Safety and efficacy of linaclotide in treating functional constipation in paediatric patients

According to a recent study, linaclotide has proven to be an effective and well-tolerated remedy for functional constipation in pediatric patients. This study’s findings were published in the journal, Lancet. Gastroenterology & hepatology.

In this double-blind, randomised,  placebo-controlled, phase 3 study, patients aged 6-17 years were randomly assigned to receive either oral linaclotide 72 μg [n=166] or placebo [n=164] once daily for 12 weeks. The study's primary efficacy endpoint was the change from baseline (CFB) in the frequency rate of spontaneous bowel movements (SBM) per week over a twelve-week period. The change from baseline in stool consistency during the treatment period was the secondary efficacy endpoint. Efficacy and safety were analyzed in all patients who received at least one dose of the study intervention.

The mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) with placebo and 1·16 SBMs per week (0·83) with linaclotide at baseline. This rate increased to 2·29 SBMs per week (1·99) with placebo and 3·41 SBMs per week (2·76) with linaclotide during the intervention. Patients treated with linaclotide demonstrated a significant increase in SBM frequency [least-squares mean (LSM) CFB 2·22 SBMs per week (SE 0·19)] compared to those on placebo [LSM CFB 1·05 SBMs per week (0·19)]. Additionally, linaclotide demonstrated a notable improvement in stool consistency compared to the placebo group [LSM CFB 1.11 (SE 0.08) versus 0.69 (0.08)]. Based on the above results, it can be concluded that linaclotide is an efficacious and well-tolerated treatment for functional constipation in paediatric patients.