Efficacy and Safety of Elobixibat for Chronic Constipation: a Single-center Prospective Study

<p>Background: Elobixibat is a novel bile acid transporter inhibitor for the treatment of chronic constipation. Its new pharmacological mechanism, which is different from conventional drugs, is expected to become one of the new treatment options.</p><p>Objectives: The aim of this study was to evaluate the efficacy and safety of elobixibat in patients with chronic constipation.</p><p>Methods: This was a prospective study from April 2019 to March 2021 at our hospital. A total of 32 patients (male; 21, mean age; 72.3 years) with symptoms of chronic constipation were enrolled. Among them, 16 patients (50.0%) were aged 75 years or older. Elobixibat 10 mg/day was administered for two weeks, and followed by 10 weeks assigned either 5, 10 or 15 mg/day according to the degree of symptom control. Changes in the Constipation Scoring System (CSS) score and the Bristol Stool Form Scale (BSFS) were measured before and 2, 4 and 12 weeks after elobixibat administration. In addition, LDL cholesterol concentrations were measured before and 4 and 12 weeks after elobixibat administration.</p><p>Results: At 2 weeks, the total CSS score was significantly improved from 11.69±4.51 to 7.56±4.05, and maintained at 4 and 12 weeks. The improvement of score was confirmed in six of eight CSS items, except for abdominal pain and duration of suffering from disturbed defecation. The BSFS was also significantly improved from 2.56±1.71 to 4.47±0.87, and maintained at 4 and 12 weeks nearly close to score of 4, indicating the normal stool form. At 4 weeks, LDL cholesterol concentrations were significantly decreased from 104.5±30.3 mg/dL to 92.2±28.7 mg/dL, and maintained at 12 weeks. Adverse events were observed in 13 of 32 patients (40.6%), and most common events were abdominal pain in nine patients (28.1%) and diarrhea in seven patients (21.9%).</p><p>Conclusion: Our findings suggest that elobixibat may be a useful treatment option in the elderly and male patients with chronic constipation.</p>