Levodopa-carbidopa intestinal gel in advanced Parkinson's : Final results of the GLORIA registry
Antonini, Angelo (University of Padua)
Poewe, Werner (Medical University of Innsbruck)
Chaudhuri, K.Ray (King's College and King's College Hospital)
Jech, Robert (General University Hospital in Prague)
Pickut, Barbara (Michigan State University)
Pirtošek, Zvezdan (University Medical Center Ljubljana)
Szasz, Jozsef (University of Medicine and Pharmacy Tirgu-Mures)
Valldeoriola, Francesc (Hospital Clínic i Provincial de Barcelona)
Winkler, Christian (Lindenbrunn Hospital)
Bergmann, Lars (AbbVie Inc.)
Yegin, Ashley (AbbVie Inc.)
Onuk, Koray (AbbVie Inc.)
Barch, David (AbbVie Inc.)
Odin, Per (Lund University)
Amalia, Ene (University Emergency Hospital)
Arnold, Guy (Sindelfingen Hospital)
Bajenaru, Ovidiu (University of Medicine and Pharmacy "Carol Davila")
Bergmans, Bruno (AZ St-Jan Brugge-Oostende AV)
Bjornara, Kari Anne (Drammen Hospital)
Blackie, Jeff (John Hunter Hospital)
Bode, Matthias (Odense University Hospital (Dinamarca))
Bourgeois, Paul (Department of Neurology AZ Groeninge)
Bohlhalter, Stephan (Neurology and Neurorehabilitation Center)
Buraga, Ioan (Colentina Hospital)
Burkhard, Pierre R. (Geneva University Hospitals)
Busson, Philippe (Centre Hospitalier Avranches Granvilles)
Calopa, Matilde (Hospital Universitari de Bellvitge)
Clausen, Jesper (Rigshospitalet/Glostup)
Danielsen, Erik Hvid (Aarhus University Hospital (Aarhus, Dinamarca))
Defebvre, Luc (Université of Lille)
Delvaux, Valerie (University of Liege)
Dethy, Sophie (Chu-Tivoli)
Dietrichs, Espen (University of Oslo)
Fàbregues-Boixar i Nebot, Oriol de (Hospital Universitari Vall d'Hebron)
Gerhard, Ransmayr (Kepler University Hospital)
Gusmaroli, Graziano (Ospedale degli Infermi di Biella)
Hahn, Kirsten
Hauptmann, Björn (Neurologisches Zentrum)
Henriksen, Tove (University Hospital of Bispebjerg)
Hernández-Vara, Jorge (Hospital Universitari Vall d'Hebron)
Jeanjean, A. (Université catholique de Louvain)
Kaiserova, Michaela (Palacky University)
Kassubek, Jan (University of Ulm)
Kimber, Thomas (University of Adelaide)
Konitsiotis, Spyridon (University of Ioannina)
Krüger, Rejko (University of Tübingen)
Kulisevsky, Jaime (Institut d'Investigació Biomèdica Sant Pau)
Leenders, Jo (Sint-Dimpa Ziekenhuis)
Lundqvist, Christofer (Akershus University Hospital)
Ory Magne, F. (Toulouse University Hospital)
Marano, Pietro (Nuova Casa di Cura D'Anna)
Milanov, Ivan (University Neurological Hospital "St. Naum")
Modugno, Nicola (IRCCS Neuromed)
Misbahuddin, Anjum (Essex Centre for Neurological Sciences)
Nevrly, Martin (University Hospital and Faculty of Medicine and Dentistry of Palacky University)
Panayiotis, Zikos (251 Hellenic Air Force Hospital)
Pedersen, Kenn Freddy (Stavanger University Hospital)
Pedersen, Stephen W. (Glostrup Hospital University of Copenhagen)
Perju-Dumbrava, Lacramioara (University of Medicine and Pharmacy "Iuliu Hatieganu")
Ponsen, M.M. (Meander Medical Center)
Popescu, Bogdan O. (Carol Davila University of Medicine and Pharmacy)
Rijntjes, Michel (University Clinic Freiburg)
Puente, V. (Institut Hospital del Mar d'Investigacions Mèdiques)
Redecker, Christoph (Jena University Hospital (Alemania))
Schrader, Christoph (Hannover Medical School)
Sensi, Mariachiara (Arcispedale S.Anna)
Simu, Michaela (UMF"Victor Babes")
Spanaki, Cleanthe (University of Crete)
Storch, Alexander (University of Rostock)
Storstein, Anette (Haukeland University Hospital (Bergen, Noruega))
Tomantschger, Volker (Gailtal-Klinik Hermagor)
van der Linden, Chris (St. Lucas Hospital Ghent)
van Laar, T. (University Medical Center Groningen)
Viallet, F. (CH du pays d'Aix)
Witjas, Tatiana (University Hospital Timone)
Wolz, Martin (Elblandklinikum Meissen)
Zibetti, Maurizio (University of Torino)
Van Zandijcke, Michel (AZ Sint-Jan Brugge)
Universitat Autònoma de Barcelona

Data:	2017
Resum:	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. 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. 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%). 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Levodopa-carbidopa intestinal gel ; Motor symptoms ; Non-motor symptoms ; Parkinson's disease ; Routine patient care
Publicat a:	Parkinsonism and Related Disorders, Vol. 45 (december 2017) , p. 13-20, ISSN 1873-5126

DOI: 10.1016/j.parkreldis.2017.09.018
PMID: 29037498

8 p, 826.6 KB

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