UK clinical experience up to 52 weeks with linaclotide for irritable bowel syndrome with constipation
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Author(s)
Type
Journal Article
Abstract
Background: 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.
Date Issued
2018-10-03
Date Acceptance
2018-07-25
Citation
Therapeutic Advances in Gastroenterology, 2018, 11, pp.1756284818798791-1756284818798791
ISSN
1756-2848
Publisher
SAGE Publications (UK and US)
Start Page
1756284818798791
End Page
1756284818798791
Journal / Book Title
Therapeutic Advances in Gastroenterology
Volume
11
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30302125
PII: 10.1177_1756284818798791
Subjects
irritable bowel syndrome with constipation
linaclotide
observational study
Publication Status
Published online
Coverage Spatial
England
Date Publish Online
2018-10-03