TY - JOUR
T1 - 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
AU - Lopiano, L
AU - Modugno, N
AU - Marano, P
AU - Sensi, M
AU - Meco, G
AU - Solla, P
AU - Gusmaroli, G
AU - Tamma, F
AU - Mancini, F
AU - Quatrale, R
AU - Zangaglia, R
AU - Bentivoglio, Anna Rita
AU - Eleopra, R
AU - Gualberti, G
AU - Melzi, G
AU - Antonini, A
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
KW - Advanced Parkinson's disease
KW - Intestinal infusion
KW - Levodopa
KW - Motor symptoms
KW - Quality of life
KW - Routine patient care
KW - carbidopa
KW - Advanced Parkinson's disease
KW - Intestinal infusion
KW - Levodopa
KW - Motor symptoms
KW - Quality of life
KW - Routine patient care
KW - carbidopa
UR - https://publicatt.unicatt.it/handle/10807/171584
UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85070443929&origin=inward
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85070443929&origin=inward
U2 - 10.1007/s00415-019-09337-6
DO - 10.1007/s00415-019-09337-6
M3 - Article
SN - 0340-5354
VL - 266
SP - 2164
EP - 2176
JO - Journal of Neurology
JF - Journal of Neurology
IS - 9
ER -