Masahito Mihara    Department   Kawasaki Medical School  Kawasaki Medical School, Department of Neurology,    Position   Professor
Article types	原著
Language	English
Peer review	Peer reviewed
Title	Efficacy and safety of levodopa-carbidopa intestinal gel from a study in Japanese, Taiwanese, and Korean advanced Parkinson's disease patients.
Journal	Formal name：NPJ Parkinson's disease Abbreviation：NPJ Parkinsons Dis ISSN code：23738057/23738057
Domestic / Foregin	Foregin
Volume, Issue, Page	2,pp.16020
Author and coauthor	Murata Miho, Mihara Masahito, Hasegawa Kazuko, Jeon Beomseok, Tsai Chon-Haw, Nishikawa Noriko, Oeda Tomoko, Yokoyama Masayuki, Robieson Weining Z, Ryman Davis, Eaton Susan, Chatamra Krai, Benesh Janet
Publication date	2016
Summary	In a previous multinational, randomized, double-blind, double-dummy study, levodopa-carbidopa intestinal gel (LCIG) was tolerable and significantly improved 'off' time in advanced Parkinson's disease (PD) patients. However, efficacy and safety in the Asian population has not yet been demonstrated. In this open-label study, efficacy and safety of LCIG were assessed in Japanese, Korean, and Taiwanese advanced PD patients with motor complications not adequately controlled by available PD medication. The patients were treated with LCIG monotherapy for 12 weeks. The primary end point was the mean change from baseline to week 12 in 'off' time, as reported in the PD Symptom Diary, normalized to a 16 h waking day and analyzed by a mixed-model repeated-measures analysis. Adverse events (AEs) were recorded. Thirty-one patients were enrolled (23 Japanese, 4 Taiwanese, 4 Korean) and 28 (90%) completed the study. For those who completed the study, the mean (s.d.) total daily levodopa dose from LCIG was 1,206.3 (493.6) mg/day at final visit (n=28); last observation carried forward (n=30) was 1,227.6 (482.8) mg/day. There was a significant mean change (s.d.) of -4.6 (3.0) hours of 'off' time from baseline (mean (s.d.)=7.4 (2.3)) to week 12 (n=29), P<0.001. All the patients had an AE, with the most frequently reported being incision site pain (42%); 1 (3.2%) discontinued treatment because of an AE and later died because of sepsis, which the investigator considered unrelated to LCIG treatment. These results suggest that LCIG is efficacious and tolerable in Japanese, Taiwanese, and Korean advanced PD patients.
DOI	10.1038/npjparkd.2016.20
PMID	28725701