Lubiprostone safety profile comparable in children, adults with PFC
Lubiprostone was not significantly more effective compared with placebo in children or adolescents with pediatric functional constipation; however, the safety profile was similar to that in adults, according to study results.
“In summary, the results of this analysis of two phase 3 studies showed that the overall safety profile of lubiprostone in this population was comparable to that observed in adult patients with chronic constipation,” Marc A. Benninga, pediatric gastroenterologist from Emma Children’s Hospital, Amsterdam University Medical Center, the Netherlands, and colleagues wrote. “However, lubiprostone did not demonstrate statistically significant effectiveness over placebo in treating [pediatric functional constipation (PFC)] in children and adolescents aged [6 to 17] years.”
Benninga and colleagues performed a phase 3, multicenter, randomized, double-blind, placebo-controlled, 12-week study of lubiprostone 12 µg twice daily and 24 µg twice daily in patients with PFC. The study comprised 606 patients, with 202 receiving placebo and 404 patients receiving lubiprostone.
Then, a second study was performed, an open-label extension for those who completed the placebo-controlled phase.
According to researchers, lubiprostone doses were based on a patient’s weight. Efficacy was evaluated based on Study One. Overall spontaneous bowel movement served as the primary endpoint.
Results showed there was no significant difference in the spontaneous bowel movement overall between lubiprostone and placebo groups (18.5% vs 14.4%). Investigators noted both doses of lubiprostone were well tolerated.
The safety profile was consistent with results from adult studies.
“Accordingly, the FDA-approved labeling for lubiprostone has been updated to state that the safety and effectiveness of lubiprostone have not been established in pediatric patients [younger than 6] years of age, and that effectiveness has not been established in pediatric patients [6 years or older],” the researchers wrote.