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Interim analysis of long‐term intraduodenal levodopa infusion in advanced P arkinson disease
Author(s) -
Pålhagen S. E.,
Dizdar N.,
Hauge T.,
Holmberg B.,
Jansson R.,
Linder J.,
Nyholm D.,
Sydow O.,
Wainwright M.,
Widner H.,
Johansson A.
Publication year - 2012
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/j.1600-0404.2012.01689.x
Subject(s) - medicine , parkinson's disease , levodopa , quality of life (healthcare) , physical therapy , rating scale , observational study , interim analysis , clinical trial , disease , psychology , developmental psychology , nursing
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, 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; 12 months = 28.8 ± 12.8, n = 23, P = 0.126. Conclusions LCIG provides functional improvement beginning at first visit that is sustained for 12 months.