J Neurogastroenterol Motil.  2022 Jul;28(3):431-441. 10.5056/jnm20263.

Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance

• Nakajima A
• Fujimaki M
• Arai Y
• Emori K

• KMID: 2531217
• DOI: http://doi.org/10.5056/jnm20263

Abstract

Background/Aims
Elobixibat, an ileal bile acid transporter (apical sodium-dependent bile acid transporter) inhibitor, was recently launched in Japan for the treatment of chronic idiopathic constipation. We conducted an interim analysis of post-marketing surveillance to evaluate the safety and efficacy of elobixibat in elderly patients with chronic constipation and compared the efficacy according to administration time.
Methods
Safety and efficacy outcomes were evaluated through patient interviews for 4 weeks.
Results
Adverse drug reactions (ADRs) were observed in 5.24% of the 1049 patients analyzed; diarrhea (2.19%) and abdominal pain (1.81%) were the most common. A serious ADR of death was reported in one patient (0.10%). The incidence of ADRs in the ≥ 65-year old or ≥ 75-year-old subpopulation was similar to that in the total patient population. Mean bowel movements per week significantly increased from 2.9 ± 2.5 at baseline to 5.0 ± 3.1 (P< 0.001) at Week 2 and 5.3 ± 2.6 (P < 0.001) at Week 4. The mean Bristol Stool Form Scale score significantly increased from 2.3 ± 1.4 at baseline to 3.8 ± 1.3 (P < 0.001) at Week 2 and 3.9 ± 1.1 at Week 4 (P < 0.001). Bowel movements significantly increased in the elderly population and subpopulations receiving elobixibat before breakfast, lunch, or dinner. The median time to bowel movement was 5 hours.
Conclusion
The results suggested that elobixibat was well-tolerated and efficacious in elderly patients with chronic constipation and can be administered before any meals.

Keyword

Bile acids; Constipation; Elobixibat; Product surveillance; postmarketing