ミハラ　マサヒト   Masahito Mihara   三原　雅史    所属   川崎医科大学  医学部 臨床医学　神経内科学    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Efficacy and safety of levodopa-carbidopa intestinal gel from a study in Japanese, Taiwanese, and Korean advanced Parkinson's disease patients.
掲載誌名	正式名：NPJ Parkinson's disease 略　 称：NPJ Parkinsons Dis ISSNコード：23738057/23738057
掲載区分	国外
巻・号・頁	2,pp.16020
著者・共著者	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
発行年月	2016
概要	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