Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating

Kyle Staller, Jimmy Hinson, René Kerstens, William Spalding, Anthony Lembo, Kyle Staller, Jimmy Hinson, René Kerstens, William Spalding, Anthony Lembo

Abstract

Introduction: This post hoc analysis evaluated the effect of prucalopride on abdominal bloating in participants with chronic idiopathic constipation (CIC) who had moderate to very severe bloating at baseline.

Methods: Data from 6 phase 3/4 studies of prucalopride in participants with CIC were pooled. Abdominal bloating was assessed weekly using a 5-point scale (0-4).

Results: The proportion of bloating responders (≥1-point improvement in abdominal bloating score at week 12) was higher in participants treated with prucalopride (62.1%) vs placebo (49.6%).

Discussion: The prucalopride arm had a higher proportion of bloating responders vs placebo in this study population.

Trial registration: ClinicalTrials.gov NCT00488137 NCT00483886 NCT00485940 NCT01147926 NCT01116206 NCT01424228.

Conflict of interest statement

Guarantor of the article: Kyle Staller, MD, MPH.

Specific author contributions: K.S.: contributed to the planning and conduct of the analysis, interpretation of the data and drafting of the manuscript, and has approved the final submitted draft. J.H.: contributed to the planning and conduct of the analysis, interpretation of the data and drafting of the manuscript, and has approved the final submitted draft. R.K.: contributed to the planning and conduct of the analysis, interpretation of the data and drafting of the manuscript, and has approved the final submitted draft. W.S.: contributed to the planning and conduct of the analysis, interpretation of the data and drafting of the manuscript, and has approved the final submitted draft. A.L.: contributed to the planning and conduct of the analysis, interpretation of the data and drafting of the manuscript, and has approved the final submitted draft.

Financial support: The clinical trials included in this analysis were funded by Shire International GmbH, Johnson and Johnson and Movetis, and Shire-Movetis NV or Janssen Research and Development. This analysis was funded by Shire Human Genetic Therapies, Inc., a Takeda company.

Potential competing interests: K. Staller has received consultancy fees from Arena, Boston Pharmaceuticals, Gelesis, and Synergy; has received speaker and consultancy fees from Shire, a Takeda company; and has received research fees from AstraZeneca, Gelesis, Ironwood, and Urovant. J. Hinson is an employee of Takeda Development Centre Americas, Inc., and a stockholder of Takeda Pharmaceutical Company Limited. R. Kerstens is an employee of Orion Statistical Consulting BV, which received funding from Shire Human Genetic Therapies, Inc., a Takeda company, for this analysis. William Spalding is an employee of Takeda Development Centre Americas, Inc, and a stockholder of Takeda Pharmaceutical Company Limited. Anthony Lembo has received research funding and consultancy fees from Shire, a Takeda company, and Takeda, Arena, Ardelyx, Ironwood, Vibrant, Mylan, Bayer, Gelesis, and Orphomed.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.

Figures

Figure 1.
Figure 1.
The proportion of abdominal bloating responders (Responders were defined as participants with an improvement of ≥1 point in abdominal bloating score from baseline to week 12, as measured by the PAC-SYM questionnaire) at week 12 according to (a) treatment arm, (b) sex, (c) age, (d) baseline severity of bloating (baseline bloating severity was defined according to the PAC-SYM questionnaire), and (e) main complaint at baseline. PAC-SYM, Patient Assessment of Constipation Symptoms.
Figure 2.
Figure 2.
Percentage change in abdominal bloating score (bloating severity was measured on a 5-point scale [0–4] at baseline and weeks 2, 4, 8, and 12 using the PAC-SYM questionnaire) over time in participants with CIC who had moderate to very severe abdominal bloating at baseline. CIC, chronic idiopathic constipation; PAC-SYM, Patient Assessment of Constipation Symptoms.
Figure 3.
Figure 3.
Change from baseline to week 12 in PAC-QOL scores in abdominal bloating responders (responders were defined as participants with an improvement of ≥1 point in abdominal bloating score from baseline to week 12, as measured by the PAC-SYM questionnaire) and nonresponders in pooled data from 6 trials and by individual clinical trial. PAC-SYM, Patient Assessment of Constipation Symptoms; PAC-QOL, Patient Assessment of Constipation Quality of Life.

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