Objective: The long-term efficacy and safety of polyethylene glycol (PEG) in constipated children are unknown, and a head-to-head comparison of the different PEG formulations is lacking. We aimed to investigate noninferiority of PEG3350 with electrolytes (PEG3350+E) compared to PEG4000 without electrolytes (PEG4000). Methods: In this double-blind trial, children aged 0.5 to 16 years with constipation, defined as a defecation frequency of <3 times per week, were randomized to receive either PEG3350+E or PEG4000. Primary outcomes were change in total sum score (TSS) at week 52 compared to baseline, and dose range determination. TSS was the sum of the severity of 5 constipation symptoms rated on a 4-point scale (0-3). Noninferiority margin was a difference in TSS of ≤1.5 based on a 95%-confidence interval [CI]. Treatment success was defined as a defecation frequency of ≥3 per week with <1 episode of fecal incontinence. Results: Ninety-seven subjects were included, of whom 82 completed the study.Mean reduction inTSSwas-3.81 (95%CI:-4.96 to-2.65) and-3.74 (95%CI: -5.08 to -2.40), for PEG3350+E and PEG4000, respectively. Noninferiority criteria were not met (maximum difference between groups: -1.81 to 1.68).Daily sachet usewas: 0 to 2 years: 0.4 to 2.3 and 0.9 to 2.1; 2 to 4 years: 0.1 to 3.5 and 1.2 to 3.2; 4 to 8 years: 1.1 to 2.8 and 0.7 to 3.8; 8 to 16 years 0.6 to 3.7 and 1.0 to 3.7, in PEG3350+E and PEG4000, respectively. Treatment success after 52 weeks was achieved in 50% and 45% of children, respectively (P=0.69). Rates of adverse events were similar between groups, and no drug-related serious adverse events occurred. Conclusions: Noninferiority regarding long-term constipation-related symptoms of PEG3350+E compared to PEG4000 was not demonstrated. However, analysis of secondary outcomes suggests similar efficacy and safety of these agents.
|Number of pages||6|
|Journal||Journal of Pediatric Gastroenterology and Nutrition|
|Publication status||Published - 1 Jan 2018|