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Polyethylene Glycol 3350 with Electrolytes for Constipation.

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eMediNexus    10 April 2018

A new study published in the Journal of Pediatric Gastroenterology and Nutrition investigated the non-inferiority of PEG3350 with electrolytes (PEG3350 + E) when compared to PEG4000 without electrolytes (PEG4000). This was a double-blind trial, which included children aged 0.5 to 16 years with constipation, defined as a defecation frequency of <3 times per week, who were randomized to receive either PEG3350 + E or PEG4000. Total sum score (TSS) was the sum of the severity of five constipation symptoms rated on a 4-point scale (0-3). Here, treatment success was defined as a defecation frequency of ≥3 per week with <1 episode of fecal incontinence. Overall, 82 pediatric patients completed the study. The results displayed that the mean reduction in TSS was -3.81 and -3.74, for PEG3350 + E and PEG4000, respectively. Daily sachet use was as follows: 0-2 years – 0.4 to 2.3 and 0.9 to 2.1; 2-4 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; and 8-16 years – 0.6 to 3.7 and 1.0 to 3.7, in PEG3350 + E and PEG4000, respectively. Additionally, treatment success after 52 weeks was achieved in 50% and 45% of the children in PEG3350 + E and PEG4000 groups, respectively. Meanwhile, the rates of adverse events were equivalent between groups, and no drug-related serious adverse events were reported. From the analysis of secondary outcomes it was stated that PEG3350 + E and PEG4000 had comparable efficacy and safety.

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