2026-06-19T17:25:09Zhttps://riubu.ubu.es/oai/requestoai:riubu.ubu.es:10259/88122024-03-14T11:52:33Zcom_10259_4219com_10259_5086com_10259_2604col_10259_4220
Repositorio Institucional de la Universidad de Burgos
author
Standaert, David G.
author
Aldred, Jason
author
Anca-Herschkovitsch, Marieta
author
Bourgeois, Paul
author
Cubo Delgado, Esther
author
Davis, Thomas L.
author
Iansek, Robert
author
Kovács, Norbert
author
Pontieri, Francesco E.
author
Siddiqui, Mustafa S.
author
Simu, Mihaela
author
Bergmann, Lars
author
Kukreja, Pavnit
author
Robieson, Weining
author
Chaudhuri, K. Ray
2024-03-12T13:20:52Z
2024-03-12T13:20:52Z
2021-05
2330-1619
http://hdl.handle.net/10259/8812
10.1002/mdc3.13239
2330-1619
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.
eng
Attribution-NonCommercial-NoDerivatives 4.0 Internacional
DUOGLOBE
Parkinson’s disease
Levodopa-carbidopa intestinal gel
Dyskinesia
Real-world data
DUOGLOBE: One‐Year Outcomes in a Real‐World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease
info:eu-repo/semantics/article
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URL
https://riubu.ubu.es/bitstream/10259/8812/1/Standaert-mdcp_2021.pdf
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Standaert-mdcp_2021.pdf