Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms
Serrano-Falcón, Blanca (Hospital Clínico San Carlos (Madrid))
Delgado-Aros, Sílvia (Hospital del Mar (Barcelona, Catalunya))
Mearin, Fermín 1956- (Centro Médico Teknon)
Ciriza de los Ríos, Constanza (Hospital Universitario 12 de Octubre (Madrid))
Serra Pueyo, Jordi (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Mínguez, Miguel (Universitat de València)
Montoro Huguet, Miguel (Hospital San Jorge (Huesca))
Perelló, Antonia (Hospital de Viladecans)
Santander, Cecilio (Universidad Autónoma de Madrid)
Pérez-Aisa, Ángeles (Agencia Sanitaria Costa del Sol)
Bañón-Rodríguez, Inmaculada (Allergan plc)
Rey, Enrique (Hospital Clínico San Carlos (Madrid))

Data:	2019
Resum:	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. 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. 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%). Linaclotide improves IBS-C symptoms, including digestive nonintestinal and extra-digestive symptoms. A clinical response at week 4 may predict response at week 12.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Abdominal pain ; Constipation ; Functional gastrointestinal diseases ; Irritable bowel syndrome
Publicat a:	Therapeutic Advances in Gastroenterology, Vol. 12 (august 2019) , ISSN 1756-2848

DOI: 10.1177/1756284819857358
PMID: 31428193

14 p, 478.1 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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