Eluxadoline for Irritable Bowel Syndrome with Diarrhea.

@article{Lembo2016EluxadolineFI,
  title={Eluxadoline for Irritable Bowel Syndrome with Diarrhea.},
  author={Anthony J Lembo and Brian E. Lacy and Marc Zuckerman and Ron Schey and Leonard S. Dove and David A. Andrae and Jennifer M. Davenport and Gail McIntyre and Rocio Lopez and Lisa Turner and Paul S. Covington},
  journal={The New England journal of medicine},
  year={2016},
  volume={374 3},
  pages={
          242-53
        }
}
Background Effective and safe treatments are needed for patients who have irritable bowel syndrome (IBS) with diarrhea. We conducted two phase 3 trials to assess the efficacy and safety of eluxadoline, a new oral agent with mixed opioid effects (μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist), in patients with IBS with diarrhea. Methods We randomly assigned 2427 adults who had IBS with diarrhea to eluxadoline (at a dose of 75 mg or 100 mg) or placebo twice daily for 26 weeks… 

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References

SHOWING 1-10 OF 43 REFERENCES
Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study.
TLDR
Patients given eluxadoline were significantly more likely to be clinical responders, based on a composite of improvement in abdominal pain and stool consistency, in a phase 2 study of the mixed μ-opioid receptor agonist/δ-opIOid receptor antagonist in patients with IBS-D.
Rifaximin therapy for patients with irritable bowel syndrome without constipation.
TLDR
Among patients who had IBS without constipation, treatment with rifaximin for 2 weeks provided significant relief of IBS symptoms, bloating, abdominal pain, and loose or watery stools.
Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome
TLDR
Alosetron is effective at managing bowel urgency in women with diarrhea-predominant IBS and the IBS Global Improvement assessment correlated with improvements in bowel function and may be a useful tool in future IBS clinical trials.
Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials.
A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome.
TLDR
Alosetron hydrochloride, 1 mg twice daily for 12 weeks, is effective in relieving pain and some bowel-related symptoms in diarrhea-predominant female patients with IBS.
Loperamide in treatment of irritable bowel syndrome--a double-blind placebo controlled study.
TLDR
Self-titration of dose and administration in a single nightly dose was safe and efficient and Subjective overall response was also significantly better in the loperamide group.
Role of loperamide and placebo in management of irritable bowel syndrome (IBS)
TLDR
Improvement in diarrhea was not associated with any change in stool weight but was associated with reductions in stool frequency, and incidence of urgency, which was the only symptom that was significantly more common in the success group, compared with the group who did not feel better on loperamide.
A double-blind placebo-controlled trial with loperamide in irritable bowel syndrome.
TLDR
The trial shows a benefit of loperamide in an unselected cohort of IBS patients with regard to stool frequency, stool consistency, and the overall pain intensity, but with increased abdominal pain during the night.
A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS
TLDR
Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS.
...
...