Motor and non-motor outcomes in patients with advanced Parkinson's disease treated with levodopa/carbidopa intestinal gel: final results of the GREENFIELD observational study

Leonardo Lopiano, Nicola Modugno, Pietro Marano, Mariachiara Sensi, Giuseppe Meco, Paolo Solla, Graziano Gusmaroli, Filippo Tamma, Francesca Mancini, Rocco Quatrale, Roberta Zangaglia, Annarita Bentivoglio, Roberto Eleopra, Giuliana Gualberti, Gabriella Melzi, Angelo Antonini

Research output: Contribution to journalArticle

Abstract

INTRODUCTION: The GREENFIELD observational study assessed the effect of levodopa/carbidopa intestinal gel (LCIG) on motor and non-motor symptoms, and the related impact on patient quality of life and caregiver burden up to 8 years.

METHODS: Final results of a large Italian cohort of patients who started LCIG in routine care between 2007 and 2014 are presented. Comparison between baseline (before LCIG) and follow-up visits on yearly basis (visit 2/3) is reported. Primary endpoint was Unified Parkinson's Disease Rating Scale (UPDRS-IV) Item 39; secondary endpoints were UPDRS I and II, dyskinesia items, PD Quality of Life Questionnaire-39, Parkinson's Disease Sleep Scale-2, Gait and Falls Questionnaire, Questionnaire on Impulsive Disorders, and Relative Stress Scale.

RESULTS: Overall, 145 patients from 14 centers were assessed with a mean time since LCIG start of 2.8 ± 1.7 years at visit 2. The mean UPDRS-IV item 39 score showed significant reductions compared to baseline (mean score 2.0 ± 0.81) at visit 2 (mean score 0.9 ± 0.69; - 55%; p < 0.001) and at visit 3 (mean score 1.0 ± 0.75; - 50%; p < 0.001). At visit 3, significant reductions were observed for dyskinesia duration score (- 28%; p < 0.001), dyskinesia disability (- 40%; p < 0.001), and painful dyskinesia (- 50%; p < 0.001). Overall, 40 (27.6%) patients experienced 49 serious adverse events which were considered related to PEG/J procedure or to device in 16.3% of the cases.

CONCLUSIONS: The results of this study support the long-term efficacy of LCIG on PD symptoms as well as on activities of daily living. The adverse events were consistent with the established LCIG safety profile.

Original languageEnglish
Pages (from-to)2164-76
Number of pages12
JournalJournal of Neurology
Volume266
Issue number9
DOIs
Publication statusPublished - May 27 2019

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    Lopiano, L., Modugno, N., Marano, P., Sensi, M., Meco, G., Solla, P., Gusmaroli, G., Tamma, F., Mancini, F., Quatrale, R., Zangaglia, R., Bentivoglio, A., Eleopra, R., Gualberti, G., Melzi, G., & Antonini, A. (2019). Motor and non-motor outcomes in patients with advanced Parkinson's disease treated with levodopa/carbidopa intestinal gel: final results of the GREENFIELD observational study. Journal of Neurology, 266(9), 2164-76. https://doi.org/10.1007/s00415-019-09337-6