Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry

Angelo Antonini, Werner Poewe, K. Ray Chaudhuri, Robert Jech, Barbara Pickut, Zvezdan Pirtošek, Jozsef Szasz, Francesc Valldeoriola, Christian Winkler, Lars Bergmann, Ashley Yegin, Koray Onuk, David Barch, Per Odin, Ene Amalia, Guy Arnold, Ovidiu Bajenaru, Bruno Bergmans, Kari Anne Bjornara, Jeff BlackieMatthias Bode, Paul Bourgeois, Stephan Bohlhalter, Ioan Buraga, Pierre R. Burkhard, Philippe Busson, Matilde Calopa, Jesper Clausen, Erik Hvid Danielsen, Luc Defebvre, Valerie Delvaux, Sophie Dethy, Espen Dietrichs, Oriol De Fabregues, Ransmayr Gerhard, Graziano Gusmaroli, Kirsten Hahn, Björn Hauptmann, Tove Henriksen, Jorge Hernandez-Vara, A. Jeanjean, Michaela Kaiserova, Jan Kassubek, Thomas Kimber, Spyridon Konitsiotis, Rejko Krüger, Jaime Kulisevsky, Jo Leenders, Christofer Lundqvist, F. Ory Magne, Pietro Marano, Ivan Milanov, Nicola Modugno, Anjum Misbahuddin, Martin Nevrly, Zikos Panayiotis, Kenn Freddy Pedersen, Stephen W. Pedersen, Lacramioara Perju-Dumbrava, M. M. Ponsen, Bogdan O. Popescu, Michel Rijntjes, V. Puente, Christoph Redecker, Christoph Schrader, Mariachiara Sensi, Mihaela Simu, Cleanthe Spanaki, Alexander Storch, Anette Storstein, Volker Tomantschger, Chris van der Linden, T. van Laar, F. Viallet, Tatiana Witjas, Martin Wolz, Maurizio Zibetti, Michel Van Zandijcke

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Abstract

© 2017 The Authors Introduction This registry evaluated the 24-month safety and efficacy of levodopa-carbidopa intestinal gel (LCIG) treatment in advanced Parkinson's disease (PD) patients under routine clinical care. Methods Motor fluctuations, dyskinesia, non-motor symptoms, quality of life, and safety were evaluated. Observations were fully prospective for treatment-naïve patients (60% of patients) and partially retrospective for patients with ≤12 months of pre-treatment with LCIG (40% of patients). Hours of “On” and “Off” time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale part IV items 32 and 39. Results Overall, 375 patients were enrolled by 75 movement disorder centers in 18 countries and 258 patients completed the registry. At 24 months LCIG treatment led to significant reductions from baseline in “Off” time (hours/day) (mean ± SD = −4.1 ± 3.5, P < 0.001), “On” time with dyskinesia (hours/day) (−1.1 ± 4.8, P = 0.006), Non-Motor Symptom Scale total (−16.7 ± 43.2, P < 0.001) and individual domains scores, and Parkinson's Disease Questionnaire-8 item total score (−7.1 ± 21.0, P < 0.001). Adverse events deemed to have a possible/probable causal relationship to treatment drug/device were reported in 194 (54%) patients; the most frequently reported were decreased weight (6.7%), device related infections (5.9%), device dislocations (4.8%), device issues (4.8%), and polyneuropathy (4.5%). Conclusions LCIG treatment led to sustained improvements in motor fluctuations, non-motor symptoms particularly sleep/fatigue, mood/cognition and gastrointestinal domains, as well as quality of life in advanced PD patients over 24 months. Safety events were consistent with the established safety profile of LCIG.
Original languageEnglish
Pages (from-to)13-20
JournalParkinsonism and Related Disorders
Volume45
DOIs
Publication statusPublished - 1 Dec 2017

Keywords

  • Levodopa-carbidopa intestinal gel
  • Motor symptoms
  • Non-motor symptoms
  • Parkinson's disease
  • Routine patient care

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    Antonini, A., Poewe, W., Chaudhuri, K. R., Jech, R., Pickut, B., Pirtošek, Z., Szasz, J., Valldeoriola, F., Winkler, C., Bergmann, L., Yegin, A., Onuk, K., Barch, D., Odin, P., Amalia, E., Arnold, G., Bajenaru, O., Bergmans, B., Bjornara, K. A., ... Van Zandijcke, M. (2017). Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry. Parkinsonism and Related Disorders, 45, 13-20. https://doi.org/10.1016/j.parkreldis.2017.09.018