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Lubiprostone for the treatment of functional constipation in children
Paul E Hyman1, Carlo Di Lorenzo, Laurel L Prestridge
1*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.
Insights
Lubiprostone effectively treats pediatric functional constipation by increasing spontaneous bowel movements. This medication is safe and well-tolerated in children and adolescents, offering a new treatment option.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Trials
Background:
- Pediatric functional constipation is a prevalent condition with limited treatment options.
- Lubiprostone, a chloride channel protein-2 activator, enhances intestinal fluid secretion and stool softening.
- This study assessed lubiprostone's safety and efficacy in pediatric patients.
Purpose of the Study:
- To evaluate the safety and effectiveness of lubiprostone in children and adolescents with functional constipation.
- To determine optimal dosing regimens for lubiprostone in this population.
- To assess the impact of lubiprostone on spontaneous bowel movement frequency.
Main Methods:
- A 4-week, open-label study enrolled pediatric patients (17 years or younger) with functional constipation.
- Patients received lubiprostone at doses of 12 μg once daily, 12 μg twice daily, or 24 μg twice daily.
- The primary endpoint was the change in spontaneous bowel movement frequency from baseline during the first week of treatment.
Main Results:
- Lubiprostone significantly increased spontaneous bowel movement frequency at week 1 (3.1 vs. 1.5 SBMs/week, P < 0.0001).
- Improvements in bowel movement frequency were sustained throughout the 4-week study period across all dose groups.
- Common adverse events included nausea, vomiting, and abdominal pain; serious adverse events were rare.
Conclusions:
- Lubiprostone demonstrated efficacy in treating functional constipation in pediatric patients.
- The medication was generally well-tolerated, with a manageable safety profile.
- Lubiprostone represents a valuable therapeutic option for pediatric functional constipation.
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 12 μg once daily (QD), 12 μg twice daily (BID), or 24 μg 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 (12 μg QD, n = 27; 12 μg BID, n = 65; 24 μg 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.
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