Background: Levodopa-carbidopa intestinal gel (LCIG) is an established treatment for improving motor and some non-motor symptoms (NMS) in patients with advanced Parkinson's disease (PD). Prospective long-term data in routine clinical practice are limited. Objective: Assess LCIG effectiveness and safety in patients with advanced PD after 12 months during real-world routine clinical practice. Methods: Duodopa/Duopa in patients with advanced Parkinson's disease—a global observational study evaluating 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 are planned. The primary outcome is the change in patient-reported off time. Other assessments include the Unified 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 serious adverse events (SAEs). Outcomes from baseline to month (M) 12 are presented. Results: 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 in off time (−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 and sleepiness 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. Conclusions: 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.

DUOGLOBE. One-Year Outcomes in a Real-World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease / Standaert DG, Anca-Herschkovitsch M; Bourgeois P., Cubo E; Davis, Tl; Iansek, R; Kovács, N; Pontieri, Fe; Siddiqui, Ms; Simu, M; Bergmann, L; ., Kukreja PI; Robieson, Wzi; Chaudhuri, Kr. - In: MOVEMENT DISORDERS CLINICAL PRACTICE. - ISSN 2330-1619. - 8:7(2021), pp. 1061-1074. [10.1002/mdc3.13239]

DUOGLOBE. One-Year Outcomes in a Real-World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease

Pontieri FE;
2021

Abstract

Background: Levodopa-carbidopa intestinal gel (LCIG) is an established treatment for improving motor and some non-motor symptoms (NMS) in patients with advanced Parkinson's disease (PD). Prospective long-term data in routine clinical practice are limited. Objective: Assess LCIG effectiveness and safety in patients with advanced PD after 12 months during real-world routine clinical practice. Methods: Duodopa/Duopa in patients with advanced Parkinson's disease—a global observational study evaluating 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 are planned. The primary outcome is the change in patient-reported off time. Other assessments include the Unified 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 serious adverse events (SAEs). Outcomes from baseline to month (M) 12 are presented. Results: 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 in off time (−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 and sleepiness 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. Conclusions: 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.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1577234
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