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

Authors


Dr S. Pålhagen, Department of Neurology, Karolinska University Hospital, Huddinge, SE-141 86 Stockholm, Sweden

Tel.: + 46 (0) 8 585 820 59

Fax: + 46 (0) 8 585 870 45

e-mails: sven.palhagen@karolinska.se; sven.palhagen@ki.se

Abstract

Background

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.

Methods

Unified PD rating scale (UPDRS) was the primary efficacy measurement. PD QoL questionnaire 39 (PDQ-39) assessed HRQoL. Subjects were assessed at baseline, ≥3 months after surgery, and then every 3 months.

Results

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 3 months after permanent LCIG) = 43.1 ± 16.7, N = 27, = 0.003; month 12 = 42.5 ± 22.6, n = 25, = 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, = 0.001; 12 months = 28.8 ± 12.8, n = 23, = 0.126.

Conclusions

LCIG provides functional improvement beginning at first visit that is sustained for 12 months.

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