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.

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 / 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.. - In: JOURNAL OF NEUROLOGY. - ISSN 0340-5354. - 266:9(2019), pp. 2164-2176. [10.1007/s00415-019-09337-6]

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

Solla P.;
2019-01-01

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.
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 / 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.. - In: JOURNAL OF NEUROLOGY. - ISSN 0340-5354. - 266:9(2019), pp. 2164-2176. [10.1007/s00415-019-09337-6]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11388/245312
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