RT Journal Article
T1 Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms.
A1 Serrano-Falcón, Blanca
A1 Delgado-Aros, Sílvia
A1 Mearin, Fermín
A1 Ciriza de Los Ríos, Constanza
A1 Serra, Jordi
A1 Mínguez, Miguel
A1 Montoro Huguet, Miguel
A1 Perelló, Antonia
A1 Santander, Cecilio
A1 Pérez Aisa, Ángeles
A1 Bañón-Rodríguez, Inmaculada
A1 Rey, Enrique
K1 abdominal pain
K1 constipation
K1 functional gastrointestinal diseases
K1 irritable bowel syndrome
AB 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 30% reduction in IBS symptom severity score (IBS-SSS) or IBS-SSS  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.
SN 1756-283X
YR 2019
FD 2019-08-05
LK https://hdl.handle.net/10668/26706
UL https://hdl.handle.net/10668/26706
LA en
DS RISalud
RD Apr 6, 2025