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Observational Study
. 2017 Jul;34(7):1741-1752.
doi: 10.1007/s12325-017-0571-2. Epub 2017 Jun 19.

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  1   2   3 , Paul Lingor  4 , Triantafyllos Doskas  5 , Johanna M L Henselmans  6 , Erik H Danielsen  7 , Oriol de Fabregues  8 , Alessandro Stefani  9 , Sven-Christian Sensken  10 , Juan Carlos Parra  11 , Koray Onuk  11 , Ashley Yegin  11 , Angelo Antonini  12
Affiliations
Observational Study

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 et al. Adv Ther. 2017 Jul.

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.

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Figures

Fig. 1
Fig. 1
Patient disposition from enrollment to day 1 post PEG-J placement. LCIG levodopa–carbidopa intestinal gel, PEG-J percutaneous endoscopic gastrojejunostomy
Fig. 2
Fig. 2
Mean (SD) change from baseline in measures of activities of daily living in the LCIG treatment group. Activities of daily living were measured by UPDRS Part II total score during the best “on” time. Statistical significance compared with baseline is indicated at p ≤ 0.05 (single asterisk) and p ≤ 0.0001 (triple asterisk). “Final” is the last observation carried forward. LCIG levodopa–carbidopa intestinal gel, UPDRS Unified Parkinson’s Disease Rating Scale
Fig. 3
Fig. 3
Mean (SD) change from baseline in measures of a motor symptoms, b quality of life, and c non-motor symptoms in the LCIG treatment group. Motor symptoms were measured by UPDRS Part III total score during the best “on” time; quality of life was measured by PDQ-8 summary index score; non-motor symptoms were measured using the NMSS total score. Statistical significance compared with baseline is indicated at p ≤ 0.01 (double asterisk) and p ≤ 0.0001 (triple asterisk). “Final” is the last observation carried forward. LCIG levodopa–carbidopa intestinal gel, NMSS Non-Motor Symptom Scale, PDQ-8 Parkinson’s disease questionnaire, UPDRS Unified Parkinson’s Disease Rating Scale
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