CHRONIC constipation, which affects a significant proportion of the population, can greatly reduce quality of life and lead to increased healthcare utilisation. A recent study evaluated the short-term efficacy and safety of elobixibat in Indian patients with chronic constipation, focusing on its impact over a two-week treatment period. A key finding of this trial was that elobixibat significantly increased spontaneous bowel movement frequency compared to placebo.
The study was a double-blind, placebo-controlled, phase III trial conducted between April and December 2023. It enrolled patients diagnosed with functional constipation for at least six months, in accordance with Rome IV criteria. After a two-week run-in period to assess baseline bowel movement frequency, participants were randomised in a 1:1 ratio to receive either elobixibat or a placebo. The primary efficacy outcome was the change in the number of weekly spontaneous bowel movements (SBMs) at week two, relative to baseline. Analysis was conducted on the modified intention-to-treat (mITT) population, comprising 146 patients.
Results showed that elobixibat significantly increased weekly SBMs compared to placebo. The least square mean (LSM) for SBM frequency at week two was 3.83 for elobixibat and 2.68 for placebo, yielding a difference of 1.15 (95% CI: 0.31–1.99; p=0.008). Additionally, the proportion of patients achieving a complete spontaneous bowel movement (CSBM) response was higher in the elobixibat group (49.33%) than in the placebo group (26.76%), with a difference of 22.57% (95% CI: 8.36%–36.78%; p=0.005). Adverse events were generally mild, with abdominal pain reported by 7.89% of patients on elobixibat versus 4.05% on placebo.
In conclusion, elobixibat demonstrated both efficacy and tolerability in improving bowel function over a short treatment duration in Indian patients with chronic constipation. While the trial confirms statistically and clinically meaningful benefits, limitations include the short follow-up period and relatively small sample size. Nonetheless, these findings support elobixibat as a valuable therapeutic option in clinical practice for managing chronic constipation in similar patient populations.
Reference
Agarwal P et al. Efficacy and safety of elobixibat in patients with chronic constipation-A randomized, multicenter, double-blind, placebo-controlled, parallel-group study from India. Indian J Gastroenterol. 2025;44(3):336-44
