A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan

Shin Fukudo, Hiroto Miwa, Atsushi Nakajima, Ken Haruma, Masanori Kosako, Ayako Nakagawa, Hiraku Akiho, Yusuke Yamaguchi, Jeffrey M. Johnston, Mark Currie, Yoshikazu Kinoshita

研究成果: Article査読

23 被引用数 (Scopus)

抄録

Background: Clinical testing was required to verify the effect of linaclotide 0.5 mg/d in patients with irritable bowel syndrome with constipation (IBS-C) in Japan. Methods: This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan. Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks. The primary endpoints were the responder rate of global improvement of IBS symptoms and complete spontaneous bowel movement (CSBM) during 12 weeks. The secondary endpoints included responder rates of SBM and abdominal pain/discomfort relief. Key Results: Part 1: The responder rates for global improvement and for CSBM frequency were significantly higher for linaclotide compared to placebo (P < 0.001). Secondary endpoints including responder rates for SBM and abdominal pain/discomfort relief in the linaclotide group were also significantly greater than those in the placebo group. Part 2: Patients switched from placebo to linaclotide showed similar responder rates for global improvement and CSBM frequency to those in patients who continued to receive linaclotide, supporting sustained efficacy. Diarrhea was seen in 14.5% of patients; all cases were mild or moderate. Conclusions and Inferences: This study suggests that a linaclotide dose of 0.5 mg is effective and safe for IBS-C patients in Japan.

本文言語English
論文番号e13444
ジャーナルNeurogastroenterology and Motility
30
12
DOI
出版ステータスPublished - 2018 12月
外部発表はい

ASJC Scopus subject areas

  • 生理学
  • 内分泌系および自律システム
  • 消化器病学

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