TY - JOUR
T1 - A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain
AU - Cryer, Byron
AU - Katz, Seymour
AU - Vallejo, Ricardo
AU - Popescu, Anca
AU - Ueno, Ryuji
N1 - Publisher Copyright:
© 2014 The Authors. Pain Medicine published by Wiley Periodicals, Inc. on behalf of American Academy of Pain Medicine.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - 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 24mcg 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).
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 24mcg 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).
KW - Bowel Movement
KW - ClC-2
KW - Opioid
KW - Opioid-Induced Constipation
KW - Placebo-Controlled Trial
KW - Prostone
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UR - http://www.scopus.com/inward/citedby.url?scp=84911991195&partnerID=8YFLogxK
U2 - 10.1111/pme.12437
DO - 10.1111/pme.12437
M3 - Article
C2 - 24716835
AN - SCOPUS:84911991195
SN - 1526-2375
VL - 15
SP - 1825
EP - 1834
JO - Pain Medicine (United States)
JF - Pain Medicine (United States)
IS - 11
ER -