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.
Highlights
Parkinson’s disease (PD) is a chronic, progressive neurodegenerative disorder characterized by motor impairments [1]
The aim of this observational study was to evaluate the clinical outcomes of a large Italian cohort of patients with advanced PD receiving levodopa/carbidopa intestinal gel (LCIG) in routine clinical care to evaluate the effects of therapy on both motor and non-motor 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
The mean age of patients was 70.4 ± 7.7 years, the mean duration of PD was 14.6 ± 6.6 years, and the mean time since the onset of motor fluctuations was 5.9 ± 4.0 years
Summary
Parkinson’s disease (PD) is a chronic, progressive neurodegenerative disorder characterized by motor impairments (tremor, rigidity, bradykinesia, and postural instability) [1]. 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]. Few studies have been conducted in a large population of patients with PD to assess the long-term outcome (over a period of[2 years) of treatment with LCIG [14, 15]. 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 non-motor 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. 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 PD
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