Effects of Levodopa-Carbidopa Intestinal Gel Compared with Optimized Medical Treatment on Nonmotor Symptoms in Advanced Parkinson’s Disease: INSIGHTS Study

Background. Nonmotor symptoms (NMS) are common in advanced Parkinson’s disease (APD) and reduce health-related quality of life. Objective. The aim of the study was to evaluate levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) on NMS in APD. Methods. INSIGHTS was a pha...

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Published in:Parkinson's disease Vol. 2022; no. 1; p. 1216975
Main Authors: Chung, Sun Ju, Calopa, Matilde, Ceravolo, Maria G., Tambasco, Nicola, Antonini, Angelo, Chaudhuri, K. Ray, Robieson, Weining Z., Sánchez-Soliño, Olga, Zadikoff, Cindy, Jin, Man, Barbato, Luigi M.
Format: Journal Article
Language:English
Published: United States Hindawi 2022
John Wiley & Sons, Inc
Wiley
Subjects:
Carbidopa
Comparative analysis
Dopa
Dopamine
Drug dosages
Dyskinesia
FDA approval
Health aspects
Intestine
Levodopa
Medical research
Medical treatment
Medicine, Experimental
Movement disorders
Neurodegenerative diseases
Parkinson's disease
Patients
Peripheral neuropathy
Quality of life
Sleep
ISSN:2090-8083, 2042-0080
Online Access:Get full text
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Summary:Background. Nonmotor symptoms (NMS) are common in advanced Parkinson’s disease (APD) and reduce health-related quality of life. Objective. The aim of the study was to evaluate levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) on NMS in APD. Methods. INSIGHTS was a phase 3b, open-label, randomized, multicenter study in patients with APD (LCIG or OMT, 26 weeks) (NCT02549092). Primary outcomes assessed were total NMS (NMS scale (NMSS) and PD sleep scale (PDSS-2)). Key secondary outcomes included the Unified PD Rating Scale (UPDRS) Part II, Clinical Global Impression of Change (CGI-C), and PD Questionnaire-8 (PDQ-8). Additional secondary measures of Patient Global Impression of Change (PGIC), King’s PD Pain Scale (KPPS), and Parkinson Anxiety Scale (PAS) also were evaluated. Finally, safety was assessed. Results. Out of 89 patients randomized, 87 were included in the analysis (LCIG, n = 43; OMT, n = 44). There were no significant differences in NMSS or PDSS-2 total score changes (baseline to Week 26) between LCIG and OMT; within-group changes were significant for NMSS (LCIG, p<0.001; OMT, p=0.005) and PDSS-2 (LCIG, p<0.001; OMT, p<0.001). Between-group treatment differences were nominally significant for UPDRS Part II (p=0.006) and CGI-C (p<0.001) at Week 26 in favor of LCIG; however, statistical significance could not be claimed in light of primary efficacy outcomes. PGIC (Week 26) and KPPS (Week 12) scores were nominally significantly reduced with LCIG versus OMT (p<0.001; p<0.05). There were no significant differences in PDQ-8 or PAS. Adverse events (AEs) were mostly mild to moderate; common serious AEs were pneumoperitoneum (n = 2) and stoma-site infection (n = 2) (LCIG). Conclusions. There were no significant differences between LCIG versus OMT in NMSS or PDSS-2; both LCIG and OMT groups significantly improved from baseline. AEs were consistent with the known safety profile.
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Academic Editor: Graziella Madeo
ISSN:2090-8083
2042-0080
DOI:10.1155/2022/1216975