Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: long-term results from COSMOS.
Dyskinesia
Long-term treatment
Motor symptoms
Nonmotor symptoms
Parkinson's disease
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
May 2023
May 2023
Historique:
received:
31
10
2022
accepted:
07
02
2023
revised:
17
01
2023
medline:
27
4
2023
pubmed:
22
2
2023
entrez:
21
2
2023
Statut:
ppublish
Résumé
While immediate benefits of levodopa-carbidopa intestinal gel (LCIG) are evident in patients with Parkinson's disease (PD), long-term LCIG effects require further study. We explored long-term LCIG on motor symptoms, nonmotor symptoms (NMS), and LCIG treatment settings in patients with advanced PD (APD). Data were obtained (medical records and patient visit) from COSMOS, a multinational, retrospective, cross-sectional post-marketing observational study in patients with APD. Patients were stratified into 5 groups based on LCIG treatment duration at the patient visit, from 1-2 to > 5 years LCIG. Between-group differences were assessed for changes from baseline in LCIG settings, motor symptoms, NMS, add-on medications, and safety. Out of 387 patients, the number of patients per LCIG group was: > 1- ≤ 2 years LCIG (n = 156); > 2- ≤ 3 years LCIG (n = 80); > 3- ≤ 4 years LCIG (n = 61); > 4- ≤ 5 years LCIG (n = 30); > 5 years LCIG (n = 60). Baseline values were similar; data reported are changes from the baseline. There were reductions in "off" time, dyskinesia duration, and severity across LCIG groups. Prevalence, severity, and frequency of many individual motor symptoms and some NMS were reduced amongst all LCIG groups, with few differences between groups. Doses for LCIG, LEDD and LEDD for add-on medications were similar across groups both at LCIG initiation and patient visit. Adverse events were similar across all LCIG groups and consistent with the established safety profile of LCIG. LCIG may provide sustained, long-term symptom control, while potentially avoiding increases in add-on medication dosages. ClinicalTrials.gov Identifier: NCT03362879. Number and date: P16-831, November 30, 2017.
Sections du résumé
BACKGROUND
BACKGROUND
While immediate benefits of levodopa-carbidopa intestinal gel (LCIG) are evident in patients with Parkinson's disease (PD), long-term LCIG effects require further study.
OBJECTIVES
OBJECTIVE
We explored long-term LCIG on motor symptoms, nonmotor symptoms (NMS), and LCIG treatment settings in patients with advanced PD (APD).
METHODS
METHODS
Data were obtained (medical records and patient visit) from COSMOS, a multinational, retrospective, cross-sectional post-marketing observational study in patients with APD. Patients were stratified into 5 groups based on LCIG treatment duration at the patient visit, from 1-2 to > 5 years LCIG. Between-group differences were assessed for changes from baseline in LCIG settings, motor symptoms, NMS, add-on medications, and safety.
RESULTS
RESULTS
Out of 387 patients, the number of patients per LCIG group was: > 1- ≤ 2 years LCIG (n = 156); > 2- ≤ 3 years LCIG (n = 80); > 3- ≤ 4 years LCIG (n = 61); > 4- ≤ 5 years LCIG (n = 30); > 5 years LCIG (n = 60). Baseline values were similar; data reported are changes from the baseline. There were reductions in "off" time, dyskinesia duration, and severity across LCIG groups. Prevalence, severity, and frequency of many individual motor symptoms and some NMS were reduced amongst all LCIG groups, with few differences between groups. Doses for LCIG, LEDD and LEDD for add-on medications were similar across groups both at LCIG initiation and patient visit. Adverse events were similar across all LCIG groups and consistent with the established safety profile of LCIG.
CONCLUSIONS
CONCLUSIONS
LCIG may provide sustained, long-term symptom control, while potentially avoiding increases in add-on medication dosages.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Identifier: NCT03362879. Number and date: P16-831, November 30, 2017.
Identifiants
pubmed: 36802031
doi: 10.1007/s00415-023-11615-3
pii: 10.1007/s00415-023-11615-3
pmc: PMC10130122
doi:
Substances chimiques
Carbidopa
MNX7R8C5VO
Levodopa
46627O600J
Antiparkinson Agents
0
Drug Combinations
0
Gels
0
Banques de données
ClinicalTrials.gov
['NCT03362879']
Types de publication
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2765-2775Informations de copyright
© 2023. The Author(s).
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