2026-06-18T00:47:18Zhttps://riubu.ubu.es/oai/request

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

Chaudhuri, K. Ray Kovács, Norbert Pontieri, Francesco E. Aldred, Jason Bourgeois, Paul Davis, Thomas L. Cubo Delgado, Esther Anca-Herschkovitsch, Marieta Iansek, Robert Siddiqui, Mustafa S. Simu, Mihaela Bergmann, Lars Ballina, Mayra Kukreja, Pavnit Ladhani, Omar Jia, Jia Standaert, David G. DUOGLOBE Parkinson’s disease Levodopa-carbidopa intestinal gel Dyskinesia Real-world data 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. 2024-03-15 2024-03-15 2023-07 info:eu-repo/semantics/article 1877-7171 http://hdl.handle.net/10259/8834 10.3233/JPD-225105 1877-718X eng Journal of Parkinson's Disease. 2023, V. 13, n. 5, p. 769-783 https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd225105 http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Atribución 4.0 Internacional IOS Press