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dc.contributor.authorStandaert, David G.
dc.contributor.authorAldred, Jason
dc.contributor.authorAnca-Herschkovitsch, Marieta
dc.contributor.authorBourgeois, Paul
dc.contributor.authorCubo Delgado, Esther 
dc.contributor.authorDavis, Thomas L.
dc.contributor.authorIansek, Robert
dc.contributor.authorKovács, Norbert
dc.contributor.authorPontieri, Francesco E.
dc.contributor.authorSiddiqui, Mustafa S.
dc.contributor.authorSimu, Mihaela
dc.contributor.authorBergmann, Lars
dc.contributor.authorKukreja, Pavnit
dc.contributor.authorRobieson, Weining
dc.contributor.authorChaudhuri, K. Ray
dc.date.accessioned2024-03-12T13:20:52Z
dc.date.available2024-03-12T13:20:52Z
dc.date.issued2021-05
dc.identifier.issn2330-1619
dc.identifier.urihttp://hdl.handle.net/10259/8812
dc.description.abstractBackground: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.en
dc.format.mimetypeapplication/pdf
dc.language.isoenges
dc.publisherInternational Parkinson and Movement Disorder Societyen
dc.relation.ispartofMovement Disorders Clinical Practice. 2021, V. 8, n. 7, p. 1061-1074en
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectDUOGLOBEen
dc.subjectParkinson’s diseaseen
dc.subjectLevodopa-carbidopa intestinal gelen
dc.subjectDyskinesiaen
dc.subjectReal-world dataen
dc.subject.otherSistema nervioso-Enfermedadeses
dc.subject.otherNervous system-Diseasesen
dc.subject.otherMedicinaes
dc.subject.otherMedicineen
dc.subject.otherNeurologíaes
dc.subject.otherNeurologyen
dc.titleDUOGLOBE: One‐Year Outcomes in a Real‐World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Diseaseen
dc.typeinfo:eu-repo/semantics/articlees
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.relation.publisherversionhttps://doi.org/10.1002/mdc3.13239es
dc.identifier.doi10.1002/mdc3.13239
dc.identifier.essn2330-1619
dc.journal.titleMovement Disorders Clinical Practiceen
dc.volume.number8es
dc.issue.number7es
dc.page.initial1061es
dc.page.final1074es
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersiones


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