ArticleTherapeutic advances in gastroenterology2018
Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint.
Article in Therapeutic advances in gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01257477 (Research Study to Evaluate LOTRONEX® in Severe IBS-D), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- Improvement of irritable bowel syndrome with glucagon like peptide-1 receptor agonists: a systematic review and meta-analysis.Frontiers in endocrinology · 2025Pooled it
- Friedel-Crafts Addition of 3-Alkylated Indoles to Aldehydes: 2-Hydroxyalkylation Promoted by Trimethylsilyl Trifluoromethanesulfonate.The Journal of organic chemistry · 2026Article
- Leaky Gut Syndrome: Myths and Management.Gastroenterology & hepatology · 2024Article
- Indole-containing pharmaceuticals: targets, pharmacological activities, and SAR studies.RSC medicinal chemistry · 2024Review
- The Role of the Nurse in the Management of Irritable Bowel Syndrome: A Narrative Review.Translational medicine @ UniSa · 2023Review
- Review
- Neurotransmitter Dysfunction in Irritable Bowel Syndrome: Emerging Approaches for Management.Journal of clinical medicine · 2021Review
- How Serotonin Level Fluctuation Affects the Effectiveness of Treatment in Irritable Bowel Syndrome.Cureus · 2020Review
- Ethnic differences in genetic polymorphism associated with irritable bowel syndrome.World journal of gastroenterology · 2020Review
- Importance of Non-pharmacological Approaches for Treating Irritable Bowel Syndrome: Mechanisms and Clinical Relevance.Frontiers in pain research (Lausanne, Switzerland) · 2020Review
- Management of irritable bowel syndrome with diarrhea: a review of nonpharmacological and pharmacological interventions.Therapeutic advances in gastroenterology · 2019Review
- Psychotropics, Antidepressants, and Visceral Analgesics in Functional Gastrointestinal Disorders.Current gastroenterology reports · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlosetron is approved to treat women with severe IBS and diarrhea (IBS-D) who have failed standard therapy. In our study, we aimed to evaluate alosetron efficacy using new US Food and Drug Administration (FDA) endpoints and utilization in clinical practice.
methodsThis prospective, open-label, multicenter, observational 12-week study evaluated women with severe IBS-D enrolled in the alosetron prescribing program. The coprimary FDA endpoints were changes from baseline in stool consistency and abdominal pain severity. Responders achieved a 30% decrease compared with baseline in weekly average of the worst abdominal pain in the past 24 h, and a 50% or greater reduction from baseline in the number of days/week with at least one stool of type 6 (mushy) or type 7 (watery) consistency. Secondary endpoints included changes from baseline in stool frequency, fecal urgency and fecal incontinence.
resultsEnrolled patients (
conclusionIn a clinical practice setting study, alosetron demonstrated treatment success using a rigorous FDA composite endpoint and also improved multiple other IBS symptoms, including fecal urgency and incontinence in women with severe IBS-D [ClinicalTrials.gov identifier: NCT01257477].
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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.