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<field name="value">Chaudhuri, K. Ray</field>
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<field name="value">Standaert, David G.</field>
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<field name="value">2024-03-15T09:40:13Z</field>
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<field name="value">2023-07</field>
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<field name="value">10.3233/JPD-225105</field>
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<field name="value">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.</field>
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<field name="value">Journal of Parkinson's Disease. 2023, V. 13, n. 5, p. 769-783</field>
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<field name="value">Levodopa Carbidopa Intestinal Gel in Advanced Parkinson’s Disease: DUOGLOBE Final 3-Year Results</field>
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