Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints

Background & Aims. The efficacy and safety of polyethylene glycol 3350 for chronic idiopathic constipation have been demonstrated in randomized controlled trials. A new US Food and Drug Administration-recommended primary efficacy endpoint for evaluating chronic idiopathic constipation prompted o...

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Main Authors: Stacy B. Menees, Anthony J. Lembo, William D. Chey
Format: Article
Language:English
Published: Wiley 2022-01-01
Series:Canadian Journal of Gastroenterology and Hepatology
Online Access:http://dx.doi.org/10.1155/2022/3533504
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author Stacy B. Menees
Anthony J. Lembo
William D. Chey
author_facet Stacy B. Menees
Anthony J. Lembo
William D. Chey
author_sort Stacy B. Menees
collection DOAJ
description Background & Aims. The efficacy and safety of polyethylene glycol 3350 for chronic idiopathic constipation have been demonstrated in randomized controlled trials. A new US Food and Drug Administration-recommended primary efficacy endpoint for evaluating chronic idiopathic constipation prompted our reevaluation of previously reported clinical data with polyethylene glycol 3350. Methods. This multicenter, double-blind, placebo-controlled, parallel-group trial included adults with chronic idiopathic constipation randomized to polyethylene glycol 3350 17 g (n = 204) or placebo (n = 100) once daily for 24 weeks. Post hoc analyses were performed 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 4 weeks) along with additional efficacy and safety outcomes. Results. The proportion of patients meeting the new endpoint was significantly higher with polyethylene glycol 3350 vs placebo (42% vs 13%; P<0.0001). Reductions in the mean number of hard/lumpy stools/week (–2.1 vs –0.9; P=0.0014) and the weekly mean five-point cramping rating (–0.3 vs –0.1; P=0.0272) also significantly favored polyethylene glycol 3350. The proportion of subjects with gastrointestinal adverse events decreased markedly after the first week of treatment in the polyethylene glycol 3350 group. Conclusion. Using the current US Food and Drug Administration-recommended responder definition and other secondary outcomes, once-daily polyethylene glycol 3350 demonstrated substantial and sustained efficacy and safety over 24 weeks in patients with chronic idiopathic constipation. Trial Registration. The original trial was registered with https://clinicaltrials.gov Trial: NCT00153153.
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spelling doaj-art-4035290d48974db582f9bca60748466d2025-02-03T01:22:59ZengWileyCanadian Journal of Gastroenterology and Hepatology2291-27972022-01-01202210.1155/2022/3533504Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA EndpointsStacy B. Menees0Anthony J. Lembo1William D. Chey2Division of Gastroenterology & HepatologyDivision of GastroenterologyDivision of GastroenterologyBackground & Aims. The efficacy and safety of polyethylene glycol 3350 for chronic idiopathic constipation have been demonstrated in randomized controlled trials. A new US Food and Drug Administration-recommended primary efficacy endpoint for evaluating chronic idiopathic constipation prompted our reevaluation of previously reported clinical data with polyethylene glycol 3350. Methods. This multicenter, double-blind, placebo-controlled, parallel-group trial included adults with chronic idiopathic constipation randomized to polyethylene glycol 3350 17 g (n = 204) or placebo (n = 100) once daily for 24 weeks. Post hoc analyses were performed 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 4 weeks) along with additional efficacy and safety outcomes. Results. The proportion of patients meeting the new endpoint was significantly higher with polyethylene glycol 3350 vs placebo (42% vs 13%; P<0.0001). Reductions in the mean number of hard/lumpy stools/week (–2.1 vs –0.9; P=0.0014) and the weekly mean five-point cramping rating (–0.3 vs –0.1; P=0.0272) also significantly favored polyethylene glycol 3350. The proportion of subjects with gastrointestinal adverse events decreased markedly after the first week of treatment in the polyethylene glycol 3350 group. Conclusion. Using the current US Food and Drug Administration-recommended responder definition and other secondary outcomes, once-daily polyethylene glycol 3350 demonstrated substantial and sustained efficacy and safety over 24 weeks in patients with chronic idiopathic constipation. Trial Registration. The original trial was registered with https://clinicaltrials.gov Trial: NCT00153153.http://dx.doi.org/10.1155/2022/3533504
spellingShingle Stacy B. Menees
Anthony J. Lembo
William D. Chey
Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints
Canadian Journal of Gastroenterology and Hepatology
title Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints
title_full Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints
title_fullStr Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints
title_full_unstemmed Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints
title_short Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints
title_sort polyethylene glycol 3350 in the treatment of chronic idiopathic constipation post hoc analysis using fda endpoints
url http://dx.doi.org/10.1155/2022/3533504
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