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

Overview

Journal Neurol Sci

Specialty Neurology

Date 2020 Apr 29

PMID 32342325

Citations 3

Authors

Angelo Antonini

Pietro Marano

Graziano Gusmaroli

Nicola Modugno

Claudio Pacchetti

Mariachiara Sensi

Gabriella Melzi

Lars Bergmann

Maurizio Zibetti

Leonardo Lopiano

Affiliations

Soon will be listed here.

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.

Citing Articles

Invasive therapies for Parkinson's disease: an adapted excerpt from the guidelines of the German Society of Neurology.

Reese R, Koeglsperger T, Schrader C, Tonges L, Deuschl G, Kuhn A J Neurol. 2025; 272(3):219.

PMID: 39985674 PMC: 11846738. DOI: 10.1007/s00415-025-12915-6.

A 4-Year Follow-Up of Levodopa-Entacapone-Carbidopa Intestinal Gel Treatment in Parkinson's Disease.

Othman M, Nyholm D Mov Disord Clin Pract. 2024; 11(12):1609-1612.

PMID: 39445919 PMC: 11647987. DOI: 10.1002/mdc3.14240.

Initial Experience of the Levodopa-Entacapone-Carbidopa Intestinal Gel in Clinical Practice.

Othman M, Widman E, Nygren I, Nyholm D J Pers Med. 2021; 11(4).

PMID: 33807308 PMC: 8067183. DOI: 10.3390/jpm11040254.

From the Gut to the Brain and Back: Therapeutic Approaches for the Treatment of Network Dysfunction in Parkinson's Disease.

Paolone G Front Neurol. 2020; 11:557928.

PMID: 33117258 PMC: 7575743. DOI: 10.3389/fneur.2020.557928.

References

Contin M, Martinelli P . Pharmacokinetics of levodopa. J Neurol. 2010; 257(Suppl 2):S253-61. DOI: 10.1007/s00415-010-5728-8. View

Nyholm D, Askmark H, Gomes-Trolin C, Knutson T, Lennernas H, Nystrom C . Optimizing levodopa pharmacokinetics: intestinal infusion versus oral sustained-release tablets. Clin Neuropharmacol. 2003; 26(3):156-63. DOI: 10.1097/00002826-200305000-00010. View

Antonini A, Stoessl A, Kleinman L, Skalicky A, Marshall T, Sail K . Developing consensus among movement disorder specialists on clinical indicators for identification and management of advanced Parkinson's disease: a multi-country Delphi-panel approach. Curr Med Res Opin. 2018; 34(12):2063-2073. DOI: 10.1080/03007995.2018.1502165. View

Hauser R, Auinger P . Determination of minimal clinically important change in early and advanced Parkinson's disease. Mov Disord. 2011; 26(5):813-8. DOI: 10.1002/mds.23638. View

Olanow C, Kieburtz K, Odin P, Espay A, Standaert D, Fernandez H . Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 2013; 13(2):141-9. PMC: 4643396. DOI: 10.1016/S1474-4422(13)70293-X. View

Fernandez H, Standaert D, Hauser R, Lang A, Fung V, Klostermann F . Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: final 12-month, open-label results. Mov Disord. 2014; 30(4):500-9. PMC: 4674978. DOI: 10.1002/mds.26123. View

Fabbrini G, Brotchie J, Grandas F, Nomoto M, Goetz C . Levodopa-induced dyskinesias. Mov Disord. 2007; 22(10):1379-1389. DOI: 10.1002/mds.21475. View

Nyholm D, Odin P, Johansson A, Chatamra K, Locke C, Dutta S . Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson's disease patients. AAPS J. 2012; 15(2):316-23. PMC: 3675750. DOI: 10.1208/s12248-012-9439-1. View

Chapuis S, Ouchchane L, Metz O, Gerbaud L, Durif F . Impact of the motor complications of Parkinson's disease on the quality of life. Mov Disord. 2004; 20(2):224-30. DOI: 10.1002/mds.20279. View

10.

Antonini A, Poewe W, Chaudhuri K, Jech R, Pickut B, Pirtosek Z . Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry. Parkinsonism Relat Disord. 2017; 45:13-20. DOI: 10.1016/j.parkreldis.2017.09.018. View

11.

Antonini A, Yegin A, Preda C, Bergmann L, Poewe W . Global long-term study on motor and non-motor symptoms and safety of levodopa-carbidopa intestinal gel in routine care of advanced Parkinson's disease patients; 12-month interim outcomes. Parkinsonism Relat Disord. 2015; 21(3):231-5. DOI: 10.1016/j.parkreldis.2014.12.012. View

12.

E Palhagen S, Sydow O, Johansson A, Nyholm D, Holmberg B, Widner H . Levodopa-carbidopa intestinal gel (LCIG) treatment in routine care of patients with advanced Parkinson's disease: An open-label prospective observational study of effectiveness, tolerability and healthcare costs. Parkinsonism Relat Disord. 2016; 29:17-23. DOI: 10.1016/j.parkreldis.2016.06.002. View

13.

Buongiorno M, Antonelli F, Camara A, Puente V, de Fabregues-Nebot O, Hernandez-Vara J . Long-term response to continuous duodenal infusion of levodopa/carbidopa gel in patients with advanced Parkinson disease: The Barcelona registry. Parkinsonism Relat Disord. 2015; 21(8):871-6. DOI: 10.1016/j.parkreldis.2015.05.014. View

14.

Santos-Garcia D, de la Fuente-Fernandez R . Impact of non-motor symptoms on health-related and perceived quality of life in Parkinson's disease. J Neurol Sci. 2013; 332(1-2):136-40. DOI: 10.1016/j.jns.2013.07.005. View

15.

Tomlinson C, Stowe R, Patel S, Rick C, Gray R, Clarke C . Systematic review of levodopa dose equivalency reporting in Parkinson's disease. Mov Disord. 2010; 25(15):2649-53. DOI: 10.1002/mds.23429. View

16.

Antonini A, Odin P, Opiano L, Tomantschger V, Pacchetti C, Pickut B . Effect and safety of duodenal levodopa infusion in advanced Parkinson's disease: a retrospective multicenter outcome assessment in patient routine care. J Neural Transm (Vienna). 2013; 120(11):1553-8. DOI: 10.1007/s00702-013-1026-9. View

17.

Chaudhuri K, Odin P, Antonini A, Martinez-Martin P . Parkinson's disease: the non-motor issues. Parkinsonism Relat Disord. 2011; 17(10):717-23. DOI: 10.1016/j.parkreldis.2011.02.018. View

18.

Slevin J, Fernandez H, Zadikoff C, Hall C, Eaton S, Dubow J . Long-term safety and maintenance of efficacy of levodopa-carbidopa intestinal gel: an open-label extension of the double-blind pivotal study in advanced Parkinson's disease patients. J Parkinsons Dis. 2015; 5(1):165-74. DOI: 10.3233/JPD-140456. View

19.

Lundqvist C, Beiske A, Reiertsen O, Kristiansen I . Real life cost and quality of life associated with continuous intraduodenal levodopa infusion compared with oral treatment in Parkinson patients. J Neurol. 2014; 261(12):2438-45. DOI: 10.1007/s00415-014-7515-4. View

20.

Valldeoriola F, Grandas F, Santos-Garcia D, Regidor I, Catalan M, Arbelo J . Long-term effectiveness of levodopa-carbidopa intestinal gel in 177 Spanish patients with advanced Parkinson's disease. Neurodegener Dis Manag. 2016; 6(4):289-98. DOI: 10.2217/nmt-2016-0021. View