Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease: results of the Italian GLORIA patient population

Angelo Antonini; Pietro Marano; Graziano Gusmaroli; Nicola Modugno; Claudio Pacchetti; Mariachiara Sensi; Gabriella Melzi; Lars Bergmann; Maurizio Zibetti; Leonardo Lopiano

doi:10.1007/s10072-020-04401-w

Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease: results of the Italian GLORIA patient population

Angelo Antonini, Pietro Marano, Graziano Gusmaroli, Nicola Modugno, Claudio Pacchetti, Mariachiara Sensi, Gabriella Melzi, Lars Bergmann, Maurizio Zibetti, Leonardo Lopiano

Research output: Contribution to journal › Article

Abstract

INTRODUCTION: The GLORIA registry included 375 advanced Parkinson's disease (PD) patients and evaluated the efficacy and safety of a 24-month levodopa-carbidopa intestinal gel (LCIG) treatment in routine medical care. This analysis focuses on the Italian population, 60 patients treated with LCIG in 7 specialised PD care centres.

METHODS: Hours of "Off" and "On" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV items 39 and 32. Motor fluctuations, dyskinesia, non-motor symptoms, quality of life and safety were evaluated.

RESULTS: Overall, 42 (70%) out of 60 patients completed the registry. LCIG treatment reduced "Off" time (- 3.3 ± 2.7 h at month 24 (M24), P < 0.0001), increased "On" time with dyskinesia (- 2.6 ± 5.2 h at M12, P = 0.0160), and improved UPDRS II and UPDRS III total scores at M24 (- 4.5 ± 10.6, P = 0.0333 and - 4.9 ± 11.7, P = 0.0229, respectively), Non-Motor Symptom Scale (NMSS) total score (- 21.8 ± 28.5, P < 0.0001) and Parkinson's Disease Questionnaire-8 item (PDQ-8) total score (- 12.5 ± 23.9, P = 0.0173) versus previous oral therapy. Adverse drug reactions (ADR) possibly or probably related to treatment were reported in 16 (28.6%) patients. Decreased weight (7.1%), polyneuropathy (7.1%) and abdominal pain (5.4%) were the most frequent ADRs while device malfunction (5.4%) and medical device change (5.4%) were the most reported device complaints.

CONCLUSIONS: LCIG improved motor fluctuations, non-motor symptoms and quality of life over 24 months while tolerability was consistent with the established safety profile.

Original language	English
Pages (from-to)	2929-37
Number of pages	8
Journal	Neurol. Sci.
Volume	41
Issue number	10
DOIs	https://doi.org/10.1007/s10072-020-04401-w
Publication status	Published - Apr 28 2020

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Antonini, A., Marano, P., Gusmaroli, G., Modugno, N., Pacchetti, C., Sensi, M., Melzi, G., Bergmann, L., Zibetti, M., & Lopiano, L. (2020). Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease: results of the Italian GLORIA patient population. Neurol. Sci., 41(10), 2929-37. https://doi.org/10.1007/s10072-020-04401-w

Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease : results of the Italian GLORIA patient population. / Antonini, Angelo; Marano, Pietro; Gusmaroli, Graziano; Modugno, Nicola ; Pacchetti, Claudio; Sensi, Mariachiara; Melzi, Gabriella; Bergmann, Lars; Zibetti, Maurizio; Lopiano, Leonardo.

In: Neurol. Sci., Vol. 41, No. 10, 28.04.2020, p. 2929-37.

Research output: Contribution to journal › Article

Antonini, A, Marano, P, Gusmaroli, G, Modugno, N , Pacchetti, C, Sensi, M, Melzi, G, Bergmann, L, Zibetti, M & Lopiano, L 2020, 'Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease: results of the Italian GLORIA patient population', Neurol. Sci., vol. 41, no. 10, pp. 2929-37. https://doi.org/10.1007/s10072-020-04401-w

Antonini, Angelo ; Marano, Pietro ; Gusmaroli, Graziano ; Modugno, Nicola ; Pacchetti, Claudio ; Sensi, Mariachiara ; Melzi, Gabriella ; Bergmann, Lars ; Zibetti, Maurizio ; Lopiano, Leonardo. / Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease : results of the Italian GLORIA patient population. In: Neurol. Sci. 2020 ; Vol. 41, No. 10. pp. 2929-37.

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title = "Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease: results of the Italian GLORIA patient population",

abstract = "INTRODUCTION: The GLORIA registry included 375 advanced Parkinson's disease (PD) patients and evaluated the efficacy and safety of a 24-month levodopa-carbidopa intestinal gel (LCIG) treatment in routine medical care. This analysis focuses on the Italian population, 60 patients treated with LCIG in 7 specialised PD care centres.METHODS: Hours of {"}Off{"} and {"}On{"} time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV items 39 and 32. Motor fluctuations, dyskinesia, non-motor symptoms, quality of life and safety were evaluated.RESULTS: Overall, 42 (70%) out of 60 patients completed the registry. LCIG treatment reduced {"}Off{"} time (- 3.3 ± 2.7 h at month 24 (M24), P < 0.0001), increased {"}On{"} time with dyskinesia (- 2.6 ± 5.2 h at M12, P = 0.0160), and improved UPDRS II and UPDRS III total scores at M24 (- 4.5 ± 10.6, P = 0.0333 and - 4.9 ± 11.7, P = 0.0229, respectively), Non-Motor Symptom Scale (NMSS) total score (- 21.8 ± 28.5, P < 0.0001) and Parkinson's Disease Questionnaire-8 item (PDQ-8) total score (- 12.5 ± 23.9, P = 0.0173) versus previous oral therapy. Adverse drug reactions (ADR) possibly or probably related to treatment were reported in 16 (28.6%) patients. Decreased weight (7.1%), polyneuropathy (7.1%) and abdominal pain (5.4%) were the most frequent ADRs while device malfunction (5.4%) and medical device change (5.4%) were the most reported device complaints.CONCLUSIONS: LCIG improved motor fluctuations, non-motor symptoms and quality of life over 24 months while tolerability was consistent with the established safety profile.",

author = "Angelo Antonini and Pietro Marano and Graziano Gusmaroli and Nicola Modugno and Claudio Pacchetti and Mariachiara Sensi and Gabriella Melzi and Lars Bergmann and Maurizio Zibetti and Leonardo Lopiano",

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T1 - Long-term effectiveness of levodopa-carbidopa intestinal gel on motor and non-motor symptoms in advanced Parkinson's disease

T2 - results of the Italian GLORIA patient population

AU - Antonini, Angelo

AU - Marano, Pietro

AU - Gusmaroli, Graziano

AU - Modugno, Nicola

AU - Pacchetti, Claudio

AU - Sensi, Mariachiara

AU - Melzi, Gabriella

AU - Bergmann, Lars

AU - Zibetti, Maurizio

AU - Lopiano, Leonardo

PY - 2020/4/28

Y1 - 2020/4/28

N2 - INTRODUCTION: The GLORIA registry included 375 advanced Parkinson's disease (PD) patients and evaluated the efficacy and safety of a 24-month levodopa-carbidopa intestinal gel (LCIG) treatment in routine medical care. This analysis focuses on the Italian population, 60 patients treated with LCIG in 7 specialised PD care centres.METHODS: Hours of "Off" and "On" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV items 39 and 32. Motor fluctuations, dyskinesia, non-motor symptoms, quality of life and safety were evaluated.RESULTS: Overall, 42 (70%) out of 60 patients completed the registry. LCIG treatment reduced "Off" time (- 3.3 ± 2.7 h at month 24 (M24), P < 0.0001), increased "On" time with dyskinesia (- 2.6 ± 5.2 h at M12, P = 0.0160), and improved UPDRS II and UPDRS III total scores at M24 (- 4.5 ± 10.6, P = 0.0333 and - 4.9 ± 11.7, P = 0.0229, respectively), Non-Motor Symptom Scale (NMSS) total score (- 21.8 ± 28.5, P < 0.0001) and Parkinson's Disease Questionnaire-8 item (PDQ-8) total score (- 12.5 ± 23.9, P = 0.0173) versus previous oral therapy. Adverse drug reactions (ADR) possibly or probably related to treatment were reported in 16 (28.6%) patients. Decreased weight (7.1%), polyneuropathy (7.1%) and abdominal pain (5.4%) were the most frequent ADRs while device malfunction (5.4%) and medical device change (5.4%) were the most reported device complaints.CONCLUSIONS: LCIG improved motor fluctuations, non-motor symptoms and quality of life over 24 months while tolerability was consistent with the established safety profile.

AB - INTRODUCTION: The GLORIA registry included 375 advanced Parkinson's disease (PD) patients and evaluated the efficacy and safety of a 24-month levodopa-carbidopa intestinal gel (LCIG) treatment in routine medical care. This analysis focuses on the Italian population, 60 patients treated with LCIG in 7 specialised PD care centres.METHODS: Hours of "Off" and "On" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV items 39 and 32. Motor fluctuations, dyskinesia, non-motor symptoms, quality of life and safety were evaluated.RESULTS: Overall, 42 (70%) out of 60 patients completed the registry. LCIG treatment reduced "Off" time (- 3.3 ± 2.7 h at month 24 (M24), P < 0.0001), increased "On" time with dyskinesia (- 2.6 ± 5.2 h at M12, P = 0.0160), and improved UPDRS II and UPDRS III total scores at M24 (- 4.5 ± 10.6, P = 0.0333 and - 4.9 ± 11.7, P = 0.0229, respectively), Non-Motor Symptom Scale (NMSS) total score (- 21.8 ± 28.5, P < 0.0001) and Parkinson's Disease Questionnaire-8 item (PDQ-8) total score (- 12.5 ± 23.9, P = 0.0173) versus previous oral therapy. Adverse drug reactions (ADR) possibly or probably related to treatment were reported in 16 (28.6%) patients. Decreased weight (7.1%), polyneuropathy (7.1%) and abdominal pain (5.4%) were the most frequent ADRs while device malfunction (5.4%) and medical device change (5.4%) were the most reported device complaints.CONCLUSIONS: LCIG improved motor fluctuations, non-motor symptoms and quality of life over 24 months while tolerability was consistent with the established safety profile.

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DO - 10.1007/s10072-020-04401-w

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