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Effect of Linaclotide in Improving Quality of Life in Patients with Constipation-predominant Irritable Bowel Syndrome (IBS-C)

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Atluri, Dileep MD1; Falck-Ytter, Yngve MD2; Chandar, Apoorva MBBS, MA, MPH2; Bharucha, Adil MBBS, MD3

American Journal of Gastroenterology: October 2013 - Volume 108 - Issue - p S566
Abstracts: FUNCTIONAL BOWEL DISORDERS
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1. University Hospitals of Cleveland, Cleveland, OH;

2. Veterans Affairs, Cleveland, OH;

3. Mayo Clinic, Rochester, MN.

Purpose: Constipation-predominant irritable bowel syndrome (IBS-C) adversely affects quality of life of patients and has very few effective treatment options. Linaclotide, a new secretagogue approved for treatment of IBS-C by the Food and Drug Administration (FDA) may improve IBS-C symptoms according to recent randomized controlled trials (RCTs). We systematically reviewed the available evidence and conducted meta-analysis to evaluate the efficacy of linaclotide in improving IBS-related quality of life (IBS-QOL) in patients with IBS-C.

Methods: Data sources: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, SCO-PUS, CINAHL, and gastroenterology conference proceedings and abstracts. Study eligibility criteria: RCTs comparing linaclotide with placebo in adult patients with study period of at least 12 weeks, and that measured improvement in QOL using the IBS-QOL measure. IBS-QOL is a validated, self-reported, 34-item scale that is specific to IBS and can be used assess the impact of IBS and its treatments. Clinically meaningful improvement in IBS-QOL is defined as improvement in IBS-QOL score of >14 points. Study appraisal and synthesis methods: Articles were independently assessed by two investigators. Standardized forms were used for blinded duplicate data extraction of study participants, quality, methods, and clinically meaningful improvement in quality of life (IBS-QOL) with treatment.

Results: Of 110 identified citations, three RCTs enrolling 1,659 patients met the inclusion criteria. The meta-analysis revealed that in comparison to placebo, fewer patients on linaclotide failed to achieve clinically meaningful improvement in quality of life (IBS-QOL; 3 RCTs; 1,659 patients; RR=0.78; 95% CI 0.72-0.86). Limitations: Fewer studies were available at the time of this analysis. All the included studies were performed in tertiary care settings with highly selective patient cohorts and may not be generalizable. Some inconsistencies and missing data were noted.

Conclusion: Linaclotide appears to be moderately effective in improving IBS-C QOL in patients with IBS-C.

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