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Pubmed-Efficacy and Safety of Linaclotide in Patients with Irritable Bowel Syndrome with Constipation: Chinese Sub-Cohort Analysis of a Phase III, Randomized, Double-Blind, Placebo-controlled Trial


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J Dig Dis. 2022 Jan 12. doi: 10.1111/1751-2980.13081. Online ahead of print.

ABSTRACT

AIM: Linaclotide demonstrated potency in treating constipation-predominant irritable bowel syndrome (IBS-C), but few studies examined its use in Asian patients. Using data from a completed trial (NCT01880424), this sub-cohort analysis was performed to evaluate the efficacy and safety of linaclotide in Chinese patients with IBS-C.

METHODS: In this phase III, multicenter, double-blind, placebo-controlled trial, patients with IBS-C were randomized to receive linaclotide (290 μg/day) or placebo for 12 weeks. Efficacy was assessed with two co-primary responder endpoints (12-week abdominal pain/discomfort: ≥30% reduction in either score with neither deteriorating from baseline for ≥6 weeks; 12-week IBS degree of relief: score ≤2 for ≥6 weeks), seven secondary endpoints, and several additional endpoints.

RESULTS: In total, 659 Chinese patients with IBS-C were included to receive linaclotide (n=327) or placebo (n=332). The 12-week abdominal pain/discomfort endpoint was met in 62.1% and 53.3% of the linaclotide-treated and placebo-treated patients, respectively (odds ratio=1.43; 95% confidence interval [CI], 1.05-1.96; P=0.023); the 12-week IBS degree of relief endpoint was achieved in 32.7% and 16.9% of the linaclotide-treated and placebo-treated patients, respectively (odds ratio=2.40; 95% CI, 1.66-3.47; P<0.001). Linaclotide-treated patients had a shorter median time to the first SBM than placebo-treated patients (23.6 vs. 43.7 hours; P<0.001). Linaclotide demonstrated significantly greater improvement than placebo in all secondary endpoints from the first two weeks (P<0.001 for all). Diarrhea was reported in 8.3% of linaclotide-treated patients and 1.2% of placebo-treated patients.

CONCLUSIONS: Linaclotide (290 μg/day) was efficacious and well-tolerated in Chinese patients with IBS-C with rapid onset of effect.

PMID:35019221 | DOI:10.1111/1751-2980.13081

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