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Long‐Term Safety and Efficacy of Lubiprostone in Opioid‐induced Constipation in Patients with Chronic Noncancer Pain
Author(s) -
Spierings Egilius L.H.,
Rauck Richard,
Brewer Randall,
Marcuard Stefano,
Vallejo Ricardo
Publication year - 2016
Publication title -
pain practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.899
H-Index - 58
eISSN - 1533-2500
pISSN - 1530-7085
DOI - 10.1111/papr.12347
Subject(s) - lubiprostone , medicine , constipation , opioid , chronic pain , term (time) , chronic constipation , intensive care medicine , anesthesia , physical therapy , physics , receptor , quantum mechanics
Abstract 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 μg twice daily for up to 9 months. OIC was defined as < 3 spontaneous bowel movements ( SBM s)/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 ( AE s), most commonly nausea (5.0%), diarrhea (4.6%), headache (1.6%), and vomiting (1.4%). No treatment‐related serious AE s 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.