Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies.
Neurogastroenterol MotilSep 1, 2026
Lin Chang, Kyle Staller, Lesley A Houghton et al.
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In 30 seconds
This post hoc analysis of eight randomized, placebo-controlled trials evaluated linaclotide's efficacy and safety in adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), stratified by age and menopausal status. Linaclotide significantly increased weekly complete spontaneous bowel movement (CSBM) frequency compared to placebo, with improvements observed within 1.5 to 3 weeks.
Key findings
- Linaclotide increased weekly CSBM frequency from baseline versus placebo in IBS-C patients under 65 years (2.3 vs 0.8).
- In CIC patients over 65 years, linaclotide 145 µg increased CSBM frequency to 2.3 compared to 0.9 for placebo.
- Median time to an increase in weekly CSBM rate of ≥1 was shorter with linaclotide, with IBS-C patients under 65 seeing results in 2 weeks.
- Abdominal symptoms improved significantly across all age and menopausal subgroups.
Why it matters
Understanding the efficacy of linaclotide across different age and menopausal groups can help clinicians tailor treatment for patients with IBS-C and CIC, ensuring effective management of symptoms.