- 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."
- 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.
- 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%).
The trial was designed with 90% power to detect primary endpoint response.