Abstract

Radar plots: A novel modality for displaying disparate data on the efficacy of eluxadoline for the treatment of irritable bowel syndrome with diarrhea

Brenner DM1, Dove LS2, Andrae DA3, Covington PS4, Gutman C5, Chey WD6. Neurogastroenterol Motil. 2018 Mar 25:e13331. doi: 10.1111/nmo.13331. [Epub ahead of print]
 
     

Author information

1 Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

2 Consultant to Allergan plc, Madison, NJ, USA.

3 Former employee of Allergan plc, Madison, NJ, USA.

4 Former employee of Furiex Pharmaceuticals, Inc., an affiliate of Allergan plc, Madison, NJ, USA.

5 Allergan plc, Madison, NJ, USA.

6 University of Michigan, Ann Arbor, MI, USA.

Abstract

BACKGROUND: Patients with irritable bowel syndrome with diarrhea (IBS-D) experience a range of abdominal and bowel symptoms; successful management requires alleviation of this constellation of symptoms. Eluxadoline, a locally active mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, is approved for the treatment of IBS-D in adults based on the results of 2 Phase 3 studies. Radar plots can facilitate comprehensive, visual evaluation of diverse but interrelated efficacy endpoints.

METHODS: Two double-blind, placebo-controlled, Phase 3 trials (IBS-3001 and IBS-3002) randomized patients meeting Rome III criteria for IBS-D to twice-daily eluxadoline 75 or 100 mg or placebo. Radar plots were prepared showing pooled Weeks 1-26 response rates for the primary efficacy composite endpoint (simultaneous improvement in abdominal pain and stool consistency), stool consistency, abdominal pain, urgency-free days, and adequate relief, and change from baseline to Week 26 in IBS-D global symptom score, abdominal discomfort, abdominal pain, abdominal bloating, and daily number of bowel movements.

KEY RESULTS: The studies enrolled 2428 patients. Eluxadoline increased Weeks 1-26 responder proportions vs placebo for the composite endpoint, stool consistency, abdominal pain, urgency-free days, and adequate relief. Changes from baseline to Week 26 in IBS-D global symptom score, abdominal discomfort, abdominal pain, abdominal bloating, and number of bowel movements were greater with eluxadoline vs placebo.

CONCLUSIONS AND INFERENCES: Data presentation in radar plot format facilitates interpretation across multiple domains, demonstrating that eluxadoline treatment led to improvements vs placebo across 13 endpoints representing the range of symptoms experienced by patients with IBS-D.

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