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Medline ® Abstract for Reference 80

of 'Chronic functional constipation and fecal incontinence in infants and children: Treatment'

Lubiprostone for the treatment of functional constipation in children.
Hyman PE, Di Lorenzo C, Prestridge LL, Youssef NN, Ueno R
J Pediatr Gastroenterol Nutr. 2014 Mar;58(3):283-91.
OBJECTIVES: Pediatric functional constipation is common; effective, easily administered treatment options are limited. Lubiprostone is an oral chloride channel protein-2 activator that stimulates gastrointestinal fluid secretion, softens stools, and facilitates bowel movements (BMs). We evaluated the safety and effectiveness of lubiprostone in children and adolescents with functional constipation.
METHODS: Patients≥12 kg, 17 years or younger, and with<3 spontaneous BMs (SBMs; ie, BMs that did not occur within 24 hours of rescue medication use) per week were enrolled at 22 US general pediatric and pediatric gastroenterology centers (January 2007-October 2008). Patients received 4 weeks of open-label lubiprostone at doses of 12μg once daily (QD), 12μg twice daily (BID), or 24μg BID based on age and weight. The primary endpoint was SBM frequency during week 1 versus baseline.
RESULTS: Of 127 enrolled patients, 124 were treated and analyzed (12μg QD, n = 27; 12μg BID, n = 65; 24μg BID, n = 32), and 109 completed the study. The mean age of treated patients was 10.2 years (range 3-17 years); 65 were boys. Mean SBM frequency significantly increased compared with baseline at week 1 (3.1 vs. 1.5 SBMs/week, P < 0.0001). SBM frequency was improved significantly from baseline overall (P < 0.0001) and for individual dose groups (P ≤ 0.0062) during weeks 2, 3, and 4. Common (≥5%) adverse events included nausea (18.5%), vomiting (12.1%), diarrhea (8.1%), abdominal pain (7.3%), and headache (5.6%). Two patients experienced serious adverse events (unrelated abdominal pain; unrelated sickle cell crisis).
CONCLUSIONS: Lubiprostone was efficacious and well tolerated in children and adolescents with functional constipation.
*Louisiana State University and Children's Hospital, New Orleans, LA†Nationwide Children's Hospital, Columbus, OH‡Boys Town National Research Hospital, Boys Town, NE§Digestive Healthcare Center, Hillsborough, NJ ||Sucampo Pharmaceuticals, Zug, Switzerland and Bethesda, MD.