An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients

Rejko Krüger, Paul Lingor, Triantafyllos Doskas, Johanna M.L. Henselmans, Erik H. Danielsen, Oriol de Fabregues, Alessandro Stefani, Sven Christian Sensken, Juan Carlos Parra, Koray Onuk, Ashley Yegin, Angelo Antonini

Research output: Contribution to journalArticle

Abstract

Introduction: Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. Methods: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8. Results: The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event. Conclusion: This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG. Funding: AbbVie Inc.

Original languageEnglish
Pages (from-to)1741-1752
Number of pages12
JournalAdvances in Therapy
Volume34
Issue number7
DOIs
Publication statusPublished - Jul 1 2017

Fingerprint

Activities of Daily Living
Observational Studies
Parkinson Disease
Gels
Quality of Life
Gastric Bypass
Dyskinesias
Levodopa
Cognition
Fatigue
Gastrointestinal Tract
Sleep
Prospective Studies
Therapeutics

Keywords

  • Activities of daily living
  • Levodopa–carbidopa intestinal gel
  • Parkinson’s disease
  • Percutaneous endoscopic gastrojejunostomy
  • Quality of life

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients. / Krüger, Rejko; Lingor, Paul; Doskas, Triantafyllos; Henselmans, Johanna M.L.; Danielsen, Erik H.; de Fabregues, Oriol; Stefani, Alessandro; Sensken, Sven Christian; Parra, Juan Carlos; Onuk, Koray; Yegin, Ashley; Antonini, Angelo.

In: Advances in Therapy, Vol. 34, No. 7, 01.07.2017, p. 1741-1752.

Research output: Contribution to journalArticle

Krüger, R, Lingor, P, Doskas, T, Henselmans, JML, Danielsen, EH, de Fabregues, O, Stefani, A, Sensken, SC, Parra, JC, Onuk, K, Yegin, A & Antonini, A 2017, 'An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients', Advances in Therapy, vol. 34, no. 7, pp. 1741-1752. https://doi.org/10.1007/s12325-017-0571-2
Krüger, Rejko ; Lingor, Paul ; Doskas, Triantafyllos ; Henselmans, Johanna M.L. ; Danielsen, Erik H. ; de Fabregues, Oriol ; Stefani, Alessandro ; Sensken, Sven Christian ; Parra, Juan Carlos ; Onuk, Koray ; Yegin, Ashley ; Antonini, Angelo. / An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients. In: Advances in Therapy. 2017 ; Vol. 34, No. 7. pp. 1741-1752.
@article{a0136a4bb1a54e02a8af6080ad6eb9f0,
title = "An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients",
abstract = "Introduction: Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. Methods: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8. Results: The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8{\%}) experienced an adverse event; 21.9{\%} experienced a serious adverse event; 11.1{\%} discontinued because of an adverse event. Conclusion: This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG. Funding: AbbVie Inc.",
keywords = "Activities of daily living, Levodopa–carbidopa intestinal gel, Parkinson’s disease, Percutaneous endoscopic gastrojejunostomy, Quality of life",
author = "Rejko Kr{\"u}ger and Paul Lingor and Triantafyllos Doskas and Henselmans, {Johanna M.L.} and Danielsen, {Erik H.} and {de Fabregues}, Oriol and Alessandro Stefani and Sensken, {Sven Christian} and Parra, {Juan Carlos} and Koray Onuk and Ashley Yegin and Angelo Antonini",
year = "2017",
month = "7",
day = "1",
doi = "10.1007/s12325-017-0571-2",
language = "English",
volume = "34",
pages = "1741--1752",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Springer Healthcare",
number = "7",

}

TY - JOUR

T1 - An Observational Study of the Effect of Levodopa–Carbidopa Intestinal Gel on Activities of Daily Living and Quality of Life in Advanced Parkinson’s Disease Patients

AU - Krüger, Rejko

AU - Lingor, Paul

AU - Doskas, Triantafyllos

AU - Henselmans, Johanna M.L.

AU - Danielsen, Erik H.

AU - de Fabregues, Oriol

AU - Stefani, Alessandro

AU - Sensken, Sven Christian

AU - Parra, Juan Carlos

AU - Onuk, Koray

AU - Yegin, Ashley

AU - Antonini, Angelo

PY - 2017/7/1

Y1 - 2017/7/1

N2 - Introduction: Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. Methods: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8. Results: The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event. Conclusion: This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG. Funding: AbbVie Inc.

AB - Introduction: Continuous delivery of levodopa–carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson’s disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations (“on” and “off” states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. Methods: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2–4 h of “off” time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8. Results: The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event. Conclusion: This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG. Funding: AbbVie Inc.

KW - Activities of daily living

KW - Levodopa–carbidopa intestinal gel

KW - Parkinson’s disease

KW - Percutaneous endoscopic gastrojejunostomy

KW - Quality of life

UR - http://www.scopus.com/inward/record.url?scp=85021143613&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85021143613&partnerID=8YFLogxK

U2 - 10.1007/s12325-017-0571-2

DO - 10.1007/s12325-017-0571-2

M3 - Article

C2 - 28631218

AN - SCOPUS:85021143613

VL - 34

SP - 1741

EP - 1752

JO - Advances in Therapy

JF - Advances in Therapy

SN - 0741-238X

IS - 7

ER -