Alimentary pharmacology & therapeutics
July 1, 2026 · via Europe PMC
Elobixibat Versus Prucalopride in Functional Constipation: A Prospective Comparative Effectiveness Study.
Goyal O, Goyal MK, Singh B, Singh R, Goyal P, Mehta V, Kaushal S, Sood A.
AI summary — for doctors, generated from the abstract only
In a prospective pragmatic study of 214 patients with refractory functional constipation, elobixibat produced a higher sustained bowel movement response than prucalopride over 8 weeks.
What was studied
A multicenter, prospective, pragmatic comparative effectiveness study with blinded outcome assessment in Indian adults with Rome IV functional constipation refractory to first-line therapy, treated with elobixibat (n=108) or prucalopride (n=106) for 8 weeks.
Key findings
- Sustained complete spontaneous bowel movement response: 55.6% with elobixibat vs 33.9% with prucalopride (P = 0.024)
- Both treatments improved bowel movement frequency and stool consistency
- Elobixibat showed greater improvement in symptoms such as straining (specific statistic not fully captured in the abstract)
- Quality-of-life benefit favored elobixibat according to the authors
Clinical relevance
The results suggest elobixibat may be a reasonable second-line option to consider, but the pragmatic design and unclear allocation method limit certainty compared with a blinded RCT.
Who should care
Limitations
Allocation method is not described as randomized in the abstract; 8-week duration and truncated secondary results.
Elobixibat outperformed prucalopride for hard-to-treat constipation in this head-to-head study.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Background and aims
The choice of second-line therapy in functional constipation (FC) is often empirical, owing to the lack of direct comparisons between agents with distinct mechanisms of action. Elobixibat, an ileal bile acid transporter inhibitor, and prucalopride, a selective 5-HT4 receptor agonist, represent two different therapeutic approaches targeting intestinal secretion and colonic motility. This study aimed to directly compare the efficacy of elobixibat and prucalopride in patients with FC.
Methods
In this multicentre, prospective, pragmatic study with blinded outcome assessment, adults meeting Rome IV criteria for FC and refractory to first-line treatment were enrolled after a standardized run-in period. Participants received either elobixibat or prucalopride for 8 weeks. The primary endpoint was a sustained complete spontaneous bowel movement (CSBM) response, defined as ≥ 3 CSBMs per week and an increase of ≥ 1 CSBM from baseline for at least 6 of 8 weeks. Secondary outcomes included changes in stool consistency, associated symptoms and quality of life (QoL).
Results
A total of 214 patients were included (elobixibat, n = 108; prucalopride, n = 106), with a mean age of 50.8 ± 17.4 years and 62.6% males. Elobixibat resulted in a significantly higher sustained CSBM response compared to prucalopride (55.6% vs. 33.9%; p = 0.024), indicating a clinically meaningful benefit. Both treatments significantly improved CSBM frequency and stool consistency; however, elobixibat showed greater improvement in key symptom domains, including straining (p < 0.001), abdominal discomfort (p = 0.005), bloating (p = 0.011) and QoL (p = 0.009). Both drugs were well tolerated.
Conclusions
This head-to-head comparative study demonstrates that elobixibat provides superior overall symptomatic relief and quality-of-life improvement compared with prucalopride, potentially due to its dual mechanism of action. These findings support the consideration of IBAT inhibition as a second-line treatment option in patients with FC.
Trial registration
Clinical Trials Registry of India: CTRI/2025/04/085075.
DOI
10.1111/apt.70828
PMID
42387275
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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