A recent study has shown that Lubiprostone does not seem to have any favorable effect in the treatment of pediatric functional constipation (PFC); however, the drug has a safety profile similar to that reported in adults.
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What is pediatric functional constipation?
Pediatric functional constipation
is term that describes all children in whom constipation does not have an
organic etiology. PFC is prevalently the outcome or the result of withholding
of feces in a child who wants to do away with painful defecation.
Study entailed two parts. For the first part, there’s
a total of 606 patients with PFC with age range 6 – 17 years old who were
randomized to receive Lubiprostone at either 12 or 24 mcg BID or placebo for 12
weeks. On the second part, there was an open-label extension of part 1.
For both parts, Lubiprostone doses were based on
patient weight. The drugs efficacy was assessed primarily based on the results
of the first part, with a primary endpoint of overall spontaneous bowel
movement (SBM) response (increase of >1 SBM/week vs baseline and >3
SBMs/week for >9 weeks, including 3 of the final 4 weeks).
Findings show no statistically significant difference in
overall SBM response rate between the Lubiprostone and placebo groups. The
endpoint was attained in 18.5% of patients in the active treatment group vs
14.4% of those who received placebo.
The 12- and 24- mcg BID doses of Lubiprostone were
well tolerated in the double-blind and extension parts. Safety profile was also
consistent with that observed in the adult studies.
Source: Clin Gastroenterol Hepatol
2021;doi:10.1016/j.cgh.2021.04.005