PMID- 22251419
OWN - NLM
STAT- MEDLINE
DCOM- 20120501
LR  - 20220409
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 35
IP  - 5
DP  - 2012 Mar
TI  - Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with 
      irritable bowel syndrome with constipation.
PG  - 587-99
LID - 10.1111/j.1365-2036.2011.04983.x [doi]
AB  - 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.
CI  - (c) 2012 Blackwell Publishing Ltd.
FAU - Chey, W D
AU  - Chey WD
AD  - GI Physiology Laboratory, University of Michigan Health System, Ann Arbor, 
      48109-0362, USA. wchey@umich.edu
FAU - Drossman, D A
AU  - Drossman DA
FAU - Johanson, J F
AU  - Johanson JF
FAU - Scott, C
AU  - Scott C
FAU - Panas, R M
AU  - Panas RM
FAU - Ueno, R
AU  - Ueno R
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120118
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (Chloride Channel Agonists)
RN  - 0 (Chloride Channels)
RN  - 0 (Gastrointestinal Agents)
RN  - 7662KG2R6K (Lubiprostone)
RN  - F5TD010360 (Alprostadil)
SB  - IM
CIN - Aliment Pharmacol Ther. 2012 Apr;35(8):962-3. PMID: 22436041
MH  - Activities of Daily Living
MH  - Adult
MH  - Alprostadil/adverse effects/*analogs & derivatives
MH  - Chloride Channel Agonists
MH  - Chloride Channels/adverse effects
MH  - Constipation/*drug therapy
MH  - Defecation/drug effects
MH  - Female
MH  - Gastrointestinal Agents/*adverse effects
MH  - Humans
MH  - Irritable Bowel Syndrome/*drug therapy
MH  - Lubiprostone
MH  - Male
MH  - Middle Aged
MH  - Quality of Life/psychology
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2012/01/19 06:00
MHDA- 2012/05/02 06:00
CRDT- 2012/01/19 06:00
PHST- 2010/03/16 00:00 [received]
PHST- 2010/04/10 00:00 [revised]
PHST- 2011/12/20 00:00 [revised]
PHST- 2011/12/20 00:00 [accepted]
PHST- 2012/01/19 06:00 [entrez]
PHST- 2012/01/19 06:00 [pubmed]
PHST- 2012/05/02 06:00 [medline]
AID - 10.1111/j.1365-2036.2011.04983.x [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2012 Mar;35(5):587-99. doi: 
      10.1111/j.1365-2036.2011.04983.x. Epub 2012 Jan 18.