Objectives: A retrospective, observational study was conducted to examine the efficacy and safety of elobixibat, a novel therapeutic agent for chronic constipation, in Japanese elderly patients aged ≥ 65 years with chronic constipation.

Methods: The study was conducted at Kunimoto Hospital. Patients who visited the hospital from April 2018 to March 2019 due to symptoms of chronic constipation and who took elobixibat were enrolled. The outcome measures were changes in the Constipation Scoring System (CSS) score and the Bristol stool form scale (BSFS) before and after elobixibat administration.

Results: The study included 150 patients. The total CSS score significantly improved from 11.7±4.5 at baseline to 9.3±5.2 two weeks after drug administration. The improvement was confirmed in six out of eight CSS items. The BSFS at baseline of 2.5±1.8 was improved to 3.4±1.7 two weeks after treatment, nearly close to the normal stool consistency of 4. Adverse reactions were observed in 18 of 150 patients (12.0%) with 21 events, most commonly diarrhea in nine patients (6.0%) and abdominal pain in eight patients (5.3%).

Conclusions: Elobixibat improved not only the frequency of bowel movements but also alleviated various symptoms of constipation, such as difficulty with evacuation and sensations of incomplete evacuation in elderly patients with chronic constipation. All adverse drug reactions were mild in severity with no safety concerns.