PMID- 35975404
OWN - NLM
STAT- MEDLINE
DCOM- 20221205
LR  - 20230411
IS  - 1365-2982 (Electronic)
IS  - 1350-1925 (Print)
IS  - 1350-1925 (Linking)
VI  - 34
IP  - 12
DP  - 2022 Dec
TI  - Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in 
      women: Results of a randomized, double-blind, placebo-controlled phase 2 trial.
PG  - e14448
LID - 10.1111/nmo.14448 [doi]
LID - e14448
AB  - BACKGROUND: Preclinical and clinical studies suggest that beta(3) -adrenergic 
      receptor activation may be a novel target for treating abdominal pain and 
      gastrointestinal motility dysfunction in patients with irritable bowel syndrome 
      (IBS). This proof-of-concept study evaluated the efficacy and safety of the beta(3) 
      -adrenergic agonist vibegron in treating IBS-related pain. METHODS: Adult women 
      with predominant-diarrhea IBS (IBS-D) or with mixed diarrhea/constipation 
      (IBS-M), diagnosed using Rome IV criteria, were randomized 1:1 to receive 
      once-daily vibegron 75 mg or placebo for 12 weeks. The primary endpoint was the 
      percentage of patients with IBS-D considered abdominal pain intensity (API) 
      weekly responders, defined as >/=30% reduction from baseline at week 12 in mean 
      weekly worst abdominal pain over 24 hours using the API score. Patients completed 
      a pain diary at baseline and at weeks 2, 4, 8, and 12. Safety was assessed by 
      adverse events (AEs) in the overall IBS population. KEY RESULTS: Of the 222 
      patients with IBS randomized (vibegron, N = 111; placebo, N = 111), 85% completed 
      the trial. There was no significant difference in the percentage of patients with 
      IBS-D (vibegron, N = 66; placebo, N = 63) considered API weekly responders with 
      vibegron vs. placebo (p = 0.8222) after 12 weeks. The incidence of AEs was 
      comparable between treatment groups (33.3% each), with equal rates of worsening 
      IBS symptoms (2.7% each). CONCLUSIONS AND INFERENCES: In women with IBS-D, 
      vibegron was not associated with significant improvement in the percentage of API 
      weekly responders. Vibegron was generally safe and well tolerated and, in 
      particular, did not worsen IBS symptoms vs. placebo.
CI  - (c) 2022 The Authors. Neurogastroenterology & Motility published by John Wiley & 
      Sons Ltd.
FAU - Lacy, Brian E
AU  - Lacy BE
AUID- ORCID: 0000-0002-2778-0786
AD  - Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA.
FAU - King, Jennifer
AU  - King J
AD  - Urovant Sciences, Irvine, California, USA.
FAU - Shortino, Denise
AU  - Shortino D
AD  - Urovant Sciences, Irvine, California, USA.
FAU - Schaumburg, Chris
AU  - Schaumburg C
AD  - Urovant Sciences, Irvine, California, USA.
FAU - Haag-Molkenteller, Cornelia
AU  - Haag-Molkenteller C
AD  - Urovant Sciences, Irvine, California, USA.
FAU - Chey, William D
AU  - Chey WD
AD  - Division of Gastroenterology, University of Michigan Health System, Ann Arbor, 
      Michigan, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220816
PL  - England
TA  - Neurogastroenterol Motil
JT  - Neurogastroenterology and motility
JID - 9432572
SB  - IM
MH  - Adult
MH  - Humans
MH  - Female
MH  - *Irritable Bowel Syndrome
MH  - Constipation/drug therapy
MH  - Treatment Outcome
MH  - Diarrhea/chemically induced/drug therapy/complications
MH  - Abdominal Pain/drug therapy/etiology/diagnosis
MH  - Double-Blind Method
PMC - PMC10078113
OTO - NOTNLM
OT  - abdominal pain
OT  - constipation
OT  - diarrhea
OT  - functional colonic diseases
OT  - gastrointestinal diseases
OT  - irritable bowel syndrome
COIS- BE Lacy is a consultant and/or on the scientific advisory boards for Allakos, 
      Alpha Sigma, Arena Pharmaceuticals, Ironwood, Salix, Sanofi, and Viver and serves 
      on the Rome Board of Directors. J King, D Shortino, C Schaumburg, and C 
      Haag-Molkenteller were employees of Urovant Sciences at the time the work was 
      conducted. WD Chey is a consultant for Abbvie, Allakos, Alnylam, Arena, Bayer, 
      Biomerica, Ironwood, Nestle, QOL Medical, Salix/Valeant, Takeda, Urovant 
      Sciences, and Vibrant; has received grant and/or research study funding from 
      Biomerica, Commonwealth Diagnostics International, QOL Medical, and Salix; has 
      stock options in GI on Demand, Modify Health, and Ritter; serves on the Rome 
      Board of Directors; and is a member of the Board of Trustees of the American 
      College of Gastroenterology and Board of Directors of the International 
      Foundation for Gastrointestinal Disorders.
EDAT- 2022/08/18 06:00
MHDA- 2022/12/06 06:00
PMCR- 2023/04/06
CRDT- 2022/08/17 03:02
PHST- 2022/05/20 00:00 [revised]
PHST- 2021/12/16 00:00 [received]
PHST- 2022/07/12 00:00 [accepted]
PHST- 2022/08/18 06:00 [pubmed]
PHST- 2022/12/06 06:00 [medline]
PHST- 2022/08/17 03:02 [entrez]
PHST- 2023/04/06 00:00 [pmc-release]
AID - NMO14448 [pii]
AID - 10.1111/nmo.14448 [doi]
PST - ppublish
SO  - Neurogastroenterol Motil. 2022 Dec;34(12):e14448. doi: 10.1111/nmo.14448. Epub 
      2022 Aug 16.