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Viberzi controls gut symptoms in patients with IBS-D
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SAN DIEGO — Patients with diarrhea-predominant irritable bowel syndrome who previously had an inadequate response to loperamide therapy were able to achieve symptom control with Viberzi, according to data presented at Digestive Disease Week.
“A significant percentage of individuals try or are prescribed over-the-counter loperamide,” Darren M. Brenner, MD, of Northwestern Feinberg School of Medicine, said in his presentation. “I think we’d concede or grant that loperamide will work for improving stool form or stool frequency, but it doesn’t do anything for the gut symptoms of IBS, the abdominal pain, discomfort, bloating and distention.”
Brenner and colleagues tested the efficacy and safety of Viberzi (eluxadoline, Allergan) — a mixed mu- and kappa-opioid receptor agonist and delta-opioid receptor antagonist — for the treatment of patients with IBS-D who experienced inadequate symptom control while on loperamide therapy in a phase 4 study known as the RELIEF trial. They randomly assigned 346 patients to receive 100 mg of eluxadoline or placebo twice daily for 12 weeks.
Patients kept track of daily IBS-D symptoms including worst abdominal pain (WAP) and stool consistency using the Bristol Stool Scale. The primary endpoint was the proportion of patients with a 40% or greater improvement in WAP compared with baseline and Bristol Stool Scale score less than 5 for at least 50% of treatment days. Researchers defined weekly composite responders using two criteria. In the first, patients had to achieve the WAP and stool consistency primary endpoint response on at least 4 days that week. In the second, they needed a weekly average WAP improvement of at least 40% and a reduction in the number of days with a stool scale score 6 to 7 compared with baseline of at least 50%.
Brenner and colleagues found that compared with placebo, a higher proportion of patients in the eluxadoline group achieved composite (22.7% vs. 10.3%; P = .022), WAP (43.6% vs. 31%; P = .0174) and stool consistency (27.9% vs. 16.7%; P = .0119) endpoints. More patients in the eluxadoline group also achieved improvement in WAP at thresholds of 30% (50.6% vs. 37.4%; P = .015), 40% (43.6% vs. 31%; P = .0174) and 50% (35.5% vs. 23.6%; P = .0166) compared with placebo.
Additionally, more patients treated with exluadoline responded to therapy for all weeks using both criteria compared with placebo.
“Across distinct composite endpoints, eluxadoline looks to be an effective treatment option in patients with IBS-D who reported prior inadequate relief with loperamide,” Brenner said. – by Alex Young
Reference:
Brenner DM, et al. Abstract 440. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosures: Brenner reports he has served as a consultant and advisor for Allergan, Ironwood, Salix, Shire and Synergy. Please see the meeting disclosure index for all other authors’ relevant financial disclosures.