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Rifaximin and eluxadoline - newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron?
Expert Opin Pharmacother. 2016; 17(3):311-22.EO

Abstract

INTRODUCTION

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common functional gastrointestinal condition in which patients experience abdominal pain, diarrhea, bloating, cramps, flatulence, fecal urgency, and incontinence.

AREAS COVERED

We review two recently approved therapies that focus on treating underlying pathogenic mechanisms of IBS-D: (1) the non-absorbable antibiotic rifaximin, and (2) the opioid receptor agonist/antagonist eluxadoline. We compare the safety and efficacy data emerging from rifaximin and eluxadoline registration trials with safety and efficacy data from the alosetron clinical development program.

EXPERT OPINION

The rifaximin and eluxadoline clinical development programs for IBS-D have demonstrated significant improvement in IBS-D endpoints compared to placebo. Direct comparison of primary endpoint results from the alosetron, rifaximin, and eluxadoline pivotal trials is not possible; however, general estimates of efficacy can be made, and these demonstrate similar and significantly greater responses to 'adequate relief' and a composite endpoint of abdominal pain/stool form for each agent compared to placebo. With the recent approval in the United States of rifaximin and eluxadoline for IBS-D, how should clinicians employ these agents? We suggest that they be utilized sequentially, taking into consideration patient symptoms and severity, prior medical history, mode of action, cost, availability, managed care coverage, and adverse event profiles.

Authors+Show Affiliations

a Gastroenterology Division , University of South Alabama , Mobile , AL , USA.b Division of Gastroenterology & Hepatology , Dartmouth-Hitchcock Medical Center , Lebanon , NH , USA.c Clinical Development & Medical Affairs , Prometheus Laboratories Inc ., San Diego , CA , USA.c Clinical Development & Medical Affairs , Prometheus Laboratories Inc ., San Diego , CA , USA.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

26559529

Citation

Cash, Brooks D., et al. "Rifaximin and Eluxadoline - Newly Approved Treatments for Diarrhea-predominant Irritable Bowel Syndrome: what Is Their Role in Clinical Practice Alongside Alosetron?" Expert Opinion On Pharmacotherapy, vol. 17, no. 3, 2016, pp. 311-22.
Cash BD, Lacy BE, Rao T, et al. Rifaximin and eluxadoline - newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron? Expert Opin Pharmacother. 2016;17(3):311-22.
Cash, B. D., Lacy, B. E., Rao, T., & Earnest, D. L. (2016). Rifaximin and eluxadoline - newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron? Expert Opinion On Pharmacotherapy, 17(3), 311-22. https://doi.org/10.1517/14656566.2016.1118052
Cash BD, et al. Rifaximin and Eluxadoline - Newly Approved Treatments for Diarrhea-predominant Irritable Bowel Syndrome: what Is Their Role in Clinical Practice Alongside Alosetron. Expert Opin Pharmacother. 2016;17(3):311-22. PubMed PMID: 26559529.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rifaximin and eluxadoline - newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron? AU - Cash,Brooks D, AU - Lacy,Brian E, AU - Rao,Tharaknath, AU - Earnest,David L, Y1 - 2015/12/08/ PY - 2015/11/13/entrez PY - 2015/11/13/pubmed PY - 2016/7/15/medline KW - 5-HT3 receptor antagonist KW - adequate relief KW - alosetron KW - composite endpoint of abdominal pain and stool consistency KW - delta opioid receptor (δOR) antagonist KW - diarrhea-predominant irritable bowel syndrome KW - eluxadoline KW - mu opioid receptor (μOR) agonist KW - non-absorbable antibiotic KW - rifaximin SP - 311 EP - 22 JF - Expert opinion on pharmacotherapy JO - Expert Opin Pharmacother VL - 17 IS - 3 N2 - INTRODUCTION: Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common functional gastrointestinal condition in which patients experience abdominal pain, diarrhea, bloating, cramps, flatulence, fecal urgency, and incontinence. AREAS COVERED: We review two recently approved therapies that focus on treating underlying pathogenic mechanisms of IBS-D: (1) the non-absorbable antibiotic rifaximin, and (2) the opioid receptor agonist/antagonist eluxadoline. We compare the safety and efficacy data emerging from rifaximin and eluxadoline registration trials with safety and efficacy data from the alosetron clinical development program. EXPERT OPINION: The rifaximin and eluxadoline clinical development programs for IBS-D have demonstrated significant improvement in IBS-D endpoints compared to placebo. Direct comparison of primary endpoint results from the alosetron, rifaximin, and eluxadoline pivotal trials is not possible; however, general estimates of efficacy can be made, and these demonstrate similar and significantly greater responses to 'adequate relief' and a composite endpoint of abdominal pain/stool form for each agent compared to placebo. With the recent approval in the United States of rifaximin and eluxadoline for IBS-D, how should clinicians employ these agents? We suggest that they be utilized sequentially, taking into consideration patient symptoms and severity, prior medical history, mode of action, cost, availability, managed care coverage, and adverse event profiles. SN - 1744-7666 UR - https://www.unboundmedicine.com/medline/citation/26559529/Rifaximin_and_eluxadoline___newly_approved_treatments_for_diarrhea_predominant_irritable_bowel_syndrome:_what_is_their_role_in_clinical_practice_alongside_alosetron L2 - http://www.tandfonline.com/doi/full/10.1517/14656566.2016.1118052 DB - PRIME DP - Unbound Medicine ER -