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<dc:creator>Standaert, David G.</dc:creator>
<dc:creator>Aldred, Jason</dc:creator>
<dc:creator>Anca-Herschkovitsch, Marieta</dc:creator>
<dc:creator>Bourgeois, Paul</dc:creator>
<dc:creator>Cubo Delgado, Esther</dc:creator>
<dc:creator>Davis, Thomas L.</dc:creator>
<dc:creator>Iansek, Robert</dc:creator>
<dc:creator>Kovács, Norbert</dc:creator>
<dc:creator>Pontieri, Francesco E.</dc:creator>
<dc:creator>Siddiqui, Mustafa S.</dc:creator>
<dc:creator>Simu, Mihaela</dc:creator>
<dc:creator>Bergmann, Lars</dc:creator>
<dc:creator>Kukreja, Pavnit</dc:creator>
<dc:creator>Robieson, Weining</dc:creator>
<dc:creator>Chaudhuri, K. Ray</dc:creator>
<dc:date>2021-05</dc:date>
<dc:description>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&lt; 0.001),dyskinesia assessed using the UDysRS ( 9.6 22.5,P&lt; 0.001), NMSS ( 23.1 41.4,P&lt; 0.001), sleep andsleepiness symptoms on the PDSS-2 ( 6.5 12.2,P&lt; 0.001) and ESS ( 1.0 5.7,P&lt; 0.05), HR-QoL ( 9.0 21.6,P&lt; 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.</dc:description>
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<dc:identifier>http://hdl.handle.net/10259/8812</dc:identifier>
<dc:language>eng</dc:language>
<dc:publisher>International Parkinson and Movement Disorder Society</dc:publisher>
<dc:title>DUOGLOBE: One‐Year Outcomes in a Real‐World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease</dc:title>
<dc:type>info:eu-repo/semantics/article</dc:type>
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