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 (Tübingen, Germany)
Lingor, Paul (Göttingen, Germany)
Doskas, Triantafyllos (Athens, Greece)
Henselmans, Johanna M. L. (Leiden, The Netherlands)
Danielsen, Erik H. (Aarhus, Denmark)
Fàbregues-Boixar i Nebot, Oriol de (Hospital Universitari Vall d'Hebron)
Stefani, Alessandro (Rome, Italy)
Sensken, Sven-Christian (Wiesbaden, Germany)
Parra, Juan Carlos (Waukegan Road, North Chicago, IL USA)
Onuk, Koray (Waukegan Road, North Chicago, IL USA)
Yegin, Ashley (Waukegan Road, North Chicago, IL USA)
Antonini, Angelo (University Hospital of Padova (Pàdua, Itàlia))
Universitat Autònoma de Barcelona

Data:	2017
Resum:	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. 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. 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. 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. AbbVie Inc. The online version of this article (doi:10. 1007/s12325-017-0571-2) contains supplementary material, which is available to authorized users.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Activities of daily living ; Levodopa-carbidopa intestinal gel ; Parkinson's disease ; Percutaneous endoscopic gastrojejunostomy ; Quality of life
Publicat a:	Advances in Therapy, Vol. 34 (june 2017) , p. 1741-1752, ISSN 1865-8652

DOI: 10.1007/s12325-017-0571-2
PMID: 28631218

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