title: Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation.
abstract: BACKGROUND
  Irritable bowel syndrome with constipation (IBS-C) significantly decreases quality of life and the ability to perform daily living activities.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: GI Physiology Laboratory, University of Michigan Health System, Ann Arbor, 48109-0362, USA. wchey@umich.edu
authors.forename: W D
authors.initials: WD
authors.lastname: Chey
authors.forename: D A
authors.initials: DA
authors.lastname: Drossman
authors.forename: J F
authors.initials: JF
authors.lastname: Johanson
authors.forename: C
authors.initials: C
authors.lastname: Scott
authors.forename: R M
authors.initials: RM
authors.lastname: Panas
authors.forename: R
authors.initials: R
authors.lastname: Ueno
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000527:Alprostadil / Q000009:adverse effects / Q000031:analogs & derivatives*; D065101:Chloride Channel Agonists; D018118:Chloride Channels / Q000009:adverse effects; D003248:Constipation / Q000188:drug therapy*; D003672:Defecation / Q000187:drug effects; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D000068238:Lubiprostone; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D065101:Chloride Channel Agonists; D018118:Chloride Channels; D005765:Gastrointestinal Agents; D000068238:Lubiprostone; D000527:Alprostadil