Serrano-Falcón, BlancaDelgado-Aros, SílviaMearin, FermínCiriza de Los Ríos, ConstanzaSerra, JordiMínguez, MiguelMontoro Huguet, MiguelPerelló, AntoniaSantander, CecilioPérez Aisa, ÁngelesBañón-Rodríguez, InmaculadaRey, Enrique2025-01-072025-01-072019-08-051756-283Xhttps://hdl.handle.net/10668/26706Linaclotide 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.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/abdominal painconstipationfunctional gastrointestinal diseasesirritable bowel syndromeresearch article31428193open access10.1177/1756284819857358PMC6683318https://journals.sagepub.com/doi/pdf/10.1177/1756284819857358https://pmc.ncbi.nlm.nih.gov/articles/PMC6683318/pdf