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

Preclinical and clinical studies suggest that β3‐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 β3‐adrenergic agonist vibegron in treating IBS‐related pain.

[1]  Paul N. Mudd Jr,et al.  Selectivity and Maximum Response of Vibegron and Mirabegron for β3-Adrenergic Receptors , 2022, Current therapeutic research, clinical and experimental.

[2]  D. Staskin,et al.  Once-Daily Vibegron 75 mg for Overactive Bladder: Long-Term Safety and Efficacy From a Double-Blind Extension Study of the International Phase 3 Trial (EMPOWUR). , 2020, The Journal of urology.

[3]  W. Chey,et al.  ACG Clinical Guideline: Management of Irritable Bowel Syndrome. , 2020, The American journal of gastroenterology.

[4]  P. Whorwell,et al.  Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study. , 2020, Gastroenterology.

[5]  D. Staskin,et al.  International Phase III, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. , 2020, The Journal of urology.

[6]  W. Whitehead,et al.  Prevalence of Rome IV Functional Bowel Disorders Among Adults in the United States, Canada, and the United Kingdom. , 2020, Gastroenterology.

[7]  Lin Chang,et al.  FUNCTIONAL BOWEL DISORDERS , 2018, The American Journal of Gastroenterology.

[8]  S. Puli,et al.  Irritable Bowel Syndrome: A Clinical Review. , 2016, Current rheumatology reviews.

[9]  Jacob E. Kurlander,et al.  Irritable bowel syndrome: a clinical review. , 2015, JAMA.

[10]  D. Dumitrascu,et al.  Four years Follow-up of Patients with Irritable Bowel Syndrome , 2015, Romanian journal of internal medicine = Revue roumaine de medecine interne.

[11]  H. Kakizaki,et al.  Relationship between overactive bladder and irritable bowel syndrome: a large-scale internet survey in Japan using the overactive bladder symptom score and Rome III criteria , 2012, BJU international.

[12]  T. Hibi,et al.  High frequency of overlap between functional dyspepsia and overactive bladder , 2012, Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society.

[13]  A. Gnanasakthy,et al.  Urgency as an Endpoint in Irritable Bowel Syndrome , 2011, Gastroenterology research.

[14]  A. Zinsmeister,et al.  Dose-response effect of a beta3-adrenergic receptor agonist, solabegron, on gastrointestinal transit, bowel function, and somatostatin levels in health. , 2008, American journal of physiology. Gastrointestinal and liver physiology.

[15]  G. Sanger,et al.  Demonstration of functional neuronal beta3-adrenoceptors within the enteric nervous system. , 2007, Gastroenterology.

[16]  P. Jhingran,et al.  Validation of Irritable Bowel Syndrome Global Improvement Scale: An Integrated Symptom End Point for Assessing Treatment Efficacy , 2003, Digestive Diseases and Sciences.

[17]  N. Talley Pharmacologic Therapy for the Irritable Bowel Syndrome , 2003, American Journal of Gastroenterology.

[18]  P. Jhingran,et al.  Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome , 2001, American Journal of Gastroenterology.

[19]  F. Ponti,et al.  Functional evidence of atypical β3‐adrenoceptors in the human colon using the β3‐selective adrenoceptor antagonist, SR 59230A , 1996 .

[20]  J M Robins,et al.  Estimation of a common effect parameter from sparse follow-up data. , 1985, Biometrics.

[21]  M. F. Alexander C. Ford MB ChB,et al.  American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome , 2018, The American Journal of Gastroenterology.

[22]  R. Spiller,et al.  Bowel Disorders. , 2016, Gastroenterology.

[23]  F. De Ponti,et al.  Functional evidence of atypical beta 3-adrenoceptors in the human colon using the beta 3-selective adrenoceptor antagonist, SR 59230A. , 1996, British journal of pharmacology.

[24]  P. Wright A virtual congress , 1995 .

[25]  F. Lönnqvist,et al.  Tissue distribution of beta 3-adrenergic receptor mRNA in man. , 1993, The Journal of clinical investigation.