Part of the results of the study has previously been presented at the British Society of Gastroenterology Annual General Meeting, 14–17 March 2011 (same analysis but in a slightly different study population): Kerstens R, Vandeplassche L, Dubois D, Wouters L. Response of chronic constipation symptoms to prucalopride treatment and relationship with patient satisfaction. Gut 2011; 60 (Suppl. 1): A159.
Effect of prucalopride on symptoms of chronic constipation
Article first published online: 20 SEP 2013
© 2013 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Neurogastroenterology & Motility
Volume 26, Issue 1, pages 21–27, January 2014
How to Cite
Tack, J., Stanghellini, V., Dubois, D., Joseph, A., Vandeplassche, L. and Kerstens, R. (2014), Effect of prucalopride on symptoms of chronic constipation. Neurogastroenterology & Motility, 26: 21–27. doi: 10.1111/nmo.12217
- Issue published online: 13 DEC 2013
- Article first published online: 20 SEP 2013
- Manuscript Accepted: 29 JUL 2013
- Manuscript Received: 28 JAN 2013
- Janssen Research Foundation
- Shire-Movetis NV
- abdominal discomfort;
- chronic constipation;
- painful bowel movements;
Prucalopride is a 5-HT4 receptor agonist with gastrointestinal prokinetic activities. This integrated analysis of data from three 12-week, double-blind trials evaluated the effect of prucalopride 2 mg q.d. on common constipation symptoms in women in whom laxatives had failed to provide adequate relief. The effect of prucalopride on bowel function was outside the scope of the analysis and has been described elsewhere.
Women with self-reported inadequate relief from laxatives and included in the prucalopride 2 mg or placebo arm of the trials were selected for analysis. Symptom severity was determined with the Patient Assessment of Constipation Symptoms (PAC–SYM) questionnaire. Observed changes from baseline in individual item scores were also evaluated by calculating Cohen's D effect sizes using baseline standard deviation (SD) (>0.2–0.5, >0.5–0.8 and >0.8 for small, moderate and large effects, respectively).
Data were analyzed for 936 women. The proportion of women with a PAC-SYM severity score >2 at baseline was 50.0% for abdominal symptoms, 71.4% for stool symptoms, and 15.5% for rectal symptoms. Excluding the women without presence of a symptom at baseline from the effect size calculations showed that prucalopride 2 mg had a large effect (>0.8) on all PAC-SYM items, including abdominal pain, abdominal discomfort, bloating, straining, and painful bowel movements. For abdominal symptoms and stool symptoms, effect sizes with prucalopride 2 mg were 1.3–2.3 times larger than those with placebo.
Conclusions & Inferences
Prucalopride 2 mg q.d. for 12 weeks alleviates common constipation symptoms in women in whom laxatives had failed to provide adequate relief.