Efficacy, long-term safety, and impact on quality of life of elobixibat in more severe constipation: Post hoc analyses of two phase 3 trials in Japan

Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society
Atsushi NakajimaMichael Camilleri

Abstract

In two phase 3 trials, elobixibat, a locally acting ileal bile acid transporter inhibitor, resolved constipation and was well tolerated in Japanese patients with chronic constipation. We analyzed the efficacy, safety, and impact on quality of life (QOL) of elobixibat in patients with symptomatically more severe constipation in the two phase 3 trials. This post hoc analysis of elobixibat treatment outcomes included data from a 2-week, randomized, placebo-controlled, phase 3 trial (10 mg/d), and a 52-week, open-label trial (5-15 mg/d) in subgroups with severe constipation defined as ≤2 spontaneous bowel movements (SBMs) and ≤3 Bristol Stool Form Scale score during the second week of the 2-week run-in period. We also analyzed the rates of abdominal pain, diarrhea, and QOL in subgroups according to sex, presence of constipation-predominant irritable bowel syndrome (IBS-C) and side effects. In patients with severe constipation, there was significant improvement in the 10 mg elobixibat group compared to the placebo group in change in SBMs from baseline at week 1 (primary endpoint) of the 2-week trial. The differences between groups were reduced in patients with more severe constipation. Increasing the dose to 15 mg was effective for ...Continue Reading

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Citations

Aug 29, 2019·American Journal of Physiology. Gastrointestinal and Liver Physiology·Michael Camilleri
Nov 12, 2020·The Journal of Obstetrics and Gynaecology Research·Christine WuThushari I Alahakoon
Feb 5, 2021·Journal of Gastroenterology·Shin FukudoKazuhiko Koike
Oct 10, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Na YangYu-Bo Li
May 1, 2021·Journal of Clinical Medicine·Jakub WłodarczykMarcin Włodarczyk
May 11, 2021·Digestive Endoscopy : Official Journal of the Japan Gastroenterological Endoscopy Society·Daisuke YamaguchiMotohiro Esaki
Oct 14, 2021·Journal of Neurogastroenterology and Motility·Seung Joo KangUNKNOWN Constipation Research Group of the Korean Society of Neurogastroenterology and Motility
Nov 11, 2021·American Journal of Physiology. Gastrointestinal and Liver Physiology·Stephen J KeelySimona E Carbone

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