オオヤマ　ゲンコウ   OYAMA Genko   大山　彦光    所属   埼玉医科大学  医学部 脳神経内科    職種   教授
論文種別	学術雑誌(原著)
言語種別	英語
査読の有無	査読なし
表題	Efficacy and Safety of Elobixibat in Parkinson's Disease with Chronic Constipation: CONST-PD Study.
掲載誌名	正式名：Movement disorders clinical practice
掲載区分	国外
著者・共著者	Taku Hatano,Genko Oyama,Yasushi Shimo,Kotaro Ogaki,Noriko Nishikawa,Ryota Nakamura,Taiji Tsunemi,Takashi Ogawa,Hiroto Eguchi,Kensuke Daida,Naohide Kurita,Shin-Ichi Ueno,Jiro Fukae,Wataru Sako,Kenta Shiina,Sho Nakajima,Yutaka Oji,Ryo Wakamori,Shinji Saiki,Kenya Nishioka,Ayami Okuzumi,Daisuke Taniguchi,Haruka Takeshige-Amano,Atsuhito Fuse,Asuka Nakajima,Masayoshi Kano,Hikaru Kamo,Yuri Yamashita,Atsuhiko Shindo,Naotake Yanagisawa,Nobutaka Hattori
発行年月	2024/01/24
概要	BACKGROUND: Chronic constipation is a common digestive complication of Parkinson's disease (PD). OBJECTIVES: To verify the usefulness of elobixibat, an ileal bile acid transporter inhibitor, for chronic constipation in PD. METHODS: This double-blind, placebo-controlled study consisted of a 2-week observation/washout period and a 4-week treatment period. All patients received a Bowel Movement Diary at Week -2 and were allocated to elobixibat (10 mg) or placebo at Week 0. Patients visited at Weeks 2 and 4 to report daily spontaneous bowel movements (SBM), stool form, drug use, quality of life (QOL), and safety. Changes in these parameters were assessed. RESULTS: The study included 38 patients in the elobixibat group and 39 in the placebo group, and 37 each completed the study. SBM frequency/week (mean ± standard deviation) increased significantly from 4.2 ± 2.6 at baseline to 5.9 ± 3.2 at Week 4 in the elobixibat group (P = 0.0079), but not in the placebo group (4.5 ± 2.7 to 5.3 ± 3.5; P = 0.0889). On analysis of covariance, the between-group difference in frequency changes at Week 4 (primary endpoint) was not significant after adjustment by baseline and sex (point estimate = 0.8; 95% confidence interval = -0.57 to 2.09, P = 0.2601), although a significant difference (P = 0.0011) was evidenced at Week 1 by a similar analysis. Stool form and scores of satisfaction and stigma were improved by elobixibat. Adverse events were as previously reported. CONCLUSIONS: Elobixibat improved the SBM frequency, though the defined primary endpoint was not evidenced. QOL parameters (stool consistency and treatment satisfaction) were also improved. Elobixibat may have therapeutic benefits in PD patients suffering from chronic constipation. TRIAL REGISTRATION INFORMATION: Trial Registration Number: JPRN-jRCTs031200172 (submitted: October 26, 2020; first patient enrolment: December 23, 2020; https://jrct.niph.go.jp/en-latest-detail/jRCTs031200172).
DOI	10.1002/mdc3.13972
PMID	38264844