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

Leonardo Lopiano, Nicola Modugno, Pietro Marano, Mariachiara Sensi, G. Meco, Antonino Cannas, Graziano Gusmaroli, F. Tamma, Francesca Mancini, R. Quatrale, Anna Maria Costanzo, Giuliana Gualberti, Gabriella Melzi, Umberto di Luzio Paparatti, Angelo Antonini

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalNeurological Sciences
DOIs
Publication statusAccepted/In press - Jul 15 2016

Fingerprint

Italy
Observational Studies
Parkinson Disease
Gels
Dyskinesias
Quality of Life
Dystonia
Movement Disorders
Activities of Daily Living
Motor Activity
levodopa drug combination carbidopa
Therapeutics
Population

Keywords

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

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health
  • Dermatology

Cite this

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. / Lopiano, Leonardo; Modugno, Nicola; Marano, Pietro; Sensi, Mariachiara; Meco, G.; Cannas, Antonino; Gusmaroli, Graziano; Tamma, F.; Mancini, Francesca; Quatrale, R.; Costanzo, Anna Maria; Gualberti, Giuliana; Melzi, Gabriella; di Luzio Paparatti, Umberto; Antonini, Angelo.

In: Neurological Sciences, 15.07.2016, p. 1-8.

Research output: Contribution to journalArticle

Lopiano, L, Modugno, N, Marano, P, Sensi, M, Meco, G, Cannas, A, Gusmaroli, G, Tamma, F, Mancini, F, Quatrale, R, Costanzo, AM, Gualberti, G, Melzi, G, di Luzio Paparatti, U & Antonini, A 2016, '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', Neurological Sciences, pp. 1-8. https://doi.org/10.1007/s10072-016-2664-0
Lopiano, Leonardo ; Modugno, Nicola ; Marano, Pietro ; Sensi, Mariachiara ; Meco, G. ; Cannas, Antonino ; Gusmaroli, Graziano ; Tamma, F. ; Mancini, Francesca ; Quatrale, R. ; Costanzo, Anna Maria ; Gualberti, Giuliana ; Melzi, Gabriella ; di Luzio Paparatti, Umberto ; Antonini, Angelo. / 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. In: Neurological Sciences. 2016 ; pp. 1-8.
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AU - Marano, Pietro

AU - Sensi, Mariachiara

AU - Meco, G.

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AU - Costanzo, Anna Maria

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