Irritable Bowel Syndrome
Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation
Version of Record online: 18 JAN 2012
© 2012 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 35, Issue 5, pages 587–599, March 2012
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
- Issue online: 3 FEB 2012
- Version of Record online: 18 JAN 2012
- Manuscript Revised: 20 DEC 2011
- Manuscript Accepted: 20 DEC 2011
- Manuscript Revised: 10 APR 2010
- Manuscript Received: 16 MAR 2010
Irritable bowel syndrome with constipation (IBS-C) significantly decreases quality of life and the ability to perform daily living activities.
To demonstrate the long-term safety, tolerability and patient outcomes of lubiprostone in patients with IBS-C.
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.
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.
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.