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<dc:title>Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results</dc:title>
<dc:creator>Chaudhuri, K. Ray</dc:creator>
<dc:creator>Kovács, Norbert</dc:creator>
<dc:creator>Pontieri, Francesco E.</dc:creator>
<dc:creator>Aldred, Jason</dc:creator>
<dc:creator>Bourgeois, Paul</dc:creator>
<dc:creator>Davis, Thomas L.</dc:creator>
<dc:creator>Cubo Delgado, Esther</dc:creator>
<dc:creator>Anca-Herschkovitsch, Marieta</dc:creator>
<dc:creator>Iansek, Robert</dc:creator>
<dc:creator>Siddiqui, Mustafa S.</dc:creator>
<dc:creator>Simu, Mihaela</dc:creator>
<dc:creator>Bergmann, Lars</dc:creator>
<dc:creator>Ballina, Mayra</dc:creator>
<dc:creator>Kukreja, Pavnit</dc:creator>
<dc:creator>Ladhani, Omar</dc:creator>
<dc:creator>Jia, Jia</dc:creator>
<dc:creator>Standaert, David G.</dc:creator>
<dc:subject>DUOGLOBE</dc:subject>
<dc:subject>Parkinson’s disease</dc:subject>
<dc:subject>Levodopa-carbidopa intestinal gel</dc:subject>
<dc:subject>Dyskinesia</dc:subject>
<dc:subject>Real-world data</dc:subject>
<dcterms:abstract>Background:&#xd;
Levodopa-carbidopa intestinal gel (LCIG) improves motor and non-motor symptoms in patients with advanced Parkinson’s disease (aPD).&#xd;
&#xd;
Objective:&#xd;
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).&#xd;
&#xd;
Methods:&#xd;
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).&#xd;
&#xd;
Results:&#xd;
Significant improvements in “Off” time were maintained over 3 years (mean [SD]: –3.3 hours [3.7]; p &lt; 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 &lt; 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.&#xd;
&#xd;
Conclusion:&#xd;
DUOGLOBE demonstrates real-world, long-term, reductions in motor and non-motor symptoms in patients with aPD treated with LCIG.</dcterms:abstract>
<dcterms:dateAccepted>2024-03-15T09:40:13Z</dcterms:dateAccepted>
<dcterms:available>2024-03-15T09:40:13Z</dcterms:available>
<dcterms:created>2024-03-15T09:40:13Z</dcterms:created>
<dcterms:issued>2023-07</dcterms:issued>
<dc:type>info:eu-repo/semantics/article</dc:type>
<dc:identifier>1877-7171</dc:identifier>
<dc:identifier>http://hdl.handle.net/10259/8834</dc:identifier>
<dc:identifier>10.3233/JPD-225105</dc:identifier>
<dc:identifier>1877-718X</dc:identifier>
<dc:language>eng</dc:language>
<dc:relation>Journal of Parkinson's Disease. 2023, V. 13, n. 5, p. 769-783</dc:relation>
<dc:relation>https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd225105</dc:relation>
<dc:rights>http://creativecommons.org/licenses/by/4.0/</dc:rights>
<dc:rights>info:eu-repo/semantics/openAccess</dc:rights>
<dc:rights>Atribución 4.0 Internacional</dc:rights>
<dc:publisher>IOS Press</dc:publisher>
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