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	Safety and efficacy of levodopa-carbidopa intestinal gel: results from an open-label extension study in Japanese, Korean and Taiwanese patients with advanced Parkinson's disease.
掲載誌名	正式名：Therapeutic advances in neurological disorders 略　 称：Ther Adv Neurol Disord ISSNコード：17562856/17562856
掲載区分	国外
巻・号・頁	11,pp.1756286418759315
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, Chatamra Krai, Facheris Maurizio F, Benesh Janet
発行年月	2018/02
概要	Objectives:Levodopa-carbidopa intestinal gel (LCIG) was developed to reduce motor complications in Parkinson's disease (PD) caused by pulsatile levodopa plasma concentrations following oral levodopa administration. Dyskinesia and 'wearing off' symptoms can vary between Asian and Caucasian patients with PD, thus highlighting the importance of assessing the effectiveness of LCIG in an Asian population. Efficacy and safety of LCIG were previously assessed in a 12-week open-label study; we report the efficacy and safety of at least 52 weeks of LCIG treatment in Japanese, Taiwanese, and Korean patients with advanced PD in the ongoing extension study.Methods:In this interim analysis of a phase III, open-label, multicenter extension study in Japan, South Korea, and Taiwan [ClinicalTrials.gov identifier: NCT02082249/JapiCTI-142482], the mean change from baseline to final visit in 'off' time, as reported in the PD symptom diary, was normalized to a 16-h waking day. Changes in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index and domains scores were also analyzed. Adverse events (AEs) were recorded.Results:Of the 28 patients enrolled (21 Japanese, 3 Taiwanese, 4 Korean), 27 completed at least 52 total weeks of treatment, and 25 patients were continuing in the study at data cutoff. The mean [standard deviation (SD)] 'off' time was significantly reduced by 4.6 (3.1) h/day (p < 0.001, n = 28). Patients experienced significant improvements in quality of life, as recorded by the mean change from baseline in PDQ-39 summary index (p < 0.001). All patients had at least one AE; three patients (11%) discontinued due to an AE. There were two deaths (sepsis and drowning), both of which the investigator considered unrelated to LCIG treatment.Conclusions:These data suggest that LCIG treatment is efficacious, safe, and well tolerated in Japanese, Taiwanese, and Korean patients with advanced PD, thus confirming the consistency of LCIG treatment in patients with advanced PD.
DOI	10.1177/1756286418759315
PMID	29511383