TY - JOUR
T1 - Radar plots
T2 - A novel modality for displaying disparate data on the efficacy of eluxadoline for the treatment of irritable bowel syndrome with diarrhea
AU - Brenner, D. M.
AU - Dove, L. S.
AU - Andrae, D. A.
AU - Covington, P. S.
AU - Gutman, C.
AU - Chey, W. D.
N1 - Funding Information:
The authors received no compensation related to the development of the manuscript. Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. Darren M. Brenner has served as a consultant, advisor, and speaker for Allergan plc, AstraZeneca, Daiichi Sankyo, the GI Health Foundation, Ironwood Pharmaceuticals, Inc., Medscape LLC, Salix Pharmaceuticals/ValeantPharmaceuticals,andSynergyPharmaceuticals. Leonard S. Dove serves as a scientific consultant to Allergan plc. David A. Andrae is a former employee of Allergan plc. Paul S. Covington has acted as a scientific consultant for Actavis, Inc., an affiliate of Allergan plc. Catherine Gutman is an employee of Allergan plc and has received company stock options as part of compensation. William D. Chey has received grant support from Ironwood Pharmaceuticals, Inc., Nestlé, and Prometheus Laboratories; has served as an advisor or consultant for Allergan plc, Biomerica, IM Health, Ironwood Pharmaceuticals, Inc., Nestlé, Proctor & Gamble Pharmaceuticals, Prometheus Laboratories, QOL Medical, Ritter, and Salix Pharmaceuticals; and has served as a speaker for the GI Health Foundation.
PY - 2018/8
Y1 - 2018/8
N2 - 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.
AB - 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.
KW - abdominal pain
KW - diarrhea
KW - eluxadoline
KW - irritable bowel syndrome
KW - radar plots
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U2 - 10.1111/nmo.13331
DO - 10.1111/nmo.13331
M3 - Article
C2 - 29575372
AN - SCOPUS:85044344593
VL - 30
JO - Neurogastroenterology and Motility
JF - Neurogastroenterology and Motility
SN - 1350-1925
IS - 8
M1 - e13331
ER -