1. Levodopa-carbidopa intestinal gel in advanced Parkinson's: Final results of the GLORIA registry
- Author
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Lacramioara Perju-Dumbrava, Lars Bergmann, Anjum Misbahuddin, Francesc Valldeoriola, Stephen Wørlich Pedersen, Chris van der Linden, Stephan Bohlhalter, Erik H. Danielsen, David, Maurizio Zibetti, Björn Hauptmann, Oriol De Fabregues, Ashley Yegin, Martin Nevrly, K. Ray Chaudhuri, Jeff Blackie, M.M. Ponsen, Christoph Redecker, Anne Jeanjean, Kenn Freddy Pedersen, Jan Kassubek, Mihaela Simu, Philippe Busson, Barbara A. Pickut, Pierre R. Burkhard, József Attila Szász, Per Odin, Bogdan Ovidiu Popescu, Ene Amalia, Angelo Antonini, Robert Jech, Thomas E. Kimber, Matthias Bode, Kari Anne Bjørnarå, Ivan Milanov, Bruno Bergmans, Espen Dietrichs, Luc Defebvre, Christofer Lundqvist, Jesper Clausen, Michaela Kaiserová, Valérie Delvaux, Werner Poewe, Martin Wolz, Sophie Dethy, Jaime Kulisevsky, Cleanthe Spanaki, Anette Storstein, Michel Rijntjes, F. Ory Magne, Pietro Marano, T. van Laar, Tove Henriksen, Christian Winkler, Ovidiu Bajenaru, Spyridon Konitsiotis, Michel Van Zandijcke, Ransmayr Gerhard, F. Viallet, Koray Onuk, Guy Arnold, Kirsten Hahn, Jo Leenders, Mariachiara Sensi, Jorge Hernández-Vara, Zikos Panayiotis, Nicola Modugno, Volker Tomantschger, Matilde Calopa, Zvezdan Pirtošek, Paul Bourgeois, Graziano Gusmaroli, Christoph Schrader, Ioan Buraga, Víctor Puente, Rejko Krüger, Alexander Storch, Tatiana Witjas, UCL - SSS/IONS/NEUR - Clinical Neuroscience, UCL - (SLuc) Service de neurologie, GLORIA study co-investigators, and Movement Disorder (MD)
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0301 basic medicine ,Male ,Parkinson's disease ,Neurology ,Routine patient care ,Levodopa-carbidopa intestinal gel ,Motor symptoms ,Non-motor symptoms ,Antiparkinson Agents ,Levodopa ,0302 clinical medicine ,Quality of life ,Gériatrie - gérontologie ,Medicine ,Registries ,Parkinson Disease/drug therapy ,Intubation, Gastrointestinal ,Carbidopa/administration & dosage ,Carbidopa ,Parkinson Disease ,Middle Aged ,Safety profile ,Drug Combinations ,Female ,medicine.symptom ,Gastrointestinal ,medicine.medical_specialty ,Levodopa/administration & dosage ,03 medical and health sciences ,Rating scale ,Internal medicine ,Neurologie ,Antiparkinson Agents/administration & dosage ,Humans ,Aged ,business.industry ,medicine.disease ,nervous system diseases ,ddc:616.8 ,030104 developmental biology ,Mood ,Dyskinesia ,Levodopa carbidopa ,Physical therapy ,Geriatrics and Gerontology ,Neurology (clinical) ,Human medicine ,Intubation ,business ,Gels ,030217 neurology & neurosurgery - Abstract
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., 0, SCOPUS: ar.j, info:eu-repo/semantics/published
- Published
- 2017
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