RT info:eu-repo/semantics/article
T1 Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results
A1 Chaudhuri, K. Ray
A1 Kovács, Norbert
A1 Pontieri, Francesco E.
A1 Aldred, Jason
A1 Bourgeois, Paul
A1 Davis, Thomas L.
A1 Cubo Delgado, Esther
A1 Anca-Herschkovitsch, Marieta
A1 Iansek, Robert
A1 Siddiqui, Mustafa S.
A1 Simu, Mihaela
A1 Bergmann, Lars
A1 Ballina, Mayra
A1 Kukreja, Pavnit
A1 Ladhani, Omar
A1 Jia, Jia
A1 Standaert, David G.
K1 DUOGLOBE
K1 Parkinson’s disease
K1 Levodopa-carbidopa intestinal gel
K1 Dyskinesia
K1 Real-world data
K1 Sistema nervioso-Enfermedades
K1 Nervous system-Diseases
K1 Medicina
K1 Medicine
K1 Neurología
K1 Neurology
AB Background:Levodopa-carbidopa intestinal gel (LCIG) improves motor and non-motor symptoms in patients with advanced Parkinson’s disease (aPD).Objective:To present the final 36-month efficacy and safety results from DUOGLOBE (DUOdopa/Duopa in Patients with Advanced Parkinson’s Disease – a GLobal OBservational Study Evaluating Long-Term Effectiveness; NCT02611713).Methods:DUOGLOBE was an international, prospective, long-term, real-world, observational study of patients with aPD initiating LCIG in routine clinical care. The primary endpoint was change in patient-reported “Off” time to Month 36. Safety was assessed by monitoring serious adverse events (SAEs).Results:Significant improvements in “Off” time were maintained over 3 years (mean [SD]: –3.3 hours [3.7]; p < 0.001). There were significant improvements to Month 36 in total scores of the Unified Dyskinesia Rating Scale (–5.9 [23.7]; p = 0.044), Non-Motor Symptoms Scale (–14.3 [40.5]; p = 0.002), Parkinson’s Disease Sleep Scale-2 (–5.8 [12.9]; p < 0.001), and Epworth Sleepiness Scale (–1.8 [6.0]; p = 0.008). Health-related quality of life and caregiver burden significantly improved through Months 24 and 30, respectively (Month 24, 8-item Parkinson’s Disease Questionnaire Summary Index, –6.0 [22.5]; p = 0.006; Month 30, Modified Caregiver Strain Index, –2.3 [7.6]; p = 0.026). Safety was consistent with the well-established LCIG profile (SAEs: 54.9% of patients; discontinuations: 54.4%; discontinuations due to an adverse event: 27.2%). Of 106 study discontinuations, 32 patients (30.2%) continued LCIG outside the study.Conclusion:DUOGLOBE demonstrates real-world, long-term, reductions in motor and non-motor symptoms in patients with aPD treated with LCIG.
PB IOS Press
SN 1877-7171
YR 2023
FD 2023-07
LK http://hdl.handle.net/10259/8834
UL http://hdl.handle.net/10259/8834
LA eng
DS Repositorio Institucional de la Universidad de Burgos
RD 09-may-2024