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Effects of treatment with eluxadoline on abdominal pain in patients with IBS-D: Additional post hoc analyses of Phase 3 trials

Neurogastroenterology & Motility Jan 30, 2020

Lembo AJ, et al. - Via analyses of the larger, pooled Phase 3 data set, researchers studied the impact of eluxadoline, a mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist that acts locally in the gastrointestinal tract and has been shown to lessen visceral hypersensitivity and regulate intestinal motility, on abdominal pain in patients with irritable bowel syndrome with diarrhea (IBS-D). They pooled data from two eluxadoline Phase 3 trials over 26 weeks to compare eluxadoline 100 mg twice daily to placebo. Worst abdominal pain (WAP) was estimated every day on a 0-10 scale. Of 1,615 individuals in the pooled data set, 806 were in the eluxadoline 100 mg group and 809 were in the placebo group. Eluxadoline showed consistent and sustained improvement in WAP vs placebo across a range of prospective and post hoc analyses despite small effect sizes. To fully understand the efficacy of a treatment, it is important to assess the WAP response across a range of measures.
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