Levodopa-carbidopa intestinal gel in ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
Levodopa-carbidopa intestinal gel in advanced parkinson's: final results of the gloria registry
Author(s) :
Antonini, Angelo [Auteur]
Poewe, Werner [Auteur]
Chaudhuri, K. Ray [Auteur]
Jech, Robert [Auteur]
Pickut, Barbara [Auteur]
Pirtosek, Zvezdan [Auteur]
Szasz, Jozsef [Auteur]
Valldeoriola, Francesc [Auteur]
Winkler, Christian [Auteur]
Bergmann, Lars [Auteur]
Yegin, Ashley [Auteur]
Onuk, Koray [Auteur]
Barch, David [Auteur]
Odin, Per [Auteur]
Poewe, Werner [Auteur]
Chaudhuri, K. Ray [Auteur]
Jech, Robert [Auteur]
Pickut, Barbara [Auteur]
Pirtosek, Zvezdan [Auteur]
Szasz, Jozsef [Auteur]
Valldeoriola, Francesc [Auteur]
Winkler, Christian [Auteur]
Bergmann, Lars [Auteur]
Yegin, Ashley [Auteur]
Onuk, Koray [Auteur]
Barch, David [Auteur]
Odin, Per [Auteur]
Journal title :
Parkinsonism & related disorders
Abbreviated title :
Parkinsonism Relat. Disord.
Volume number :
45
Pages :
13-20
Publication date :
2017-12-01
ISSN :
1873-5126
English keyword(s) :
Parkinson''s disease
Levodopa-carbidopa intestinal gel
Non-motor symptoms
Motor symptoms
Routine patient care
Levodopa-carbidopa intestinal gel
Non-motor symptoms
Motor symptoms
Routine patient care
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
BACKGROUND: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care.
METHODS: Motor fluctuations, ...
Show more >BACKGROUND: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. METHODS: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naïve patients (60% of patients) and partially retrospective for patients with ≤12 months of pre-treatment with LCIG (40% of patients). Hours of "On" and "Off" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. RESULTS: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in "Off" time (hours/day) (mean ± SD = -4.1 ± 3.5, P < 0.001), "On" time with dyskinesia (hours/day) (-1.1 ± 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 ± 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 ± 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). CONCLUSIONS: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG.Show less >
Show more >BACKGROUND: This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. METHODS: Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naïve patients (60% of patients) and partially retrospective for patients with ≤12 months of pre-treatment with LCIG (40% of patients). Hours of "On" and "Off" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. RESULTS: Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in "Off" time (hours/day) (mean ± SD = -4.1 ± 3.5, P < 0.001), "On" time with dyskinesia (hours/day) (-1.1 ± 4.8, P = 0.006), Non-Motor Symptom Scale total (-16.7 ± 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 ± 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). CONCLUSIONS: LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
CNRS
Inserm
Université de Lille
CNRS
Inserm
Université de Lille
Collections :
Research team(s) :
Troubles cognitifs dégénératifs et vasculaires
Submission date :
2019-11-27T14:28:24Z