PMID- 26328775
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 1533-2500 (Electronic)
IS  - 1530-7085 (Linking)
VI  - 16
IP  - 8
DP  - 2016 Nov
TI  - Long-Term Safety and Efficacy of Lubiprostone in Opioid-induced Constipation in 
      Patients with Chronic Noncancer Pain.
PG  - 985-993
LID - 10.1111/papr.12347 [doi]
AB  - BACKGROUND: Chronic opioid analgesic use often causes opioid-induced constipation 
      (OIC). This open-label extension study evaluated the safety and efficacy of 
      lubiprostone, a chloride channel (ClC-2) activator, for treatment of OIC in 
      patients with chronic noncancer pain. METHODS: Adults with OIC were enrolled from 
      two 12-week, placebo-controlled, double-blind studies and received lubiprostone 
      24 mug twice daily for up to 9 months. OIC was defined as < 3 spontaneous bowel 
      movements (SBMs)/week during the 2-week baseline period, of which >/= 25% were 
      characterized by hard to very hard stool consistency, subjectively incomplete 
      evacuation, and/or moderate or worse straining. Inclusion criteria required 
      consistent treatment with full opioid agonists >/= 30 days prior to screening and 
      throughout the study. RESULTS: All 439 patients who received lubiprostone were 
      analyzed for safety and efficacy. Overall, 24.6% of patients reported 
      treatment-related adverse events (AEs), most commonly nausea (5.0%), diarrhea 
      (4.6%), headache (1.6%), and vomiting (1.4%). No treatment-related serious AEs 
      were reported. Nausea and diarrhea each led to study discontinuation in 5 
      patients (1.1%); 2 cases each of nausea and diarrhea were rated as severe. Rescue 
      medication usage decreased from month 1 (33.0%) to month 9 (18.6%). Mean weekly 
      SBM frequency (1.4) was significantly increased from baseline at all months 
      (P < 0.001, range 4.9 to 5.3). Straining, abdominal bloating, abdominal 
      discomfort, stool consistency, constipation severity, and bowel habit regularity 
      were significantly improved from baseline at all months (P < 0.001). CONCLUSIONS: 
      Lubiprostone treatment was well tolerated and improved symptoms and signs of OIC 
      in this 9-month, open-label study of patients with chronic noncancer pain.
CI  - (c) 2015 World Institute of Pain.
FAU - Spierings, Egilius L H
AU  - Spierings ELH
AD  - Headache & Face Pain Program, Tufts Medical Center, and Craniofacial Pain Center, 
      Tufts University School of Dental Medicine, Boston, Massachusetts, U.S.A.
FAU - Rauck, Richard
AU  - Rauck R
AD  - The Carolinas Pain Institute, Winston-Salem, North Carolina, U.S.A.
FAU - Brewer, Randall
AU  - Brewer R
AD  - Duke University Medical Center, Durham, North Carolina, U.S.A.
FAU - Marcuard, Stefano
AU  - Marcuard S
AD  - Carolina Digestive Diseases, Greenville, North Carolina, U.S.A.
FAU - Vallejo, Ricardo
AU  - Vallejo R
AD  - Millennium Pain Center, Bloomington, Illinois, U.S.A.
LA  - eng
PT  - Journal Article
DEP - 20150829
PL  - United States
TA  - Pain Pract
JT  - Pain practice : the official journal of World Institute of Pain
JID - 101130835
OTO - NOTNLM
OT  - ClC-2
OT  - bowel dysfunction
OT  - bowel movement
OT  - chloride channel activator
OT  - constipation
OT  - lubiprostone
OT  - opioid-induced constipation
OT  - pain management
EDAT- 2015/09/04 06:00
MHDA- 2015/09/04 06:01
CRDT- 2015/09/03 06:00
PHST- 2015/03/12 00:00 [received]
PHST- 2015/06/18 00:00 [accepted]
PHST- 2015/09/04 06:00 [pubmed]
PHST- 2015/09/04 06:01 [medline]
PHST- 2015/09/03 06:00 [entrez]
AID - 10.1111/papr.12347 [doi]
PST - ppublish
SO  - Pain Pract. 2016 Nov;16(8):985-993. doi: 10.1111/papr.12347. Epub 2015 Aug 29.