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Effects of Levodopa-Carbidopa Intestinal Gel on Dyskinesia and Non-Motor Symptoms Including Sleep : Results from a Meta-Analysis with 24-Month Follow-Up

Chaudhuri, K. Ray ; Antonini, Angelo ; Pahwa, Rajesh ; Odin, Per LU orcid ; Titova, Nataliya ; Thakkar, Sandeep ; Snedecor, Sonya J. ; Hegde, Saket ; Alobaidi, Ali and Parra, Juan Carlos , et al. (2022) In Journal of Parkinson's Disease 12(7). p.2071-2083
Abstract

Background: In advanced Parkinson's disease (PD), dyskinesias and non-motor symptoms such as sleep dysfunction can significantly impair quality of life, and high-quality management is an unmet need. Objective: To analyze changes in dyskinesia and non-motor symptoms (including sleep) among studies with levodopa-carbidopa intestinal gel (LCIG) in patients with advanced PD. Methods: A comprehensive literature review identified relevant studies examining LCIG efficacy. Outcomes of interest were dyskinesia (UDysRS, UPDRS IV item 32), overall non-motor symptoms (NMSS), mentation/behavior/mood (UPDRS I), and sleep/daytime sleepiness (PDSS-2, ESS). The pooled mean (95% confidence interval) change from baseline per outcome was estimated for each... (More)

Background: In advanced Parkinson's disease (PD), dyskinesias and non-motor symptoms such as sleep dysfunction can significantly impair quality of life, and high-quality management is an unmet need. Objective: To analyze changes in dyskinesia and non-motor symptoms (including sleep) among studies with levodopa-carbidopa intestinal gel (LCIG) in patients with advanced PD. Methods: A comprehensive literature review identified relevant studies examining LCIG efficacy. Outcomes of interest were dyskinesia (UDysRS, UPDRS IV item 32), overall non-motor symptoms (NMSS), mentation/behavior/mood (UPDRS I), and sleep/daytime sleepiness (PDSS-2, ESS). The pooled mean (95% confidence interval) change from baseline per outcome was estimated for each 3-month interval with sufficient data (i.e., reported by≥3 studies) up to 24 months using a random-effects model. Results: Seventeen open-label studies evaluating 1243 patients with advanced PD were included. All outcomes of interest with sufficient data for meta-analysis showed statistically significant improvement within 6 months of starting LCIG. There were statistically significant improvements in dyskinesia duration as measured by UPDRS IV item 32 at 6 months (-1.10 [-1.69, -0.51] h/day) and 12 months (-1.35 [-2.07, -0.62] h/day). There were statistically and clinically significant improvements in non-motor symptoms as measured by NMSS scores at 3 months (-28.71 [-40.26, -17.15] points). Significant reduction of NMSS burden was maintained through 24 months (-17.61 [-21.52, -13.70] points). UPDRS I scores significantly improved at 3 months (-0.39 [-0.55, -0.22] points). Clinically significant improvements in PDSS-2 and ESS scores were observed at 6 and 12 months in individual studies. Conclusion: Patients with advanced PD receiving LCIG showed significant sustained improvements in the burden of dyskinesia and non-motor symptoms up to 24 months after initiation.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
carbidopa/levodopa, meta-analysis, motor symptoms, Parkinson's disease, quality of life
in
Journal of Parkinson's Disease
volume
12
issue
7
pages
13 pages
publisher
IOS Press
external identifiers
  • scopus:85140143998
  • pmid:35964203
ISSN
1877-7171
DOI
10.3233/JPD-223295
language
English
LU publication?
yes
id
a1bf102d-1110-4a13-92b0-197aa5f700af
date added to LUP
2022-12-19 14:43:15
date last changed
2024-06-13 21:49:14
@article{a1bf102d-1110-4a13-92b0-197aa5f700af,
  abstract     = {{<p>Background: In advanced Parkinson's disease (PD), dyskinesias and non-motor symptoms such as sleep dysfunction can significantly impair quality of life, and high-quality management is an unmet need. Objective: To analyze changes in dyskinesia and non-motor symptoms (including sleep) among studies with levodopa-carbidopa intestinal gel (LCIG) in patients with advanced PD. Methods: A comprehensive literature review identified relevant studies examining LCIG efficacy. Outcomes of interest were dyskinesia (UDysRS, UPDRS IV item 32), overall non-motor symptoms (NMSS), mentation/behavior/mood (UPDRS I), and sleep/daytime sleepiness (PDSS-2, ESS). The pooled mean (95% confidence interval) change from baseline per outcome was estimated for each 3-month interval with sufficient data (i.e., reported by≥3 studies) up to 24 months using a random-effects model. Results: Seventeen open-label studies evaluating 1243 patients with advanced PD were included. All outcomes of interest with sufficient data for meta-analysis showed statistically significant improvement within 6 months of starting LCIG. There were statistically significant improvements in dyskinesia duration as measured by UPDRS IV item 32 at 6 months (-1.10 [-1.69, -0.51] h/day) and 12 months (-1.35 [-2.07, -0.62] h/day). There were statistically and clinically significant improvements in non-motor symptoms as measured by NMSS scores at 3 months (-28.71 [-40.26, -17.15] points). Significant reduction of NMSS burden was maintained through 24 months (-17.61 [-21.52, -13.70] points). UPDRS I scores significantly improved at 3 months (-0.39 [-0.55, -0.22] points). Clinically significant improvements in PDSS-2 and ESS scores were observed at 6 and 12 months in individual studies. Conclusion: Patients with advanced PD receiving LCIG showed significant sustained improvements in the burden of dyskinesia and non-motor symptoms up to 24 months after initiation.</p>}},
  author       = {{Chaudhuri, K. Ray and Antonini, Angelo and Pahwa, Rajesh and Odin, Per and Titova, Nataliya and Thakkar, Sandeep and Snedecor, Sonya J. and Hegde, Saket and Alobaidi, Ali and Parra, Juan Carlos and Zadikoff, Cindy and Bergmann, Lars and Standaert, David G.}},
  issn         = {{1877-7171}},
  keywords     = {{carbidopa/levodopa; meta-analysis; motor symptoms; Parkinson's disease; quality of life}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{2071--2083}},
  publisher    = {{IOS Press}},
  series       = {{Journal of Parkinson's Disease}},
  title        = {{Effects of Levodopa-Carbidopa Intestinal Gel on Dyskinesia and Non-Motor Symptoms Including Sleep : Results from a Meta-Analysis with 24-Month Follow-Up}},
  url          = {{http://dx.doi.org/10.3233/JPD-223295}},
  doi          = {{10.3233/JPD-223295}},
  volume       = {{12}},
  year         = {{2022}},
}