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.
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.
['Lopiano|Leonardo|L|', 'Modugno|Nicola|N|', 'Marano|Pietro|P|', 'Sensi|Mariachiara|M|', 'Meco|Giuseppe|G|', 'Cannas|Antonino|A|', 'Gusmaroli|Graziano|G|', 'Tamma|Filippo|F|', 'Mancini|Francesca|F|', 'Quatrale|Rocco|R|', 'Costanzo|Anna Maria|AM|', 'Gualberti|Giuliana|G|', 'Melzi|Gabriella|G|', 'di Luzio Paparatti|Umberto|U|', 'Antonini|Angelo|A|']
D000203:Activities of Daily Living D000368:Aged D000369:Aged, 80 and over D000978:Antiparkinson Agents D002230:Carbidopa D004338:Drug Combinations D005260:Female D005782:Gels D006801:Humans D007263:Infusions, Parenteral D007558:Italy D007980:Levodopa D008297:Male D008875:Middle Aged D017063:Outcome Assessment, Health Care D010300:Parkinson Disease D011788:Quality of Life
Quality of life Advanced Parkinson’s disease Intestinal infusion Levodopa–carbidopa Motor symptoms Routine patient care