2026-09-21T11:34:14Zhttps://riubu.ubu.es/oai/request

oai:riubu.ubu.es:10259/88342024-03-16T01:05:17Zcom_10259_4219com_10259_5086com_10259_2604col_10259_4220

00925njm 22002777a 4500 dc Chaudhuri, K. Ray author Kovács, Norbert author Pontieri, Francesco E. author Aldred, Jason author Bourgeois, Paul author Davis, Thomas L. author Cubo Delgado, Esther author Anca-Herschkovitsch, Marieta author Iansek, Robert author Siddiqui, Mustafa S. author Simu, Mihaela author Bergmann, Lars author Ballina, Mayra author Kukreja, Pavnit author Ladhani, Omar author Jia, Jia author Standaert, David G. author 2023-07 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. 1877-7171 http://hdl.handle.net/10259/8834 10.3233/JPD-225105 1877-718X DUOGLOBE Parkinson’s disease Levodopa-carbidopa intestinal gel Dyskinesia Real-world data Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results