Retrospective chart review of the uncontrolled, open-label pre-dinner administration of elobixibat in Japanese adults with chronic constipation

Abstract Background Elobixibat has been approved as a new therapeutic drug for chronic constipation. Its pharmacological efficacy and safety profile of pre-breakfast administration of elobixibat alone has been demonstrated. Objectives We evaluated the efficacy and safety profile of pre-dinner administration of elobixibat in patients with functional constipation in a retrospective observational study. Methods The subjects aged 20 years or older were diagnosed with functional constipation by the Rome IV criteria from June 1, 2018 to January 17, 2019. The evaluation time points were at the start and 1, 2, 4, and 8 weeks after treatment. The primary end point was frequency of spontaneous bowel movements (SBM) per week. The secondary endpoints were changes in Bristol Stool Form Scale (BSFS) score, onset time required for spontaneous defecation after administration, ratio of patients with spontaneous defecation within 24 hours and 48 hours after the first administration, improvement of abdominal pain or abdominal bloating evaluated by the visual analogue scale, and total score and each sub-score of the Japanese-Translated Version of Patient Assessment of Constipation Quality of Life Questionnaire (JPAC-QOL). Results Pre-dinner administration of elobixibat was associated with significantly increased frequency of SBM and improves BSFS score at 1, 2, 4, and 8 weeks after treatment. The mean onset time until spontaneous defecation after treatment was 4 to 5 hours in the population, which was earlier than that by conventional constipation treatment drugs and almost constant within the individual during the treatment period. Ratio of spontaneous defecation were 85.4% within 24 hours and 90.2% within 48 hours after the first administration. Elobixibat also improved patients’ QOL evaluated by JPAC-QOL without adverse events. Conclusion Pre-dinner administration of elobixibat improved constipation, abdominal pain and bloating, and patient's QOL by a management of fixed defecation.