The present trial included adults with chronic idiopathic constipation and randomized them to polyethylene glycol 3350 17 g (n = 204) or placebo (n = 100) once daily for 24 weeks. It performed Post hoc analyses using the US Food and Drug Administration endpoint (≥3 complete spontaneous bowel movements/week and an increase of ≥1 complete spontaneous bowel movement/week from baseline for ≥9/12 weeks, including 3 of the last four weeks) along with additional efficacy and safety outcomes.

The study found-

• The proportion of patients meeting the new endpoint was significantly higher with polyethylene glycol 3350 than with placebo (42% vs. 13%).
• Reductions in the mean number of hard/lumpy stools/week (-2.1 vs. -0.9) and the weekly mean five-point cramping rating (-0.3 vs. -0.1) were in significant favor of polyethylene glycol 3350.
• The proportion of subjects with gastrointestinal adverse events declined markedly after the first week of treatment in the polyethylene glycol 3350 group.

Using the current US Food and Drug Administration-recommended responder definition and other secondary outcomes, this study shows that once-daily polyethylene glycol 3350 has substantial and sustained efficacy and safety over 24 weeks in patients with chronic idiopathic constipation.

Menees SB, Lembo AJ, Chey WD. Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints. Can J Gastroenterol Hepatol. 2022 Sep 9;2022:3533504. doi: 10.1155/2022/3533504.