Digestive Disease Week 2023

Linaclotide—a guanylate cyclase-C agonist—was efficacious and safe in paediatric patients with functional constipation, according to a phase 3 randomised trial presented by Carlo Di Lorenzo (Columbus, OH, USA). 330 patients aged 6–17 years who met modified Rome III criteria were randomly assigned (1:1) to receive once-daily oral placebo or linaclotide 72 μg—a drug approved to treat constipation in adults—for 12 weeks. Linaclotide significantly improved spontaneous bowel movement (SBM) frequency rate—the primary outcome—compared with placebo (least square means 2·220 SBMs per week [SE 0·187] vs 1·050 SBMs per week [0·187]; difference 1·170 SBMs per week [95% CI 0·651–1·689]; p<0·0001), as well as stool consistency. Both groups had similar proportions of patients with adverse events. The most common treatment-emergent adverse events (TEAEs) were diarrhoea (seven [4%] of 164 patients in the linaclotide group vs three [2%] of 164 patients in the placebo group) and COVID-19 (four [2%] vs five [3%]).