Takeaway
- Linaclotide treatment was associated with significant reduction in symptom severity among patients with irritable bowel syndrome with constipation (IBS-C) at 12 and 52 weeks of treatment.
- Linaclotide treatment showed a favourable and consistent safety profile.
Why this matters
- Findings support results from previous phase 3 trials of linaclotide in patients with moderate to severe IBS-C and could translate into real-world setting of secondary and tertiary care centers in the United Kingdom.
Study design
- 202 patients (median age, 44.9 years) with IBS-C who were initiated on linaclotide therapy, at a standard dose of 290 μg orally once daily were evaluated.
- Participants completed a validated IBS Symptom Severity Scale (IBS-SSS) score questionnaire at baseline and at 4, 12 and 52 weeks after treatment initiation.
- IBS-SSS score stratified disease severity as normal (<75), mild (75 to <175), moderate (175 to <300) and severe (⩾300).
- Funding: Allergan plc.
Key results
- Majority (66.8%) of patients had severe IBS-C.
- 41.6% patients reported baseline laxative use.
- Mean IBS-SSS score reduced significantly from baseline at 12 (mean change, [MC], −77.0; P<.001) and 52 (MC, −70.7; P<.001) weeks after linaclotide initiation.
- A greater mean change in IBS-SSS score was observed in patients with severe vs moderate IBS-C at 12 (MC, −90.7 vs −65.7; Pboth<.001) and 52 (MC, −91.1; P<.001 vs −57.2; P<.01) weeks.
- 38.1% patients reported 174 adverse events, most commonly diarrhoea (26.7%), abdominal pain (10.4%) and abdominal distension (6.4%).
Limitations
- Observational study.
- Absence of comparator group.
References
References