PMID- 32184185
OWN - NLM
STAT- MEDLINE
DCOM- 20210818
LR  - 20210818
IS  - 1542-7714 (Electronic)
IS  - 1542-3565 (Linking)
VI  - 19
IP  - 3
DP  - 2021 Mar
TI  - Efficacy and Safety of 5-HT4 Receptor Agonist Minesapride for Irritable Bowel 
      Syndrome with Constipation in a Randomized Controlled Trial.
PG  - 538-546.e8
LID - S1542-3565(20)30329-3 [pii]
LID - 10.1016/j.cgh.2020.03.019 [doi]
AB  - BACKGROUND & AIMS: Treatment options for irritable bowel syndrome with 
      constipation (IBS-C) are limited-new prokinetic drugs are needed. We evaluated 
      the efficacy and safety of minesapride (DSP-6952), a partial agonist with high 
      affinity for 5-HT4 receptors, in patients with IBS-C in Japan. METHODS: We 
      performed a double-blind phase 2 study of 171 patients with Rome III-defined 
      IBS-C at 33 centers in Japan, from December 2012 through August 2013. Patients 
      were randomly assigned to groups given minesapride (1, 4, 12, or 40 mg) or 
      placebo once daily for 4 weeks. The primary outcome was efficacy, defined as 
      improvement in the weekly frequency of complete spontaneous bowel movements 
      (CSBMs), abdominal symptoms, and IBS-C symptoms (according to the Japanese 
      version of the IBS severity index score). For evaluation of safety, adverse 
      events (AEs) were recorded. RESULTS: The least squares mean change from baseline 
      in the weekly frequency of CSBMs was greater in all minesapride groups than in 
      the placebo group at week 4 (40 mg vs placebo, P = .040). The abdominal symptoms 
      score improved in minesapride 40 mg group. The overall IBS severity index score 
      decreased from baseline to week 4 in all treatment groups-especially in the 12 mg 
      and 40 mg groups (P = .048 and <.001 vs placebo, respectively). The proportions 
      of patients with treatment-emergent AEs in the pooled minesapride and placebo 
      groups were 55.0% and 60.0%, respectively. The most common treatment-emergent AE 
      was diarrhea (in 42.9% and 37.1% of patients in the pooled minesapride and 
      placebo groups, respectively). CONCLUSIONS: In a phase 2 trial of patients with 
      IBS-C in Japan, minesapride increased stool frequency (measured by CSBMs), 
      reduced abdominal and overall IBS-C symptoms, and was well tolerated. Japan 
      Pharmaceutical Information Center trial no: JapicCTI-122041.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Fukudo, Shin
AU  - Fukudo S
AD  - Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, 
      Sendai, Japan. Electronic address: sfukudo@med.tohoku.ac.jp.
FAU - Nakamura, Masatoshi
AU  - Nakamura M
AD  - Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.
FAU - Hamatani, Tatsuto
AU  - Hamatani T
AD  - Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.
FAU - Kazumori, Kiyoyasu
AU  - Kazumori K
AD  - Sumitomo Dainippon Pharma Co, Ltd, Osaka, Japan.
FAU - Miwa, Hiroto
AU  - Miwa H
AD  - Division of Gastroenterology, Department of Internal Medicine, Hyogo College of 
      Medicine, Nishinomiya, Japan.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200314
PL  - United States
TA  - Clin Gastroenterol Hepatol
JT  - Clinical gastroenterology and hepatology : the official clinical practice journal 
      of the American Gastroenterological Association
JID - 101160775
RN  - 158165-40-3 (Receptors, Serotonin, 5-HT4)
SB  - IM
MH  - Constipation/drug therapy
MH  - Diarrhea
MH  - Double-Blind Method
MH  - Humans
MH  - *Irritable Bowel Syndrome/complications/drug therapy
MH  - Receptors, Serotonin, 5-HT4
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Drug
OT  - Serotonin Receptors
OT  - Side Effect
OT  - Therapy
EDAT- 2020/03/19 06:00
MHDA- 2021/08/19 06:00
CRDT- 2020/03/19 06:00
PHST- 2020/01/19 00:00 [received]
PHST- 2020/03/02 00:00 [revised]
PHST- 2020/03/08 00:00 [accepted]
PHST- 2020/03/19 06:00 [pubmed]
PHST- 2021/08/19 06:00 [medline]
PHST- 2020/03/19 06:00 [entrez]
AID - S1542-3565(20)30329-3 [pii]
AID - 10.1016/j.cgh.2020.03.019 [doi]
PST - ppublish
SO  - Clin Gastroenterol Hepatol. 2021 Mar;19(3):538-546.e8. doi: 
      10.1016/j.cgh.2020.03.019. Epub 2020 Mar 14.