Effectiveness and tolerability of linaclotide in the treatment of IBS‐C in a “real‐life” setting: Results from a Portuguese single‐center study

• Published in: Neurogastroenterology and motility Vol. 31; no. 2; pp. e13508 - n/a
• Main Authors: Mascarenhas‐Saraiva, Miguel José, Mascarenhas‐Saraiva, Miguel
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.02.2019
• Subjects: abdominal pain; Abdominal Pain - etiology; Abdominal Pain - prevention & control; Adult; adverse event; Aged; bloating; bowel movements; Clinical trials; Constipation - drug therapy; Diarrhea; Female; Flatulence - etiology; Flatulence - prevention & control; Guanylyl Cyclase C Agonists - therapeutic use; Humans; IBS‐C; Intestine; Irritable bowel syndrome; Irritable Bowel Syndrome - complications; Irritable Bowel Syndrome - drug therapy; linaclotide; Male; Middle Aged; Pain; Patient Satisfaction; Patients; Peptides - therapeutic use; Portugal; Portugal; bloating; abdominal pain; IBS-C; linaclotide; adverse event; bowel movements; diarrhea
• ISSN: 1350-1925; 1365-2982
• DOI: 10.1111/nmo.13508

Background Although linaclotide has been approved to treat moderate to severe IBS‐C, no data are available on its effectiveness and tolerability in patients in a real‐life setting. Methods A prospective single‐center study of the effectiveness and tolerability of linaclotide was carried out on patients (n = 40) with moderate to severe IBS‐C, all fulfilling the Rome IV criteria. Clinical information was recorded using a dietary questionnaire at baseline, and 3 and 6 months after initiating treatment. The end‐points to measure effectiveness included abdominal pain and bloating (11‐NRS), the number of bowel movements and patient satisfaction. Tolerability was assessed through the frequency of adverse events. Key Results In terms of efficacy, an improvement in abdominal pain and in the intensity of bloating was evident in the cohort after 6 months of linaclotide therapy. The proportion of patients with moderate or severe symptoms of bloating fell from 93.3% to 33.3% and those with pain from 93.4% to 20%. Weekly bowel movements also improved and accordingly, 97% of the patients were moderately or very satisfied with the treatment. At the end of the study, diarrhea was the most frequent adverse event (10%), although it was considered mild in 66.7% of these subjects and moderate in 33.3%. A lack of efficacy (n = 3) and excessive diarrhea (n = 7) were motives for discontinuing the treatment. Conclusions and Inferences Linaclotide proved to be a safe and effective drug to reduce the main symptoms of IBS‐C in everyday clinical practice, with an improvement comparable to that seen in clinical trials. We have assessed the benefits of using Linaclotide to treat IBS‐C in a real‐life setting, demonstarting that it significantly improved both symptom severity and quality of life. Linaclotide is an effective and safe therapeutic option for IBS‐C in a real life, clinical setting.