Authors: Leonardo Lopiano Nicola Modugno Pietro Marano Mariachiara Sensi Giuseppe Meco Antonino Cannas Graziano Gusmaroli Filippo Tamma Francesca Mancini Rocco Quatrale Anna Maria Costanzo Giuliana Gualberti Gabriella Melzi Umberto di Luzio Paparatti Angelo Antonini
Publish Date: 2016/07/15
Volume: 37, Issue: 11, Pages: 1785-1792
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 nonmotor 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 138 ± 166 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 21 ± 08 to 09 ± 07 57 reduction vs baseline P 00001 UPDRS IV improved by 39 P 00001 scores for dyskinesia duration and disability were reduced by 28 18 ± 10–13 ± 09 P 00001 and 33 15 ± 11 to 10 ± 10 P 00001 respectively and the scores for painful dyskinesia and early morning dystonia were reduced by 56 09 ± 10–04 ± 07 P 00001 and 25 04 ± 05–03 ± 05 P 0001 respectively The preliminary results of this interim analysis support the efficacy of LCIG on motor complications and activities of daily livingParkinson’s disease PD is a chronic progressive neurodegenerative disorder characterized by motor impairments tremor rigidity bradykinesia and postural instability 1 Further features include nonmotor symptoms such as cognitive dysfunction depression and sleep disorders 1 2 resulting in reduced quality of life 3 and negative effects on social interactions 3 4 Moreover patients with PD have a progressive loss of autonomy with a consequent impact on caregiver quality of lifeAs the disease progresses the response duration to levodopa shortens and the therapeutic window narrows resulting in unpredictable fluctuations with random and sudden ‘‘OFF’’ periods as well as disabling dyskinesia which exert a negative impact on the overall daily activities and quality of life 5 Motor and nonmotor symptoms reflect fluctuations in levodopa plasma concentrations due to the short halflife of levodopa and erratic absorption in relation with delayed gastric emptying 6Continuous dopaminergic drug delivery obtained with the administration of intraduodenal levodopa/carbidopa intestinal gel LCIG has been shown to provide a more stable plasma concentration of levodopa in patients with nonoptimal control of motor fluctuations 7 A number of studies have shown that LCIG leads to a significant reduction of OFF time and a significant increase of ON time as well as a reduction of dyskinesias 8 9 10 11 In addition improvements in nonmotor symptoms—and quality of life—were observed 12 13 However few studies have been conducted in a large population of patients with PD to assess the longterm outcome over a period of 2 years of treatment with LCIG 14 15 Therefore the aim of this observational study was to evaluate the clinical outcomes of a large Italian cohort of patients with advanced PD receiving LCIG in routine clinical care to evaluate the effects of therapy on both motor and nonmotor symptoms and the related impact on patient quality of life and caregiver burden from the initiation of LCIG therapy over a maximum exposure period of up to 9 years Here we present the interim results on motor symptoms and Unified Parkinson’s Disease Rating Scale UPDRS scores in this large cohort of patients with advanced PDInclusion criteria were being treated with LCIG the presence of adequate information about the previous medical history and treatment and the presence of at least one fulfilled scale or questionnaire among a selected list Patients could be enrolled at any time after LCIG treatment initiation Exclusion criteria were the presence of conditions that could have interfered with the longterm continuation of LCIG therapy at the physician’s discretion
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