Dataset Information

Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation.

ABSTRACT:

Background

Lubiprostone (8 ?g b.d.) received US Food and Drug Administration (FDA) approval in 2008 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in women aged ?18 years. In 2012, the FDA issued new guidance for IBS-C clinical trials, recommending a composite endpoint incorporating both abdominal pain and stool frequency.

Aim

In a post hoc analysis, similar criteria were applied to data from two pivotal, phase 3, double-blind, randomised trials of lubiprostone in patients with IBS-C.

Methods

Included patients had a baseline spontaneous bowel movement (SBM) frequency <3/week and abdominal pain or bloating ratings ?1.36 on a 5-point scale [0 (absent) to 4 (very severe)]. Responders (composite endpoint) had a mean pain reduction ?30% compared with baseline, and an increase from baseline of ?1 SBM/week for ?6 of the 12 treatment weeks. Lubiprostone effects on abdominal pain alone were also evaluated, as were bloating alone and in a composite endpoint with stool frequency.

Results

In pooled data, 325 patients received lubiprostone and 180 received placebo. Rates of response were higher with lubiprostone vs. placebo for the composite endpoint of improved pain and stool frequency (26.3% vs. 15.3%, respectively; P = 0.008) and the composite endpoint of improved bloating and stool frequency (23.8% vs. 12.6%, respectively; P = 0.012). Response rates were also higher with lubiprostone vs. placebo for abdominal pain alone (P = 0.005) and bloating alone (P = 0.012).

Conclusion

Lubiprostone was significantly more effective than placebo in improving abdominal pain or bloating, and also in composite endpoints that included stool frequency.

SUBMITTER: Chang L

PROVIDER: S-EPMC5215520 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation.

Chang L L Chey W D WD Drossman D D Losch-Beridon T T Wang M M Lichtlen P P Mareya S S

Alimentary pharmacology & therapeutics 20160927 10

<h4>Background</h4>Lubiprostone (8 μg b.d.) received US Food and Drug Administration (FDA) approval in 2008 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in women aged ≥18 years. In 2012, the FDA issued new guidance for IBS-C clinical trials, recommending a composite endpoint incorporating both abdominal pain and stool frequency.<h4>Aim</h4>In a post hoc analysis, similar criteria were applied to data from two pivotal, phase 3, double-blind, randomised trials of ...[more]

PMID: 27669680

Similar Datasets

Project description:Study objectivesSleep deficiency, psychological distress, daytime dysfunction, and abdominal pain are common in adults with irritable bowel syndrome. Prior research on individuals with chronic pain has identified the indirect effect of sleep on pain through psychological distress or daytime dysfunction; however, this effect is less clear in irritable bowel syndrome. The purpose of this study was to examine potential indirect effects of sleep on abdominal pain symptoms simultaneously through psychological distress and daytime dysfunction in adults with irritable bowel syndrome.MethodsDaily symptoms of nighttime sleep complaints (sleep quality and refreshment), psychological distress, daytime dysfunction (fatigue, sleepiness, and difficulty concentrating), and abdominal pain were collected in baseline assessments from 2 randomized controlled trials of 332 adults (mean age 42 years and 85% female) with irritable bowel syndrome. Structural equation modeling was used to examine the global relationships among nighttime sleep complaints, psychological distress, daytime dysfunction, and abdominal pain.ResultsThe structural equation modeling analyses found a strong indirect effect of poor sleep on abdominal pain via daytime dysfunction but not psychological distress. More than 95% of the total effect of nighttime sleep complaints on abdominal pain was indirect.ConclusionsThese findings suggest that the primary impact of nighttime sleep complaints on abdominal pain is indirect. The indirect effect appears primarily through daytime dysfunction. Such understanding provides a potential avenue to optimize personalized and hybrid behavioral interventions for adults with irritable bowel syndrome through addressing daytime dysfunction and sleep behaviors. Additional study integrating symptoms with biological markers is warranted to explore the underlying mechanisms accounting for these symptoms.Clinical trial registrationRegistry: ClinicalTrials.gov. Name: Nursing Management of Irritable Bowel Syndrome: Improving Outcomes, Nursing Management of IBS: Improving Outcomes. URLs: https://clinicaltrials.gov/ct2/show/NCT00167635, https://clinicaltrials.gov/ct2/show/NCT00907790. Identifiers: NCT00167635, NCT00907790.

Dataset Information

Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation.

Background

Aim

Methods

Results

Conclusion

Publications

Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets