TOPLINE

In patients with functional constipation who were refractory to first-line therapy, elobixibat offered superior bowel movement response and symptom relief and greater improvements in quality of life than prucalopride.

METHODOLOGY

• Elobixibat increases the delivery of bile acids to the colon and boosts secretion and motility, whereas prucalopride stimulates colonic motility. However, current decision-making regarding the choice of a second-line agent for functional constipation is mostly empirical.
• Researchers conducted a prospective open-label study to compare the effectiveness of elobixibat and prucalopride across tertiary-care academic centers in India between April 2025 and March 2026.
• Eligible patients met the Rome IV criteria for functional constipation and were refractory to first-line treatment. After a 2-week run-in period, patients received either elobixibat 10 mg once daily or prucalopride 2 mg once daily for 8 weeks at their treating physicians’ discretion.
• Patients maintained daily bowel diaries. The primary efficacy outcome was a sustained complete spontaneous bowel movement (CSBM) response, defined as having at least three CSBMs per week and an increase of at least one CSBM from baseline for at least 6 of 8 weeks.
• Secondary efficacy outcomes included changes in stool consistency; symptom severity; and frequency scores for straining, abdominal discomfort, bloating, incomplete evacuation, and quality of life.

TAKEAWAY

• Among a total of 214 eligible patients, 108 received elobixibat (mean age, 51.4 years; 68.5% men) and 106 received prucalopride (mean age, 50.4 years; 56.6% men).
• A higher proportion of elobixibat recipients than prucalopride recipients achieved a sustained CSBM response at 8 weeks (55.6% vs 33.9%; P = .024). More elobixibat recipients had a CSBM within 24 hours (44.8% vs 23.58%), and their median time to the first complete bowel movement was shorter (7 hours 20 minutes vs 13 hours 30 minutes; P < .01 for both).
• At 8 weeks, recipients of elobixibat had a higher mean weekly CSBM frequency than recipients of prucalopride (3.5 vs 2.8; P = .011), with a greater increase in frequency from baseline (2.5 vs 1.8; P = .004).
• Recipients of elobixibat reported greater relief from straining, abdominal discomfort, and bloating and greater improvements in quality of life (P < .05 for all). Adverse events were mostly mild and occurred at similar rates in both groups.

IN PRACTICE

“[The] results reinforce the importance of targeting multiple pathophysiological pathways in a heterogeneous disorder such as FC [functional constipation],” the authors of the study wrote.

“If confirmed in prospective randomized trials, these findings may further support broader adoption of elobixibat worldwide,” Andrea Shin, MD, wrote in an invited editorial.

SOURCE

The study was led by Omesh Goyal of Dayanand Medical College and Hospital in Ludhiana, India, and Manjeet Kumar Goyal of Cleveland Clinic Akron General in Akron, Ohio. It was published online in Alimentary Pharmacology & Therapeutics.

LIMITATIONS

The open-label design may have introduced performance bias. Researchers did not randomize treatment allocation, which could allow residual confounding. The 8-week duration could not assess long-term efficacy or safety.

DISCLOSURES

The authors did not report any source of funding and declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.