;176(4):268-276. doi: 10.1016/j.neurol.2019.07.024. Epub 2019 Oct 23.