Key finding: 606 patients were randomized to treatment (placebo: n=202; lubiprostone: n=404). No statistically significant difference in overall SBM (spontaneous bowel movement) response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P=.2245).
A recent open-label study of lubiprostone examined its use in children younger than 18 years (2007-2008) at 22 U.S. centers (JPGN 2014; 58: 283-91).
Lubiprostone (Amitiza) activates chloride-channel protein-2 in the gastrointestinal epithelium and promotes secretion of chloride ions and fluid. This results in more frequent bowel movements (BMs) and improved motility. To determine its safety and effectiveness in the pediatric population, the investigators enrolled 127 patients (124 were treated and analyzed and 109 completed the 4-week study). After a 2-week observation period, several doses of lubiprostone were compared: 12 μg QD, 12 μg BID, 24 μg BID. There was no placebo group. The mean age of the participants was 10.2 years.
Mean spontaneous BM frequency increased from baseline: 3.1/week versus 1.5/week. Overall, at each week in treatment ≥ 43% achieved ≥ 3 spontaneous BMs/week.
62% experienced a spontaneous BM within 48 hours of starting treatment.
Common adverse reactions: Nausea (18.5%), vomiting (12.1%), diarrhea (8.1%), abdominal pain (7.3%) and headache (5.6%). Overall, 65% of patients experienced ≥ 1 adverse effect and this was highest (78%) in the subset of patients receiving the highest dosage
Bottomline: Current guidelines recommend osmotic agents like polyethylene glycol (PEG) (Miralax) as first-line treatment. This short-term study shows lubiprostone may be an alternative in nonresponders, though more data on long-term outcomes are needed.