Effects of Linaclotide in Patients with Irritable Bowel Syndrome with Constipation or Chronic Constipation: a Meta-Analysis.
Clin Gastroenterol Hepatol. 2013 May 2;
Authors: Videlock EJ, Cheng V, Cremonini F
BACKGROUND: & Aims: Linaclotide is a minimally absorbed, 14 amino-acid peptide used to treat patients with irritable bowel syndrome with constipation (IBS-C) or chronic constipation (CC). We performed a meta-analysis to determine estimate the efficacy of linaclotide, compared with placebo, for patients with IBS-C or CC. METHODS: MEDLINE, EMBASE, and the Cochrane central register of controlled trials were searched for randomized, placebo-controlled trials examining the effect of linaclotide in adults with IBS-C or CC. Dichotomous results were pooled to yield a relative risk (RR), 95% confidence intervals (CI), and number needed to treat (NNT). RESULTS: The search identified 7 trials of linaclotide in patients with IBS-C or CC; 6 were included in the analysis. Two of 3 trials of IBS-C used the endpoint recommended by the US Food and Drug Administration: an increase from baseline of 1 or more complete spontaneous bowel movement (CSBM)/week and a 30% or more reduction from baseline in the weekly average of daily worst abdominal pain scores for 50% of the treatment weeks. Based on this endpoint, the RR for response to treatment with 290 μg linaclotide, compared to placebo, was 1.95 (95% CI, 1.3-2.9) and the NNT was 7 (95% CI, 5-11). For CC, based on data from 3 trials of patients with CC, the RR for the primary endpoint (more than 3 CSBMs/week and an increase in 1 or more CSBM/week, for 75% of weeks) was 4.26 for 290 μg linaclotide vs placebo (95% CI, 2.80-6.47), and the NNT was 7 (95% CI, 5-8). Linaclotide also increased stool consistency and reduced abdominal pain, bloating, and overall symptom severity in patients with IBS-C or CC. CONCLUSIONS: Based on a meta-analysis, linaclotide improves bowel function and reduces abdominal pain and overall severity of IBS-C or CC, compared with placebo.
PMID: 23644388 [PubMed - as supplied by publisher]