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

Aliment Pharmacol Ther. 2012 Mar;35(5):587-99. doi: 10.1111/j.1365-2036.2011.04983.x. Epub 2012 Jan 18.


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.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Adult
  • Alprostadil / adverse effects
  • Alprostadil / analogs & derivatives*
  • Chloride Channel Agonists
  • Chloride Channels / adverse effects
  • Constipation / drug therapy*
  • Defecation / drug effects
  • Female
  • Gastrointestinal Agents / adverse effects*
  • Humans
  • Irritable Bowel Syndrome / drug therapy*
  • Lubiprostone
  • Male
  • Middle Aged
  • Quality of Life / psychology
  • Time Factors
  • Treatment Outcome


  • Chloride Channel Agonists
  • Chloride Channels
  • Gastrointestinal Agents
  • Lubiprostone
  • Alprostadil