Irritable Bowel Syndrome

Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation

  1. W. D. Chey1,*,
  2. D. A. Drossman2,
  3. J. F. Johanson3,
  4. C. Scott4,
  5. R. M. Panas4,
  6. R. Ueno4

Article first published online: 18 JAN 2012

DOI: 10.1111/j.1365-2036.2011.04983.x

Issue

Alimentary Pharmacology & Therapeutics

Alimentary Pharmacology & Therapeutics

Volume 35, Issue 5, pages 587–599, March 2012

Additional Information

How to Cite

Chey, W. D., Drossman, D. A., Johanson, J. F., Scott, C., Panas, R. M. and Ueno, R. (2012), Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation. Alimentary Pharmacology & Therapeutics, 35: 587–599. doi: 10.1111/j.1365-2036.2011.04983.x

Author Information

  1. 1

    GI Physiology Laboratory, University of Michigan Health System, Ann Arbor, MI, USA

  2. 2

    Division of Gastroenterology & Hepatology, University of North Carolina Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

  3. 3

    University of Illinois, College of Medicine at Rockford, Rockford, IL, USA

  4. 4

    Sucampo Pharmaceuticals, Inc., Bethesda, MD, USA

*Correspondence to:
Prof. W. D. Chey, GI Physiology Laboratory, University of Michigan Health System, 3912 Taubman Center, SPC 0362, Ann Arbor, MI 48109-0362, USA.
E-mail: wchey@umich.edu

Publication History

  1. Issue published online: 3 FEB 2012
  2. Article first published online: 18 JAN 2012
  3. Manuscript Revised: 20 DEC 2011
  4. Manuscript Accepted: 20 DEC 2011
  5. Manuscript Revised: 10 APR 2010
  6. Manuscript Received: 16 MAR 2010

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Summary

Background

Irritable bowel syndrome with constipation (IBS-C) significantly decreases quality of life and the ability to perform daily living activities.

Aim

To demonstrate the long-term safety, tolerability and patient outcomes of lubiprostone in patients with IBS-C.

Methods

This extension study enrolled 522 IBS-C patients who had completed one of two randomised phase 3 studies. All enrolled patients received open-label lubiprostone orally for 36-weeks (8 mcg, twice daily). The primary objective was the assessment of long-term safety and tolerability, monitored via adverse events (AEs), laboratory parameters and vital signs. Additional outcome endpoints included monthly responder rates and patient evaluations of IBS-C symptom severity and impact on quality of life.

Results

The evaluable safety population comprised of 520 patients; 476 of which had patient reported outcome data available. The overall safety profile of lubiprostone during this study was similar to that observed in the preceding phase 3 studies. The most common AEs were diarrhoea (11.0%), nausea (11.0%), urinary tract infection (9.0%), sinusitis (9.0%) and abdominal distention (5.8%). Diarrhoea and nausea were the most common treatment-related AEs. No serious AEs were considered treatment-related. Seventeen patients discontinued due to a treatment-related AE, of which diarrhoea and nausea accounted for six (1.2%) and three (0.6%) respectively. For responder rates and patient-evaluated parameters (n = 476), all groups experienced significant improvements from baseline, with initial improvements maintained throughout the study.

Conclusion

In patients with irritable bowel syndrome with constipation, lubiprostone 8 mcg twice daily was found to be safe and well tolerated over 9–13 months of treatment.

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