Digestive Diseases and Sciences

, Volume 55, Issue 4, pp 1090–1097

Efficacy and Safety of Lubiprostone in Patients with Chronic Constipation

Authors

    • Wake GastroenterologyWake Research Associates
  • Douglas Drossman
    • University of North Carolina Center for Functional GI and Mobility DisordersUniversity of North Carolina at Chapel Hill
  • John F. Johanson
    • University of Illinois College of Medicine
  • Ryuji Ueno
    • Sucampo Pharma Americas Inc.
Original Article

DOI: 10.1007/s10620-009-1068-x

Cite this article as:
Barish, C.F., Drossman, D., Johanson, J.F. et al. Dig Dis Sci (2010) 55: 1090. doi:10.1007/s10620-009-1068-x

Abstract

Aims

The aim of this study is to assess the efficacy and safety of lubiprostone in adults with chronic constipation.

Methods

This multicenter, parallel-group trial enrolled 237 patients with chronic constipation and randomized them to 4 weeks of double-blind treatment with oral lubiprostone 24 mcg or placebo twice daily. The primary efficacy endpoint was the number of spontaneous bowel movements (SBMs) after 1 week of treatment. Secondary evaluations included SBMs at weeks 2, 3, and 4; percentage of patients with a SBM within 24 h of first study dose; stool consistency; degree of straining; constipation severity; abdominal bloating and discomfort; global treatment effectiveness; and safety assessments.

Results

Lubiprostone-treated patients experienced greater mean numbers of SBMs at week 1 compared with placebo (5.89 versus 3.99, P = 0.0001), with significantly greater percentages having SBMs within 24 h of the first dose (61.3% versus 31.4%, P < 0.0001). At each assessment, SBM frequency and percentages of full responders (≥4 SBM per week) were significantly greater among lubiprostone-treated patients compared with placebo (P ≤ 0.0171). Lubiprostone-treated patients reported significant improvements in stool consistency, straining, and constipation severity at all weeks, and in abdominal bloating at week 1. Patient assessments of treatment effectiveness were significantly greater with lubiprostone compared with placebo at all weeks (P < 0.0004). Gastrointestinal-related disorders were the most common adverse events in both treatment groups.

Conclusions

In patients with chronic constipation, lubiprostone produced a bowel movement in the majority of individuals within 24 h of initial dosing, with sustained improvement in frequency as well as other constipation symptoms over 4 weeks of treatment.

Keywords

Lubiprostone Chronic constipation Stool frequency Bowel movement

Copyright information

© Springer Science+Business Media, LLC 2009