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Linaclotide for the treatment of chronic idiopathic constipation
▶ Lembo AJ, Schneier HA, Shiff SJ, et al. Two randomized trials of linaclotide for chronic constipation. N Engl J Med 2011;365:527–36.
Chronic idiopathic constipation (CIC) is common in the community, with a population prevalence of between 5% and 20%. The condition is difficult to treat, with a significant proportion of individuals with CIC either non-responsive to or dissatisfied with the efficacy of laxatives. New pharmaceutical agents of proven benefit are therefore required. Linaclotide is a guanylate cyclase C receptor agonist that has shown promise in previous phase II randomised controlled trials for CIC.
Lembo et al report the results of two large multicentre phase III randomised controlled trials, studying the efficacy of 12 weeks of linaclotide in CIC. The authors recruited over 1000 predominantly female subjects meeting their criteria for CIC and randomised them in a 1:1:1 ratio to receive linaclotide 290 µg, linaclotide 145 µg or placebo once daily. The primary efficacy measure was the passage of three or more complete, spontaneous bowel movements per week, together with an increase of one complete, spontaneous bowel movement from baseline, for 9 of the 12 study weeks. Secondary end points included improvements in stool frequency and consistency, straining, abdominal discomfort, bloating and constipation severity, as well as satisfaction with treatment and quality of …
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