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

Anna Rita Bentivoglio, Federico Mancini, L Lopiano, N Modugno, P Marano, M Sensi, G Meco, P Solla, G Gusmaroli, F Tamma, R Quatrale, R Zangaglia, R Eleopra, G Gualberti, G Melzi, A Antonini

Risultato della ricerca: Contributo in rivistaArticolo in rivista

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.
Lingua originaleEnglish
pagine (da-a)2164-2176
Numero di pagine13
RivistaJournal of Neurology
Volume266
Stato di pubblicazionePubblicato - 2019

Keywords

  • Advanced Parkinson's disease
  • Intestinal infusion
  • Levodopa
  • Motor symptoms
  • Quality of life
  • Routine patient care
  • carbidopa

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