PMID- 24716835
OWN - NLM
STAT- MEDLINE
DCOM- 20151104
LR  - 20220317
IS  - 1526-4637 (Electronic)
IS  - 1526-2375 (Print)
IS  - 1526-2375 (Linking)
VI  - 15
IP  - 11
DP  - 2014 Nov
TI  - A randomized study of lubiprostone for opioid-induced constipation in patients 
      with chronic noncancer pain.
PG  - 1825-34
LID - 10.1111/pme.12437 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of oral lubiprostone for relieving 
      symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer 
      pain. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial. 
      SETTING: Seventy-nine US and Canadian centers. SUBJECTS: Patients aged >/= 18 years 
      with OIC, defined as <3 spontaneous bowel movements (SBMs) per week. METHODS: 
      Patients received lubiprostone 24 mcg or placebo twice daily for 12 weeks. The 
      primary endpoint was change from baseline in SBM frequency at week 8. RESULTS: 
      Among randomized patients (N=418; lubiprostone, N=210; placebo, N=208), most 
      completed the study (lubiprostone, 67.1%; placebo, 69.7%). The safety and 
      efficacy (intent-to-treat) populations included 414 (lubiprostone, N=208; 
      placebo, N=206) and 413 (lubiprostone, N=209; placebo, N=204) patients, 
      respectively. The mean (standard deviation) age was 50.4 (10.9) years; most 
      patients were female (64.4%) and white (77.7%). Changes from baseline in SBM 
      frequency rates were significantly higher at week 8 (P=0.005) and overall 
      (P=0.004) in patients treated with lubiprostone compared with placebo. Pairwise 
      comparisons showed significantly greater overall improvement for abdominal 
      discomfort (P=0.047), straining (P<0.001), constipation severity (P=0.007), and 
      stool consistency (P<0.001) with lubiprostone compared with placebo. Moreover, 
      patients rated the effectiveness of lubiprostone as significantly (P<0.05) better 
      than placebo for 11 of 12 weeks. The most common treatment-related adverse events 
      (AEs) with lubiprostone and placebo were nausea (16.8% vs 5.8%, respectively), 
      diarrhea (9.6% vs 2.9%), and abdominal distention (8.2% vs 2.4%). No 
      lubiprostone-related serious AEs occurred. CONCLUSION: Lubiprostone effectively 
      relieved OIC and associated signs and symptoms and was well tolerated in patients 
      with chronic noncancer pain (http://clinicaltrials.gov/ct2/show/NCT00595946).
CI  - (c) 2014 The Authors. Pain Medicine published by Wiley Periodicals, Inc. on behalf 
      of American Academy of Pain Medicine.
FAU - Cryer, Byron
AU  - Cryer B
AD  - Department of Internal Medicine, Digestive and Liver Diseases, University of 
      Texas Southwestern Medical School, Dallas, Texas, USA; Gastroenterology and 
      Hepatology, Veterans Affairs North Texas Health Care System, Dallas, Texas, USA.
FAU - Katz, Seymour
AU  - Katz S
FAU - Vallejo, Ricardo
AU  - Vallejo R
FAU - Popescu, Anca
AU  - Popescu A
FAU - Ueno, Ryuji
AU  - Ueno R
LA  - eng
SI  - ClinicalTrials.gov/NCT00595946
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140409
PL  - England
TA  - Pain Med
JT  - Pain medicine (Malden, Mass.)
JID - 100894201
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Chloride Channel Agonists)
RN  - 7662KG2R6K (Lubiprostone)
RN  - F5TD010360 (Alprostadil)
SB  - IM
MH  - Alprostadil/*analogs & derivatives/therapeutic use
MH  - Analgesics, Opioid/*adverse effects
MH  - Chloride Channel Agonists/*therapeutic use
MH  - Chronic Pain/*drug therapy
MH  - Constipation/*chemically induced/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Lubiprostone
MH  - Male
MH  - Middle Aged
PMC - PMC4282321
OTO - NOTNLM
OT  - Bowel Movement
OT  - ClC-2
OT  - Opioid
OT  - Opioid-Induced Constipation
OT  - Placebo-Controlled Trial
OT  - Prostone
EDAT- 2014/04/11 06:00
MHDA- 2015/11/05 06:00
CRDT- 2014/04/11 06:00
PHST- 2014/04/11 06:00 [entrez]
PHST- 2014/04/11 06:00 [pubmed]
PHST- 2015/11/05 06:00 [medline]
AID - 10.1111/pme.12437 [doi]
PST - ppublish
SO  - Pain Med. 2014 Nov;15(11):1825-34. doi: 10.1111/pme.12437. Epub 2014 Apr 9.