UK clinical experience up to 52?weeks with linaclotide for irritable bowel syndrome with constipation
Linaclotide, a guanylate cyclase C agonist, has been shown in clinical trials to improve symptoms of irritable bowel syndrome with constipation (IBS-C). In this study, data from a real-world study of linaclotide in the UK are reported. 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. 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%). The authors concluded that 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.
Authors: Yiannakou Y, Agrawal A, Allen PB, Arebi N, Brown SR, Eugenicos MP, Farmer AD, McLain-Smith S, McLaughlin J, Sanders DS, Lawrance D, Emmanuel A. ; Full Source: Therapeutic advances in gastroenterology. 2018 Oct 3; 11:1756284818798791. doi: 10.1177/1756284818798791. eCollection 2018.