Trial reportThe American journal of gastroenterology2017
Eluxadoline Efficacy in IBS-D Patients Who Report Prior Loperamide Use.
Trial report in The American journal of gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 52 citations in OpenAlex.
- Efficacy and Safety of the Enterosorbent Silicolgel in Irritable Bowel Syndrome, IBS-D and IBS-M: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial.Neurogastroenterology and motility · 2025Trial
- Trial
- Efficacy and Safety of Eluxadoline in Patients With Irritable Bowel Syndrome With Diarrhea Who Report Inadequate Symptom Control With Loperamide: RELIEF Phase 4 Study.The American journal of gastroenterology · 2019Trial
- Traditional Chinese Medicine Formulae QY305 Reducing Cutaneous Adverse Reaction and Diarrhea by its Nanostructure.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- Current and Future Therapeutic Options for Irritable Bowel Syndrome with Diarrhea and Functional Diarrhea.Digestive diseases and sciences · 2023Review
- Evaluation of the effectiveness and mechanism of action of the Chang-Kang-Fang formula combined with bifid triple viable capsules on diarrhea-predominant irritable bowel syndrome.Frontiers in microbiology · 2023Article
- Functional bowel disorders with diarrhoea: Clinical guidelines of the United European Gastroenterology and European Society for Neurogastroenterology and Motility.United European gastroenterology journal · 2022Review
- Review
- Improved work productivity and health-related quality of life in patients with irritable bowel syndrome with diarrhea receiving eluxadoline following inadequate response to loperamide.Journal of managed care & specialty pharmacy · 2021Article
- Best management of irritable bowel syndrome.Frontline gastroenterology · 2021Review
- Diarrhea-Predominant Irritable Bowel Syndrome: Medical Management Update.Journal of the Canadian Association of Gastroenterology · 2020Article
- Article
- Update on Eluxadoline for the Treatment of Irritable Bowel Syndrome with Diarrhea: Patient Selection and Perspectives.Drug design, development and therapy · 2020Review
- Targeting mu opioid receptors to modulate gastrointestinal function: what have we learnt so far from the studies in functional bowel disorders?F1000Research · 2019Review
- Gut Movements: A Review of the Physiology of Gastrointestinal Transit.Digestive diseases and sciences · 2018Review
- New treatments and therapeutic targets for IBS and other functional bowel disorders.Nature reviews. Gastroenterology & hepatology · 2018Review
- Understanding and Managing IBS and CIC in the Primary Care Setting.Gastroenterology & hepatology · 2018Article
- Existing and emerging therapies for managing constipation and diarrhea.Current opinion in pharmacology · 2017Review
- The place of eluxadoline in the management of irritable bowel syndrome with diarrhea.Therapeutic advances in gastroenterology · 2017Review
- Review
Corrections and comments
- Erratum issued
Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIrritable bowel syndrome with diarrhea (IBS-D) is often managed with over-the-counter therapies such as loperamide, though with limited success. This analysis evaluated the efficacy of eluxadoline in patients previously treated with loperamide in two phase 3 studies.
methodsAdults with IBS-D (Rome III criteria) were enrolled and randomized to placebo or eluxadoline (75 or 100 mg) twice daily for 26 (IBS-3002) or 52 (IBS-3001) weeks. Patients reported loperamide use over the previous year and recorded their rescue loperamide use during the studies. The primary efficacy end point was the proportion of patients with a composite response of simultaneous improvement in abdominal pain and reduction in diarrhea.
resultsA total of 2,428 patients were enrolled; 36.0% reported prior loperamide use, of whom 61.8% reported prior inadequate IBS-D symptom control with loperamide. Among patients with prior loperamide use, a greater proportion treated with eluxadoline (75 and 100 mg) were composite responders vs. those treated with placebo with inadequate prior symptom control, over weeks 1-12 (26.3% (P=0.001) and 27.0% (P<0.001) vs. 12.7%, respectively); similar results were observed over weeks 1-26. When daily rescue loperamide use was imputed as a nonresponse day, the composite responder rate was still higher in patients receiving eluxadoline (75 and 100 mg) vs. placebo over weeks 1-12 (P<0.001) and weeks 1-26 (P<0.001). Adverse events included nausea and abdominal pain.
conclusionsEluxadoline effectively and safely treats IBS-D symptoms of abdominal pain and diarrhea in patients who self-report either adequate or inadequate control of their symptoms with prior loperamide treatment, with comparable efficacy and safety irrespective of the use of loperamide as a rescue medication during eluxadoline treatment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.