title: Motor outcomes in patients with advanced Parkinson's disease treated with levodopa/carbidopa intestinal gel in Italy: an interim analysis from the GREENFIELD observational study.
abstract: Several levodopa/carbidopa intestinal gel (LCIG) studies showed a significant reduction of OFF time and a significant increase of ON time, as well as a reduction of dyskinesia, and improvement of non-motor symptoms and quality of life. However, few studies have been conducted in a large population for more than 3 years. Interim outcomes from GREENFIELD observational study on a large Italian cohort of advanced PD patients who started LCIG in routine care between 2007 and 2014, still on treatment at the enrollment, are presented. Comparison between baseline (before LCIG start) and visit 1 (at enrollment) is reported. Primary endpoint was Unified Parkinson's Disease Rating Scale (UPDRS) IV Item 39; secondary endpoints were UPDRS I and II, as outcome of quality of life. Overall, 145 of 148 enrolled patients from 14 Movement Disorder Centers in Italy were evaluable with a mean LCIG treatment period of 1.38 ± 1.66 years at enrollment. Compared with baseline, the mean score regarding daily time spent in OFF (UPDRS IV Item 39) at visit 1 significantly decreased from 2.1 ± 0.8 to 0.9 ± 0.7 (57 % reduction vs baseline, P < 0.0001); UPDRS IV improved by 39 % (P < 0.0001); scores for dyskinesia duration and disability were reduced by 28 % (1.8 ± 1.0-1.3 ± 0.9; P < 0.0001) and 33 % (1.5 ± 1.1 to 1.0 ± 1.0; P < 0.0001), respectively; and the scores for painful dyskinesia and early morning dystonia were reduced by 56 % (0.9 ± 1.0-0.4 ± 0.7; P < 0.0001) and 25 % (0.4 ± 0.5-0.3 ± 0.5; P < 0.001), respectively. The preliminary results of this interim analysis support the efficacy of LCIG on motor complications and activities of daily living.
authors.affiliation: Department of Neuroscience, University of Torino, Torino, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Lopiano
authors.affiliation: Neurology Department, IRCCS Neuromed, Pozzilli (IS), Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Modugno
authors.affiliation: Neurorehabilitation Unit, Casa di Cura Villa dei Gerani, Catania, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Marano
authors.affiliation: Neurology Unit, Hospital Sant'Anna, Ferrara, Italy.
authors.forename: Mariachiara
authors.initials: M
authors.lastname: Sensi
authors.affiliation: Department of Neurology and Psychiatry (Parkinson's Centre) and Research Centre of Social Diseases (CIMS), Sapienza University, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Meco
authors.affiliation: Neurology Unit, Policlinico Universitario Monserrato, Cagliari, Italy.
authors.forename: Antonino
authors.initials: A
authors.lastname: Cannas
authors.affiliation: Neurology Unit, Ospedale degli Infermi, Biella, Italy.
authors.forename: Graziano
authors.initials: G
authors.lastname: Gusmaroli
authors.affiliation: Neurology Unit, Miulli Hospital, Acquaviva delle Fonti (BA), Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Tamma
authors.affiliation: Parkinson Disease and Movement Disorders Centre, Neurology Unit, S.Pio X Clinic, Milan, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Mancini
authors.affiliation: Neurology Unit, Hospital dell'Angelo, Mestre (VE), Italy.
authors.forename: Rocco
authors.initials: R
authors.lastname: Quatrale
authors.affiliation: AbbVie Srl, Campoverde (LT), Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Costanzo
authors.affiliation: AbbVie Srl, Campoverde (LT), Italy.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Gualberti
authors.affiliation: AbbVie Srl, Campoverde (LT), Italy. gabriella.melzi@abbvie.com.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Melzi
authors.affiliation: AbbVie Srl, Campoverde (LT), Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: di Luzio Paparatti
authors.affiliation: Parkinson and Movement Disorder Unit, IRCCS Hospital San Camillo, Venice, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Antonini
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000494:pharmacology*; D002230:Carbidopa / Q000008:administration & dosage / Q000494:pharmacology*; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D007263:Infusions, Parenteral; D007558:Italy; D007980:Levodopa / Q000008:administration & dosage / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010300:Parkinson Disease / Q000188:drug therapy*; D011788:Quality of Life
chemical_list: D000978:Antiparkinson Agents; D004338:Drug Combinations; D005782:Gels; C009265:carbidopa, levodopa drug combination; D007980:Levodopa; D002230:Carbidopa
keywords: Advanced Parkinson’s disease; Intestinal infusion; Levodopa–carbidopa; Motor symptoms; Quality of life; Routine patient care