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Linaclotide Improves Abdominal Pain and Bowel Habits in a Phase IIb Study of Patients with Irritable Bowel Syndrome.

Gastroenterology. 2010 Aug 26;

Authors: Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ

BACKGROUND & AIMS:: Linaclotide, a minimally absorbed, 14 amino-acid, peptide agonist of guanylate cyclase-C, has shown benefit in a proof-of-concept study for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). We assessed the efficacy and safety of linaclotide at a daily dose range of 75-600 mug in IBS-C. METHODS:: We performed a randomized, double-blind, multi-center, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 mug or placebo once daily for 12 weeks. Endpoints included change from baseline in daily bowel habits, daily abdominal symptoms, and weekly global assessments, in addition to responder criteria. RESULTS:: All doses of linaclotide significantly improved bowel habits, including frequency of spontaneous bowel movements (SBMs) and complete SBMs (primary endpoint), severity of straining, and stool consistency. Abdominal pain was significantly reduced from baseline, compared with placebo; mean changes in abdominal pain (assessed on a 5-point scale) from baseline were -0.71, -0.71, -0.90, and -0.86 for linaclotide doses of 75, 150, 300, and 600 mug, respectively, compared to -0.49 for placebo. Likewise, most doses of linaclotide significantly improved other abdominal symptoms, including discomfort and bloating, and global measures of IBS-C compared to placebo. Effects were observed within the first week and were sustained throughout 12 weeks of treatment. Except for diarrhea, the incidence of adverse events was similar between placebo and linaclotide groups. CONCLUSIONS:: Linaclotide, across a wide range of doses, significantly improved symptoms of IBS-C, including abdominal pain and bowel habits. Diarrhea was the only dose-dependent adverse event and was usually of mild or moderate severity.

PMID: 20801122 [PubMed - as supplied by publisher]

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