Levodopa Carbidopa Intestinal Gel in Advanced Parkinson's Disease: DUOGLOBE Final 3-Year Results.
J Parkinsons Dis
; 13(5): 769-783, 2023.
Article
em En
| MEDLINE
| ID: mdl-37302039
ABSTRACT
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]; pâ<â0.001). There were significant improvements to Month 36 in total scores of the Unified Dyskinesia Rating Scale (-5.9 [23.7]; pâ=â0.044), Non-Motor Symptoms Scale (-14.3 [40.5]; pâ=â0.002), Parkinson's Disease Sleep Scale-2 (-5.8 [12.9]; pâ<â0.001), and Epworth Sleepiness Scale (-1.8 [6.0]; pâ=â0.008). 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]; pâ=â0.006; Month 30, Modified Caregiver Strain Index, -2.3 [7.6]; pâ=â0.026). 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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Doença de Parkinson
/
Levodopa
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article