Clinical trial: lubiprostone in patients with constipation‐associated irritable bowel syndrome – results of two randomized, placebo‐controlled studies
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Summary: Background Effective treatments for irritable bowel syndrome with constipation (IBS‐C) are lacking. Aim To assess the efficacy and safety of lubiprostone in IBS‐C. Methods A combined analysis was performed among 1171 patients with a Rome II diagnosis of IBS‐C in two phase‐3 randomized trials of lubiprostone 8 mcg vs. placebo twice daily for 12 weeks. Using a balanced seven‐point Likert scale ranging from significantly relieved (+3), to significantly worse (−3), patients responded on their electronic diary to the question: ‘How would you rate your relief of IBS symptoms over the past week compared to how you felt before you entered the study?’. The primary efficacy endpoint was the percentage of overall responders. Results Using an intent‐to‐treat analysis with last observation carried forward, a significantly higher percentage of lubiprostone‐treated patients were considered overall responders compared with those treated with placebo (17.9% vs. 10.1%, P = 0.001). Patients treated with lubiprostone reported a similar incidence of adverse events to those treated with placebo. Conclusions The percentage of overall responders based on patient‐rated assessments of IBS‐C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.
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Placebo-controlled trials have demonstrated efficacy of intestinal secretagogues (lubiprostone, linaclotide, plecanatide, tenapanor) in IBS-C.
“Placebo-controlled trials have demonstrated efficacy of these drugs in IBS-C”
From Irritable bowel syndrome (2020) · cites this paper as [114]
The Abstract and Discussion report that two placebo-controlled phase-3 trials found lubiprostone effective for IBS-C. The cited paper does not establish efficacy for linaclotide, plecanatide, or tenapanor; page numbers were not supplied in our copy. (LLM, conf=0.88)
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- Authors
- DROSSMAN, D. A., CHEY, W. D., JOHANSON, J. F., FASS, R., SCOTT, C., PANAS, R., & UENO, R.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Michigan Medicine (US)
- University of Illinois Chicago, Rockford campus (US)
- University of Arizona (US)
- Corresponding author
- DROSSMAN, D. A.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2008-12-22
- Volume
- 29
- Issue
- 3
- Pages
- 329-341
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2088344246
- Cited by
- 399
- References
- 26
- Citations by year
- 2026: 8 · 2025: 16 · 2024: 15 · 2023: 13 · 2022: 18 · 2021: 26 · 2020: 26 · 2019: 17 · 2018: 21 · 2017: 23 · 2016: 30 · 2015: 25 · 2014: 35 · 2013: 26 · 2012: 34
- FWCI
- 21.34
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Deep Blue (University of Michigan) (submittedVersion)
- Funders
- Takeda Pharmaceuticals North America
- Sucampo Pharmaceuticals
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Health Sciences › Medicine › Epidemiology › Microscopic Colitis
- Keywords
- lubiprostone, irritable bowel syndrome with constipation, prokinetic agents, symptom relief, drug safety
- MeSH terms
- Lubiprostone, Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Alprostadil, Constipation, Defecation, Female, Follow-Up Studies, Gastrointestinal Agents, Humans, Male, Middle Aged, Quality of Life, Rome, Severity of Illness Index, Treatment Outcome, Patient Satisfaction, Irritable Bowel Syndrome, Young Adult
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