Efficacy and Safety of Elobixibat on Constipation in End-Stage Kidney Disease Patients Undergoing Hemodialysis: A Randomized Controlled Trial
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Abstract
Background: Chronic constipation is prevalent among patients with end-stage kidney disease (ESKD). Recently, elobixibat, a novel inhibitor of the ileal bile acid transporter, has been used to treat chronic constipation by stimulating bowel function. However, its efficacy and safety in ESKD patients undergoing hemodialysis (HD) have yet to be examined.
Methods: HD patients diagnosed with chronic constipation, as per the Rome IV criteria, were randomized in a 1:1 allocation ratio to receive either elobixibat or a placebo for 12 weeks. Changes in the Bristol Stool Form Scale (BSFS), frequencies of spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM) per week, LDL cholesterol levels, and the gut microbiota-derived metabolite, P-cresol, from baseline were evaluated after the 12-week period.
Results: A total of 46 patients participated in the study. After 12 weeks of treatment, significant improvements were observed in the BSFS (mean difference [95% confidence interval] = 1.93 [1.37, 2.48], P<0.001), and there was an increase in the frequencies of SBM (2.46 [1.69, 3.23], P<0.001) and CSBM (2.83 [1.63, 3.39], P<0.001) per week in the elobixibat group compared with the placebo group. Additionally, LDL cholesterol levels significantly decreased in the elobixibat group relative to the placebo group (-12.41 [-24.72, -0.09], P<0.001). No significant differences were noted in other laboratory data or P-cresol levels. Furthermore, no serious adverse events were reported in either group.
Conclusion: Elobixibat exhibited an efficacy in improving constipation and reducing LDL cholesterol levels. These findings suggest that elobixibat might be an effective treatment for chronic constipation in ESKD patients undergoing HD.
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