RT info:eu-repo/semantics/article
T1 DUOGLOBE: One‐Year Outcomes in a Real‐World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease
A1 Standaert, David G.
A1 Aldred, Jason
A1 Anca-Herschkovitsch, Marieta
A1 Bourgeois, Paul
A1 Cubo Delgado, Esther
A1 Davis, Thomas L.
A1 Iansek, Robert
A1 Kovács, Norbert
A1 Pontieri, Francesco E.
A1 Siddiqui, Mustafa S.
A1 Simu, Mihaela
A1 Bergmann, Lars
A1 Kukreja, Pavnit
A1 Robieson, Weining
A1 Chaudhuri, K. Ray
K1 DUOGLOBE
K1 Parkinson’s disease
K1 Levodopa-carbidopa intestinal gel
K1 Dyskinesia
K1 Real-world data
K1 Sistema nervioso-Enfermedades
K1 Nervous system-Diseases
K1 Medicina
K1 Medicine
K1 Neurología
K1 Neurology
AB 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< 0.001),dyskinesia assessed using the UDysRS ( 9.6 22.5,P< 0.001), NMSS ( 23.1 41.4,P< 0.001), sleep andsleepiness symptoms on the PDSS-2 ( 6.5 12.2,P< 0.001) and ESS ( 1.0 5.7,P< 0.05), HR-QoL ( 9.0 21.6,P< 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.
PB International Parkinson and Movement Disorder Society
SN 2330-1619
YR 2021
FD 2021-05
LK http://hdl.handle.net/10259/8812
UL http://hdl.handle.net/10259/8812
LA eng
DS Repositorio Institucional de la Universidad de Burgos
RD 09-may-2024