Fakty Miami
A newly approved option for pediatric patients with functional constipation significantly increased the frequency of bowel movements and improved other burdensome symptoms as well, according to a pivotal phase III trial.
Among children ages 6 years and older, linaclotide (Linzess) doubled the increase in weekly spontaneous bowel movements (SBMs) over 12 weeks compared with placebo (least squares mean [LSM] change 2.22 vs 1.05, P<0.0001).
Fully 57% of patients in the treatment group experienced an SBM within the first 48 hours of receiving the drug, reported Julie Khlevner, MD, of Columbia University in New York City, and colleagues in Lancet Gastroenterology & Hepatology.
Linaclotide, a guanylate cyclase C agonist, was approved by the FDA in June 2023 for pediatric patients ages 6 years and up based on initial results from this multicenter trial as well as data from trials in adults with chronic idiopathic constipation.
“In the present study, the additional data showing improvements in stool consistency, complete SBM frequency, and straining suggest that linaclotide might address a range of symptoms associated with functional constipation in pediatric patients aged 6-17 years, not just SBM frequency,” Khlevner’s group wrote.
“Functional constipation symptoms are burdensome,” the researchers explained, “affecting quality of life and leading to absenteeism from school, and can also affect families.”
Stool consistency, as measured with the pediatric Bristol Stool Form Scale and reported by patients or their caregivers, significantly improved from baseline in the treatment group compared with placebo (LSM difference of 0.42 on the 7-point scale, P=0.0001).
The frequency of complete SBMs (an SBM associated with a sense of complete evacuation) was also significantly improved from baseline in the treatment group compared with placebo (LSM diffe