Tags

Type your tag names separated by a space and hit enter

Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis.
Clin Gastroenterol Hepatol 2013; 11(9):1084-1092.e3; quiz e68CG

Abstract

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 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 (CIs), 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 end point recommended by the U.S. 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. On the basis of this end point, the RR for response to treatment with 290 μg linaclotide, compared with placebo, was 1.95 (95% CI, 1.3-2.9), and the NNT was 7 (95% CI, 5-11). For CC, on the basis of data from 3 trials of patients with CC, the RR for the primary end point (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 improved stool form and reduced abdominal pain, bloating, and overall symptom severity in patients with IBS-C or CC.

CONCLUSIONS

On the basis of a meta-analysis, linaclotide improves bowel function and reduces abdominal pain and overall severity of IBS-C or CC, compared with placebo.

Authors+Show Affiliations

Beth Israel Deaconess Medical Center, Harvard Medical School Boston, Massachusetts, USA. videlock@gmail.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Systematic Review

Language

eng

PubMed ID

23644388

Citation

Videlock, Elizabeth J., et al. "Effects of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation: a Meta-analysis." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 11, no. 9, 2013, pp. 1084-1092.e3; quiz e68.
Videlock EJ, Cheng V, Cremonini F. Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis. Clin Gastroenterol Hepatol. 2013;11(9):1084-1092.e3; quiz e68.
Videlock, E. J., Cheng, V., & Cremonini, F. (2013). Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 11(9), pp. 1084-1092.e3; quiz e68. doi:10.1016/j.cgh.2013.04.032.
Videlock EJ, Cheng V, Cremonini F. Effects of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation: a Meta-analysis. Clin Gastroenterol Hepatol. 2013;11(9):1084-1092.e3; quiz e68. PubMed PMID: 23644388.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis. AU - Videlock,Elizabeth J, AU - Cheng,Vivian, AU - Cremonini,Filippo, Y1 - 2013/05/02/ PY - 2013/01/30/received PY - 2013/04/08/revised PY - 2013/04/10/accepted PY - 2013/5/7/entrez PY - 2013/5/7/pubmed PY - 2014/3/19/medline KW - BSFS KW - Bristol Stool Form Scale KW - CC KW - CI KW - CSBM KW - Clinical Trials KW - Colon KW - FDA KW - Food and Drug Administration KW - Functional Bowel KW - IBS-C KW - ITT KW - NNT KW - RCT KW - RR KW - Systematic Review KW - TEAE KW - chronic constipation KW - complete spontaneous bowel movement KW - confidence interval KW - intention to treat KW - irritable bowel syndrome with constipation KW - number needed to treat KW - randomized controlled trial KW - relative risk KW - treatment emergent adverse event SP - 1084-1092.e3; quiz e68 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin. Gastroenterol. Hepatol. VL - 11 IS - 9 N2 - 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 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 (CIs), 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 end point recommended by the U.S. 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. On the basis of this end point, the RR for response to treatment with 290 μg linaclotide, compared with placebo, was 1.95 (95% CI, 1.3-2.9), and the NNT was 7 (95% CI, 5-11). For CC, on the basis of data from 3 trials of patients with CC, the RR for the primary end point (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 improved stool form and reduced abdominal pain, bloating, and overall symptom severity in patients with IBS-C or CC. CONCLUSIONS: On the basis of a meta-analysis, linaclotide improves bowel function and reduces abdominal pain and overall severity of IBS-C or CC, compared with placebo. SN - 1542-7714 UR - https://www.unboundmedicine.com/medline/citation/23644388/Effects_of_linaclotide_in_patients_with_irritable_bowel_syndrome_with_constipation_or_chronic_constipation:_a_meta_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(13)00601-0 DB - PRIME DP - Unbound Medicine ER -