Eluxadoline offers IBS-D symptom relief to loperamide nonresponders

  • Brenner DM & al.
  • Am J Gastroenterol
  • 26 Jul 2019

  • International Clinical Digest
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Takeaway

  • When loperamide (Imodium) does not provide relief from irritable bowel syndrome with diarrhea (IBS-D), eluxadoline (Truberzi) can be a safe and effective alternative for patients who have intact gallbladders.

Why this matters

  • "Effective treatment options for IBS-D are limited," say researchers. "Loperamide is not indicated for long-term use and does not alleviate abdominal pain or bloating."

Study design

  • Researchers in this double-blinded, multinational phase 4 trial studied adult patients with IBS-D (N=346), randomly assigning them to receive either placebo or eluxadoline 100 mg twice daily for 12 weeks.
  • Primary endpoint was ≥40% improvement in worst abdominal pain (WAP) and
  • Funding: Allergan.

Key results

  • More patients in the eluxadoline group reached the primary endpoint than those in the placebo group (22.7% vs 10.3%; P=.002).
  • They also showed more improvements in stool consistency (27.9% vs 16.7%; P=.01) and WAP (43.6% vs 31.0%; P=.02).
  • Adverse event rates were similar in both groups (37.4% vs 35.3%).

Limitations

  • The trial was designed with 90% power to detect primary endpoint response.

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