In:
Therapeutic Advances in Gastroenterology, SAGE Publications, Vol. 11 ( 2018-01), p. 175628481879879-
Abstract:
Linaclotide, a guanylate cyclase C agonist, has been shown in clinical trials to improve symptoms of irritable bowel syndrome with constipation (IBS-C). Here we report data from a real-world study of linaclotide in the UK. Methods: This 1-year, multicentre, prospective, observational study in the UK enrolled patients aged 18 years and over initiating linaclotide for IBS-C. The primary assessment was change from baseline in IBS Symptom Severity Scale (IBS-SSS) score at 12 weeks, assessed in patients with paired baseline and 12-week data. Change from baseline in IBS-SSS score at 52 weeks was a secondary assessment. Adverse events were recorded. Results: In total, 202 patients were enrolled: 185 (91.6%) were female, median age was 44.9 years (range 18.1–77.2) and 84 (41.6%) reported baseline laxative use. Mean (standard deviation) baseline IBS-SSS score was 339 (92), with most patients ( n = 129; 66.8%) classified as having severe disease (score ⩾300). In patients with paired data, there was a significant mean (95% confidence interval) decrease in IBS-SSS score from baseline to 12 weeks [−77.0 (−96.3, −57.7); p 〈 0.001; n = 124] and baseline to 52 weeks [−70.7 (−95.0, −46.5); p 〈 0.001; n = 76]. Overall, 174 adverse events were reported in 77 (38.1%) patients, most commonly diarrhoea ( n = 54; 26.7%), abdominal pain ( n = 21; 10.4%) and abdominal distension ( n = 13; 6.4%). Conclusion: Linaclotide significantly improved IBS-SSS score at 12 and 52 weeks. These results provide insights into outcomes with linaclotide treatment over 1 year in patients with IBS-C in real-world clinical practice.
Type of Medium:
Online Resource
ISSN:
1756-2848
,
1756-2848
DOI:
10.1177/1756284818798791
Language:
English
Publisher:
SAGE Publications
Publication Date:
2018
detail.hit.zdb_id:
2440710-0
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