Levodopa Carbidopa Intestinal Gel in Advanced Parkinson's Disease: DUOGLOBE Final 3-Year Results.

Autor: Chaudhuri KR; Parkinson's Foundation International Centre of Excellence, King's College Hospital, and King's College Institute of Psychiatry, Biomedical Research Centre, Psychology & Neuroscience, London, United Kingdom., Kovács N; Department of Neurology, University of Pécs, Pécs, Hungary., Pontieri FE; Department of Neuroscience, Mental Health and Sensory Organs, Sapienza University of Rome, Rome, Italy.; Santa Lucia Foundation, IRCCS, Rome, Italy., Aldred J; Selkirk Neurology, Spokane, WA, USA., Bourgeois P; Department of Neurology AZ Groeninge, Kortrijk, Belgium., Davis TL; Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA., Cubo E; Neurology Department, Hospital Universitario Burgos, Burgos, Spain., Anca-Herschkovitsch M; Department of Neurology, Edith Wolfson Medical Center, Holon, Israel., Iansek R; Kingston Centre, Monash Health, Melbourne, Victoria, Australia., Siddiqui MS; Department of Neurology, Wake Forest School of Medicine, Winston Salem, NC, USA., Simu M; Department of Neurology, Victor Babes Universityof Medicine and Pharmacy, Timisoara, Romania., Bergmann L; AbbVie Inc., North Chicago, IL, USA., Ballina M; AbbVie Inc., North Chicago, IL, USA., Kukreja P; AbbVie Inc., North Chicago, IL, USA., Ladhani O; AbbVie Inc., North Chicago, IL, USA., Jia J; AbbVie Inc., North Chicago, IL, USA., Standaert DG; Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.
Jazyk: angličtina
Zdroj: Journal of Parkinson's disease [J Parkinsons Dis] 2023; Vol. 13 (5), pp. 769-783.
DOI: 10.3233/JPD-225105
Abstrakt: Background: Levodopa-carbidopa intestinal gel (LCIG) improves motor and non-motor symptoms in patients with advanced Parkinson's disease (aPD).
Objective: 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).
Methods: 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).
Results: Significant improvements in "Off" time were maintained over 3 years (mean [SD]: -3.3 hours [3.7]; p < 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 < 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.
Conclusion: DUOGLOBE demonstrates real-world, long-term, reductions in motor and non-motor symptoms in patients with aPD treated with LCIG.
Databáze: MEDLINE
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