Interim analysis of long-term intraduodenal levodopa infusion in advanced Parkinson disease

Abstract

This interim 12-month analysis is a part of an open-label, observational, prospective study on health outcomes and cost impact of levodopa/carbidopa intestinal gel (LCIG, Duodopa) in Parkinson disease (PD). The specific aim was to investigate clinical and health-related quality of life (HRQoL) effects in routine care. Unified PD rating scale (UPDRS) was the primary efficacy measurement. PD QoL questionnaire 39 (PDQ-39) assessed HRQoL. Subjects were assessed at baseline, ≥3months after surgery, and then every 3months. Twenty-seven treatment-naïve subjects when started with LCIG showed a decrease in UPDRS score that was statistically significant throughout the year: UPDRS total score (mean±SD), baseline=52.1±16.1, N=27, month 0 (first visit; at least 3months after permanent LCIG)=43.1±16.7, N=27, P=0.003; month 12=42.5±22.6, n=25, P=0.017. PDQ-39 results also showed a tendency for improvement: PDQ-39 (mean±SD), baseline=33.6±10.8, N=27, month 0=27.1±11.8, N=27, P=0.001; 12months=28.8±12.8, n=23, P=0.126. LCIG provides functional improvement beginning at first visit that is sustained for 12months.