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Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis.

ABSTRACT: Prucalopride is a selective, high-affinity, 5-hydroxytryptamine (serotonin) type 4 (5-HT4) receptor agonist with gastrointestinal prokinetic activities. This integrated analysis of data from three double-blind phase III trials (ClinicalTrials.gov: NCT00488137, NCT00483886, NCT00485940) compared the efficacy and safety of prucalopride 2?mg once daily in women with chronic constipation [?2 spontaneous complete bowel movements (SCBM) per week] in whom laxatives had failed to provide adequate relief with that in the all-patient (AP) population of men and women with chronic constipation who had or had not obtained relief from laxatives.Patients received prucalopride 2?mg or placebo once-daily for 12 weeks. Efficacy endpoints included an average of ?3 SCBM/week and average increases of ?1 SCBM/week and ?1 SBM/week over this period. A response on any of these three endpoints was considered to be clinically relevant, and an overall response rate was derived for patients satisfying any of these endpoints.Of the AP population (n?=?1318), 936 were women in whom laxatives had failed to provide adequate relief (WLF). More patients on prucalopride 2?mg than placebo had an average of ?3 SCBM/week (AP 24.4 vs 11.0%; WLF 24.7 vs 9.2%), an average increase of ?1 SCBM/week (AP 43.5 vs 24.8%; WLF 44.2 vs 22.6%), and an average increase of ?1 SBM/week (AP 66.7 vs 38.4%; WLF 68.3 vs 37.0%) (all p?10%) adverse events were abdominal pain, nausea, diarrhoea, and headache.Prucalopride 2?mg once daily is effective in WLF. The efficacy and safety profile observed in WLF was similar to that in the total evaluated population of patients with chronic constipation who had or had not obtained adequate relief from laxatives.

SUBMITTER: Tack J

PROVIDER: S-EPMC4040783 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis.

Tack Jan J Quigley Eamonn E Camilleri Michael M Vandeplassche Lieve L Kerstens René R

United European gastroenterology journal 20130201 1

<h4>Background</h4>Prucalopride is a selective, high-affinity, 5-hydroxytryptamine (serotonin) type 4 (5-HT4) receptor agonist with gastrointestinal prokinetic activities. This integrated analysis of data from three double-blind phase III trials (ClinicalTrials.gov: NCT00488137, NCT00483886, NCT00485940) compared the efficacy and safety of prucalopride 2 mg once daily in women with chronic constipation [≤2 spontaneous complete bowel movements (SCBM) per week] in whom laxatives had failed to prov ...[more]

PMID: 24917940

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Project description:BackgroundThis article describes the second update of a Cochrane review on the effectiveness of laxatives for the management of constipation in people receiving palliative care. Previous versions were published in 2006 and 2010 where we also evaluated trials of methylnaltrexone; these trials have been removed as they are included in another review in press. In these earlier versions, we drew no conclusions on individual effectiveness of different laxatives because of the limited number of evaluations. This is despite constipation being common in palliative care, generating considerable suffering due to the unpleasant physical symptoms and the availability of a wide range of laxatives with known differences in effect in other populations.ObjectivesTo determine the effectiveness and differential efficacy of laxatives used to manage constipation in people receiving palliative care.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), MEDLINE, EMBASE, CINAHL and Web of Science (SCI & CPCI-S) for trials to September 2014.Selection criteriaRandomised controlled trials (RCTs) evaluating laxatives for constipation in people receiving palliative care.Data collection and analysisTwo authors assessed trial quality and extracted data. The appropriateness of combining data from the studies depended upon clinical and outcome measure homogeneity.Main resultsWe identified five studies involving the laxatives lactulose, senna, co-danthramer, misrakasneham, docusate and magnesium hydroxide with liquid paraffin. Overall, the study findings were at an unclear risk of bias. As all five studies compared different laxatives or combinations of laxatives, it was not possible to perform a meta-analysis. There was no evidence on whether individual laxatives were more effective than others or caused fewer adverse effects.Authors' conclusionsThis second update found that laxatives were of similar effectiveness but the evidence remains limited due to insufficient data from a few small RCTs. None of the studies evaluated polyethylene glycol or any intervention given rectally. There is a need for more trials to evaluate the effectiveness of laxatives in palliative care populations. Extrapolating findings on the effectiveness of laxatives evaluated in other populations should proceed with caution. This is because of the differences inherent in people receiving palliative care that may impact, in a likely negative way, on the effect of a laxative.

Dataset Information

Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis.

Publications

Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis.

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