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oai:riubu.ubu.es:10259/88122024-03-14T11:52:33Zcom_10259_4219com_10259_5086com_10259_2604col_10259_4220

2024-03-12T13:20:52Z urn:hdl:10259/8812 DUOGLOBE: One‐Year Outcomes in a Real‐World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease Standaert, David G. Aldred, Jason Anca-Herschkovitsch, Marieta Bourgeois, Paul Cubo Delgado, Esther Davis, Thomas L. Iansek, Robert Kovács, Norbert Pontieri, Francesco E. Siddiqui, Mustafa S. Simu, Mihaela Bergmann, Lars Kukreja, Pavnit Robieson, Weining Chaudhuri, K. Ray DUOGLOBE Parkinson’s disease Levodopa-carbidopa intestinal gel Dyskinesia Real-world data Background:Levodopa-carbidopa intestinal gel (LCIG) is an established treatment for improvingmotor and some non-motor symptoms (NMS) in patients with advanced Parkinson’s disease (PD). Prospectivelong-term data in routine clinical practice are limited.ObjectiveObjective:Assess LCIG effectiveness and safety in patients with advanced PD after 12 months during real-worldroutine clinical practice.MethodsMethods:Duodopa/Duopa in patients with advanced Parkinson’s disease—a global observational studyevaluating long-term effectiveness (DUOGLOBE) (NCT02611713) is an ongoing, prospective, multinational,observational study of LCIG-naïve patients treated as part of routine clinical practice; 3 years of follow-up areplanned. The primary outcome is the change in patient-reportedofftime. Other assessments include theUnified Dyskinesia Rating Scale (UDysRS), Non-Motor Symptoms Scale (NMSS), Parkinson’s Disease Sleep scale(PDSS-2), Epworth Sleepiness Scale (ESS), health-related quality of life (HR-QoL), caregiver burden, and seriousadverse events (SAEs). Outcomes from baseline to month (M) 12 are presented.ResultsResults:In this 12-month follow-up, patients (N=195) had baseline characteristics similar to other LCIG studies.Significant improvements (mean change to M12) were observed inofftime ( 3.9 3.6 hr/day,P< 0.001),dyskinesia assessed using the UDysRS ( 9.6 22.5,P< 0.001), NMSS ( 23.1 41.4,P< 0.001), sleep andsleepiness symptoms on the PDSS-2 ( 6.5 12.2,P< 0.001) and ESS ( 1.0 5.7,P< 0.05), HR-QoL ( 9.0 21.6,P< 0.001), and caregiver burden ( 1.9 6.7,P=0.008). Overall, 40.5% (n=79) of patients experienced SAEs;fall (n=6; 3.1%) and urinary tract infection (n=6; 3.1%) were SAEs reported in≥3% of patients.ConclusionsConclusions:These 12-month outcome data show sustained, long-term improvements and support the real-world effectiveness of LCIG in patients with advanced PD. Safety was consistent with previous studies. 2024-03-12T13:20:52Z 2024-03-12T13:20:52Z 2021-05 info:eu-repo/semantics/article 2330-1619 http://hdl.handle.net/10259/8812 10.1002/mdc3.13239 2330-1619 eng Movement Disorders Clinical Practice. 2021, V. 8, n. 7, p. 1061-1074 https://doi.org/10.1002/mdc3.13239 http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess Attribution-NonCommercial-NoDerivatives 4.0 Internacional International Parkinson and Movement Disorder Society