Trial reportNeurogastroenterology and motility2026
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.
Trial report in Neurogastroenterology and motility, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
backgroundThis post hoc study explored the effect of age and age-defined menopausal status on linaclotide efficacy and safety in adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
methodsData were pooled from eight randomized, placebo-controlled studies of linaclotide 72 μg (CIC), 145 μg (CIC), or 290 μg (IBS-C). Patients were stratified by age (< 65 years; ≥ 65 years) and female patients by age-defined menopausal status (premenopausal: ≤ 45 years; postmenopausal: > 45 years) as a surrogate for clinically confirmed menopausal status. Efficacy endpoints included change from baseline and time to response in complete spontaneous bowel movement (CSBM) frequency and abdominal symptoms.
resultsLinaclotide increased weekly CSBM frequency from baseline versus placebo across age (IBS-C, < 65 years, placebo: 0.8; 290 μg: 2.3; ≥ 65 years, placebo: 0.9; 290 μg: 2.6; CIC, < 65 years, placebo: 0.7; 72 μg: 1.7; 145 μg: 2.0; ≥ 65 years, placebo: 0.9; 72 μg: 1.5; 145 μg: 2.3) and menopausal subgroups. Abdominal symptoms reduced from baseline versus placebo across all subgroups. Median time (weeks) to an increase from baseline in weekly CSBM rate of ≥ 1 was shorter with linaclotide versus placebo across age (IBS-C, < 65 years, placebo: 4.0; 290 μg: 2.0; ≥ 65 years, placebo: 3.0; 290 μg: 2.0; CIC, < 65 years, placebo: 4.0; 72 μg: 3.0; 145 μg: 2.0; ≥ 65 years, placebo: 5.0; 72 μg: 3.0; 145 μg: 1.5) and age-defined menopausal subgroups.
conclusionIn this exploratory post hoc analysis, linaclotide was associated with improvements in bowel and abdominal symptoms across age and age-defined menopausal subgroups, with a safety profile consistent with previous studies, suggesting that age and menopausal status did not meaningfully influence treatment outcomes.
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