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Lubiprostone Does Not Have Favorable Effect in Treating Pediatric Functional Constipation, Study Shows

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.

Photo: Pediatric Functional Constipation | InStyleHealth

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

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