Lubiprostone Significantly Improves Symptom Relief Rates in Adults With Irritable Bowel Syndrome and Constipation (IBS-C): Data from Two Twelve-Week, Randomized, Placebo-Controlled, Double-Blind Trials

  • Drossman D
  • Chey W
  • Panas R
  • et al.
N/ACitations
Citations of this article
6Readers
Mendeley users who have this article in their library.
Get full text

Abstract

Lubiprostone is a novel type-2 chloride channel activator for the treatment of chronic idiopathic constipation in adults. In a dose-ranging, double-blind, placebo-controlled phase 2 study, lubiprostone improved relief of IBS symptoms and was well-tolerated. To test these results, two 12-week, phase 3, multicenter, double-blind, randomized, placebo-controlled studies of lubiprostone in adults with IBS-C were conducted. Adults (n=1167) diagnosed with IBS-C (Rome II Criteria) were enrolled and received lubiprostone (8 mcg BID; n=780) or placebo (n=387) for 12 weeks. Most were female (91.6%) and aged 18-65 years (91.7%). Primary efficacy was determined by a unique question: "How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits, and other IBS symptoms) over the past week compared to how you felt before you entered the study?" A 7-point balanced scale with a strict evaluation using the two highest scale points to qualify as a responder was used. Patients reporting at least moderate relief 4 out of 4 weeks or significant relief 2 out of 4 weeks were considered monthly responders. To qualify as an overall responder, patients had to be a monthly responder for at least 2 out of 3 months. During the evaluation period, patients discontinuing for any reason or reporting an increase in rescue medication use, lack of efficacy, or moderately or significantly worse relief were deemed non-responders. Patients receiving lubiprostone were nearly twice as likely to achieve overall response (LOCF) compared to those receiving placebo (lubiprostone 17.9% vs. placebo 10.1%; P=0.001). Individually, each study showed lubiprostone's superiority for overall response (P=0.009 and P=0.031). In combined studies, secondary endpoints included abdominal discomfort/pain, stool consistency, straining, constipation severity and QOL; these statistically significantly improved in patients receiving lubiprostone vs. placebo. Lubiprostone was well-tolerated, with a similar incidence of serious AEs (1% in each group) and related AEs (lubiprostone: 22% vs. placebo: 21%). The most common treatment-related AEs were nausea (8% vs. 4%, respectively) and diarrhea (6% vs. 4%, respectively). Abdominal pain was higher with placebo (5%) vs. lubiprostone (4%). Discontinuation rates for AEs were lower in the lubiprostone group (5%) vs. the placebo group (6%). Responder rates from this study may not be comparable to those in other studies since the new Phase 3 study definition is more restrictive than those previously reported. These results further demonstrate the efficacy and tolerability of 8 mcg BID lubiprostone for treatment of adults with IBS-C

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Cite

CITATION STYLE

APA

Drossman, D. A., Chey, W., Panas, R., Wahle, A., Scott, C., & Ueno, R. (2007). Lubiprostone Significantly Improves Symptom Relief Rates in Adults With Irritable Bowel Syndrome and Constipation (IBS-C): Data from Two Twelve-Week, Randomized, Placebo-Controlled, Double-Blind Trials. Gastroenterology, 132(7), 2586–2587. https://doi.org/10.1053/j.gastro.2007.04.022

Readers' Seniority

Tooltip

Professor / Associate Prof. 1

33%

PhD / Post grad / Masters / Doc 1

33%

Researcher 1

33%

Readers' Discipline

Tooltip

Agricultural and Biological Sciences 1

50%

Medicine and Dentistry 1

50%

Save time finding and organizing research with Mendeley

Sign up for free