Advanced

Levodopa-carbidopa intestinal gel in advanced Parkinson's : Final results of the GLORIA registry

Antonini, Angelo; Poewe, Werner; Chaudhuri, K. Ray; Jech, Robert; Pickut, Barbara; Pirtošek, Zvezdan; Szasz, Jozsef; Valldeoriola, Francesc; Winkler, Christian and Bergmann, Lars, et al. (2017) In Parkinsonism and Related Disorders
Abstract

Introduction: 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... (More)

Introduction: 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.

(Less)
Please use this url to cite or link to this publication:
author
, et al. (More)
(Less)
organization
publishing date
type
Contribution to journal
publication status
in press
subject
keywords
Levodopa-carbidopa intestinal gel, Motor symptoms, Non-motor symptoms, Parkinson's disease, Routine patient care
in
Parkinsonism and Related Disorders
publisher
Elsevier
external identifiers
  • scopus:85031330718
ISSN
1353-8020
DOI
10.1016/j.parkreldis.2017.09.018
language
English
LU publication?
yes
id
0f9378a8-c72f-4a72-85d9-81d2ad4fc32b
date added to LUP
2017-11-07 16:03:42
date last changed
2018-01-07 12:25:16
@article{0f9378a8-c72f-4a72-85d9-81d2ad4fc32b,
  abstract     = {<p>Introduction: 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 &lt; 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 &lt; 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (-7.1 ± 21.0, P &lt; 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.</p>},
  author       = {Antonini, Angelo and Poewe, Werner and Chaudhuri, K. Ray and Jech, Robert and Pickut, Barbara and Pirtošek, Zvezdan and Szasz, Jozsef and Valldeoriola, Francesc and Winkler, Christian and Bergmann, Lars and Yegin, Ashley and Onuk, Koray and Barch, David and Odin, Per},
  issn         = {1353-8020},
  keyword      = {Levodopa-carbidopa intestinal gel,Motor symptoms,Non-motor symptoms,Parkinson's disease,Routine patient care},
  language     = {eng},
  publisher    = {Elsevier},
  series       = {Parkinsonism and Related Disorders},
  title        = {Levodopa-carbidopa intestinal gel in advanced Parkinson's : Final results of the GLORIA registry},
  url          = {http://dx.doi.org/10.1016/j.parkreldis.2017.09.018},
  year         = {2017},
}