• Shin Fukudo, Hiroto Miwa, Atsushi Nakajima, Ken Haruma, Masanori Kosako, Ayako Nakagawa, Hiraku Akiho, Yusuke Yamaguchi, Jeffrey M Johnston, Mark Currie, and Yoshikazu Kinoshita.
• Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
• Neurogastroenterol. Motil. 2018 Dec 1; 30 (12): e13444.

BackgroundClinical 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.MethodsThis 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 ResultsPart 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 InferencesThis study suggests that a linaclotide dose of 0.5 mg is effective and safe for IBS-C patients in Japan.© 2018 The Authors. Neurogastroenterology & Motility Published by John Wiley & Sons Ltd.

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