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      Use of Prucalopride for Chronic Constipation: A Systematic Review and Meta-analysis of Published Randomized, Controlled Trials

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          Abstract

          This article highlights the role of prucalopride in the management of chronic constipation based upon the principles of meta-analysis using data reported in the published randomized, controlled trials. Sixteen randomized, controlled trials on 3943 patients reported the effectiveness of prucalopride in patients with chronic constipation. Prucalopride successfully increased the frequency of spontaneous bowel movements per week in all variable doses of 1 mg (standardized mean difference [SMD], 0.42 [95% CI, 0.18–0.66; P = 0.006]), 2 mg (SMD, 0.34 [95% CI, 0.11–0.56; P = 0.003]), and 4 mg (SMD, 0.33 [95% CI, 0.22–0.44; P = 0.00001]). The risks of adverse events or side effects such as headache, abdominal cramps, excessive flatulence, dizziness, diarrhea, and rash were higher (odds ratio, 1.70 [95% CI, 1.27 to −2.27; P = 0.0004]) in prucalopride group. Prucalopride is clinically a beneficial pharmacotherapy for chronic constipation and its routine use may be considered in patients with chronic simple laxative-resistant constipation.

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          Rome III: New standard for functional gastrointestinal disorders.

          Douglas Drossman, Dan L Dumitrascu (2006)
          The publication in the April, 2006 issue of Gastroenterology of Rome III has made available to the scientific world an enhanced and updated version of the Rome criteria and related information on the functional GI disorders. It is expected that the criteria will be adopted and used by physicians, pharmaceuticals and regulatory agencies worldwide, just as the previous Rome II became the standard for clinical practice and research. In this issue of J Gastrointestin Liver Dis, these Guidelines, the Rome III, are presented. Also included are some of the differences between Rome II and Rome III criteria as well as the rationale for publishing this new version.
          Article 0 comments Cited 149 times – based on 0 reviews     Review now
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            A placebo-controlled trial of prucalopride for severe chronic constipation.

            Lieve Vandeplassche, An Rykx, Rene Kerstens … (2008)
            In this 12-week trial, we aimed to determine the efficacy of prucalopride, a selective, high-affinity 5-hydroxytryptamine4 receptor agonist, in patients with severe chronic constipation. In our multicenter, randomized, placebo-controlled, parallel-group, phase 3 trial, patients with severe chronic constipation (< or =2 spontaneous, complete bowel movements per week) received placebo or 2 or 4 mg of prucalopride, once daily, for 12 weeks. The primary efficacy end point was the proportion of patients having three or more spontaneous, complete bowel movements per week, averaged over 12 weeks. Secondary efficacy end points were derived from daily diaries and validated questionnaires completed by patients. Adverse events, clinical laboratory values, and cardiovascular effects were monitored. Efficacy was analyzed in 620 patients. The proportion of patients with three or more spontaneous, complete bowel movements per week was 30.9% of those receiving 2 mg of prucalopride and 28.4% of those receiving 4 mg of prucalopride, as compared with 12.0% in the placebo group (P<0.001 for both comparisons). Over 12 weeks, 47.3% of patients receiving 2 mg of prucalopride and 46.6% of those receiving 4 mg of prucalopride had an increase in the number of spontaneous, complete bowel movements of one or more per week, on average, as compared with 25.8% in the placebo group (P<0.001 for both comparisons). All other secondary efficacy end points, including patients' satisfaction with their bowel function and treatment and their perception of the severity of their constipation symptoms, were significantly improved with the use of 2 or 4 mg of prucalopride as compared with placebo, at week 12. The most frequent treatment-related adverse events were headache and abdominal pain. There were no significant cardiovascular effects of treatment. Over 12 weeks, prucalopride significantly improved bowel function and reduced the severity of symptoms in patients with severe chronic constipation. Larger and longer trials are required to further assess the risks and benefits of the use of prucalopride for chronic constipation. (ClinicalTrials.gov number, NCT00483886 [ClinicalTrials.gov].). Copyright 2008 Massachusetts Medical Society.
            Article 0 comments Cited 145 times – based on 0 reviews     Review now
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              Methods for combining randomized clinical trials: strengths and limitations.

              D L DeMets (2015)
              Methods for combining data from several studies exist and appear to be quite useful. None satisfactorily addresses the question of what studies should be combined. This issue is the most serious methodological limitation. Even studies with statistically significant interaction might still be combined if the effect were in the same direction. Thus, substantial scientific input is required as to what criteria must be met by each potential study. Much can be learned from combining or pooling data but it must be done cautiously. Pooling exercises do not replace well designed prospective clinical trials. Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful.
              Article 0 comments Cited 89 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Neurogastroenterol Motil
                Journal ID (iso-abbrev): J Neurogastroenterol Motil
                Title: Journal of Neurogastroenterology and Motility
                Publisher: Korean Society of Neurogastroenterology and Motility
                ISSN (Print): 2093-0879
                ISSN (Electronic): 2093-0887
                Publication date (Print): July 2016
                Publication date (Electronic): 28 June 2016
                Volume: 22
                Issue: 3
                Pages: 412-422
                Affiliations
                [1 ]Department of General, Endoscopic and Laparoscopic Colorectal Surgery, Western Sussex Hospitals NHS Foundation Trust, Worthing Hospital, Worthing, UK
                [2 ]Department of Gastroenterology, Gastrointestinal Endoscopy and Hepatology, Western Sussex Hospitals NHS Foundation Trust, Worthing Hospital, Worthing, UK
                Author notes
                [* ]Correspondence: Muhammad S Sajid, FRCS, Associate Specialist in General and Colorectal Surgery, Worthing Hospital, Worthing West Sussex, BN11 2DH, UK, Tel: +44-01903-205-111, Fax: +44-01903-285-010, E-mail: surgeon1wrh@ 123456hotmail.com
                Article
                Publisher ID: jnm-22-412
                DOI: 10.5056/jnm16004
                PMC ID: 4930296
                PubMed ID: 27127190
                SO-VID: 076408f4-d9ba-4bf7-b029-8cab1bc72212
                Copyright © © 2016 The Korean Society of Neurogastroenterology and Motility
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 08 January 2016
                Date revision received : 14 February 2016
                Date accepted : 05 March 2016
                Categories
                Subject: Meta-Analysis

                ScienceOpen disciplines: Neurology
                Keywords: constipation,functional bowel disorders,laxatives,prucalopride,secondary constipation
                Data availability:
                ScienceOpen disciplines: Neurology
                Keywords: constipation, functional bowel disorders, laxatives, prucalopride, secondary constipation

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