Abstract

Efficacy and Safety of Eluxadoline in Patients With Irritable Bowel Syndrome With Diarrhea Who Report Inadequate Symptom Control With Loperamide: RELIEF Phase 4 Study

Brenner DM1, Sayuk GS2,3, Gutman CR4, Jo E5, Elmes SJR4, Liu LWC6, Cash BD7. Am J Gastroenterol. 2019 Jul 26. doi: 10.14309/ajg.0000000000000327. [Epub ahead of print]

 
     

Author information

Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.

Washington University School of Medicine, St. Louis, Missouri, USA.

St. Louis VA Medical Center, St Louis, Missouri, USA.

Allergan plc, Madison, New Jersey, USA.

Allergan plc, Irvine, California, USA.

Toronto Western Hospital, University Health Network, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.

McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.

Abstract

OBJECTIVES: Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder with limited effective treatment options. We evaluated the efficacy and safety of eluxadoline in patients with IBS-D who reported inadequate symptom control with prior loperamide.

METHODS: Three hundred forty-six adults with IBS-D (Rome III criteria) were randomly assigned to placebo or eluxadoline 100 mg twice daily for 12 weeks. Patients recorded daily IBS-D symptoms, including worst abdominal pain (WAP) and stool consistency (through Bristol Stool Scale). The primary endpoint was proportion of composite responders, defined as patients who met daily composite response criteria (≥40% WAP improvement and <5 Bristol Stool Scale score) for at least 50% of treatment days, and recorded ≥60 days of diary entries over the 12-week period.

RESULTS: Over 12 weeks, a significantly greater proportion of eluxadoline patients achieved the primary composite responder endpoint compared to placebo (22.7% vs 10.3%, P = 0.002), and component endpoints of improvements in stool consistency (27.9% vs 16.7%, P = 0.01) and WAP (43.6% vs 31.0%, P = 0.02). Additionally, a greater proportion of eluxadoline patients met the composite responder endpoint assessed at monthly intervals compared to placebo (weeks 1-4: 14.0% vs 6.9%, P = 0.03; weeks 5-8: 26.7% vs 14.9%, P = 0.006; weeks 9-12: 30.8% vs 16.7%, P = 0.002). Rates of adverse events were comparable in both groups (37.4% vs 35.3%); no treatment-related serious adverse event, cases of sphincter of Oddi spasm, or pancreatitis were reported.

DISCUSSION: Eluxadoline appears safe and effective for treating IBS-D symptoms in patients with an intact gallbladder reporting inadequate relief with prior loperamide use.

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