Treatment of Chronic Constipation using Elobixibat in a Real-World Setting: A Retrospective Cohort Study using an Electronic Medical Records Database in Japan

Background: Chronic constipation is a common condition affecting people of all ages; therefore, the socioeconomic burden of chronic constipation is nonnegligible. Elobixibat (ELO), an ileal bail acid transport inhibitor, was launched in Japan in 2018. However, evidence of its use in diverse populations is limited.

Objectives: This study aimed to evaluate the prescription of ELO, risk factors associated with ELO discontinuation, and the continuation of stimulants or saline laxatives during ELO treatment in a real-world setting using an extensive electronic medical records database that primarily includes data from acute-care hospitals.

Methods: Data of patients prescribed for ELO from April 1, 2018, to March 31, 2022, were extracted from the database. The discontinuation of ELO and stimulant or saline laxatives during ELO treatment was evaluated using the Kaplan-Meier method. The Cox proportional hazards model evaluated risk factors associated with laxative discontinuation.

Results: In total, 11,062 patients were evaluated. The rate of ELO discontinuation within 360 days of initiation was 78.7%. Hospitalized at the ELO initiation, stage 5 chronic kidney disease, and diagnosis of constipation by departments of obstetrics and gynecology or by departments of malignant neoplasm were identified as risk factors for discontinuation. Diagnosis of constipation, diabetes mellitus, Parkinson's disease, and previous laxative treatment was associated with a lower risk of ELO discontinuation. The prescription rate of stimulants and saline laxatives markedly decreased after ELO initiation; furthermore, nearly half of patients who were continuously prescribed ELO discontinued these laxatives within 360 days.

Conclusions: The discontinuation of ELO was associated with various factors and using ELO may be beneficial in the withdrawal of concurrent stimulants and saline laxatives. These findings may help effectively manage chronic constipation.