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Clinical Summary

Linaclotide improves symptom severity in irritable bowel syndrome with constipation

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


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