Efficacy and safety of long-term treatment with elobixibat in hemodialysis patients with chronic constipation: an observational study

Abstract

Abstract Background Constipation is a common complication in hemodialysis patients and can impact their quality of life. Elobixibat selectively inhibits ileal bile acid transporter to suppress bile acid reabsorption, increase the amount of bile acid entering the colonic lumen, and promote water secretion and colonic motility in the large intestine. While the efficacy and safety of elobixibat in hemodialysis patients up to 12 weeks after administration have been reported, the long-term efficacy and safety of elobixibat in hemodialysis patients with chronic constipation are yet to be elucidated. This study evaluates the efficacy and safety of long-term treatment with elobixibat in hemodialysis patients with chronic constipation. Methods This was a single-center observational study. A total of 54 patients who had received elobixibat for at least 24 weeks were enrolled. Data on the frequency of spontaneous bowel movements (SBM), Bristol stool form scale (BSFS), patient satisfaction, constipation scoring system (CSS), interdialytic weight gain, laboratory values including blood electrolyte levels, controlling nutritional status (CONUT) score, and adverse events were collected and retrospectively compared between baseline and the last observation. Results Long-term elobixibat treatment in the 54 hemodialysis patients with chronic constipation significantly increased (p < 0.05) the frequency of SBM and mean stool form score assessed as per the BSFS at the last observation (duration of treatment, 24.4 to 240.0 weeks). Patient satisfaction and CSS also improved (p < 0.05). Mean serum phosphorus levels decreased (p < 0.05). The treatment was well tolerated. Conclusions Long-term treatment with elobixibat maintained good bowel movement status and patient satisfaction in hemodialysis patients with chronic constipation. Improved dialysis-related laboratory levels were also demonstrated. Trial registration: UMIN Clinical Trials Registry, UMIN000049865, 22 December 2022, retrospectively registered.