Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
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- dc.contributor.author Serrano-Falcón, Blanca
- dc.contributor.author Delgado Aros, Silvia
- dc.contributor.author Mearin, Fermín
- dc.contributor.author Ciriza, Constanza
- dc.contributor.author Serra, Jordi
- dc.contributor.author Mínguez, Miguel
- dc.contributor.author Montoro Huguet, Miguel
- dc.contributor.author Perelló, Antonia
- dc.contributor.author Santander, Cecilio
- dc.contributor.author Pérez Aisa, Ángeles
- dc.contributor.author Bañón-Rodríguez, Inmaculada
- dc.contributor.author Rey, Enrique
- dc.date.accessioned 2020-04-29T07:30:26Z
- dc.date.available 2020-04-29T07:30:26Z
- dc.date.issued 2019
- dc.description.abstract Background: Linaclotide is approved for the treatment of moderate-to-severe irritable bowel syndrome (IBS) with constipation (IBS-C) in adults. This study aimed to assess factors predictive of a clinical response and improvements in non-IBS symptoms with linaclotide treatment in a Spanish patient population. Methods: In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks. The primary endpoint was clinical response at week 12, defined as >30% reduction in IBS symptom severity score (IBS-SSS) or IBS-SSS <75 plus self-reported response of feeling 'better' or 'much better' versus the baseline. Digestive nonintestinal and extra-digestive symptom scores were assessed. Baseline characteristics and week 4 clinical response were assessed as predictors of week 12 clinical response. Results: A total of 96 patients were eligible; 91 were female and the mean age was 47.4 years. Mean (SD) baseline IBS-SSS was 371 (72.5). In the intention-to-treat and per-protocol populations, 22.9% and 31.7% were clinical responders at week 4, respectively, and 25.0% and 36.7% were clinical responders at week 12. Digestive nonintestinal and extra-digestive symptom scores were significantly improved at weeks 4 and 12. Baseline characteristic was not associated with week 12 clinical response; however, clinical response at week 4 was predictive of response at week 12 (OR: 6.5; 95%IC: 2.1-19.8). The most common adverse event was diarrhea inclusive of loose or watery stools (35.4%). Conclusions: Linaclotide improves IBS-C symptoms, including digestive nonintestinal and extra-digestive symptoms. A clinical response at week 4 may predict response at week 12.
- dc.format.mimetype application/pdf
- dc.identifier.citation Serrano-Falcón B, Delgado-Aros S, Mearin F, Ciriza de Los Ríos C, Serra J, Mínguez M, et al. Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms. Therap Adv Gastroenterol. 2019 Aug 5; 12: 1-14. DOI: 10.1177/1756284819857358
- dc.identifier.doi http://dx.doi.org/10.1177/1756284819857358
- dc.identifier.issn 1756-283X
- dc.identifier.uri http://hdl.handle.net/10230/44365
- dc.language.iso eng
- dc.publisher SAGE Publications
- dc.rights Copyright © The Author(s), 2019. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://www.creativecommons.org/licenses/by-nc/4.0/
- dc.subject.keyword Abdominal pain
- dc.subject.keyword Constipation
- dc.subject.keyword Functional gastrointestinal diseases
- dc.subject.keyword Irritable bowel syndrome
- dc.title Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/acceptedVersion