Evidence map›Paper›PMID 27056037›Full record

ArticleDigestive diseases and sciences2016

Efficacy and Safety of Prucalopride in Chronic Constipation: An Integrated Analysis of Six Randomized, Controlled Clinical Trials.

Michael Camilleri, Hubert Piessevaux, Yan Yiannakou, Jan Tack, René Kerstens, Eamonn M M Quigley, MeiYun Ke, Susana Da Silva, Amy Levine

Open access · hybridAbstract read
In one paragraph

Article in Digestive diseases and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 85 citations in OpenAlex.

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  9. Comparison of enteral prucaloprideFrontiers in pharmacology · 2024
    Article
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  15. Medical Management of Constipation in Elderly Patients: Systematic Review.Journal of neurogastroenterology and motility · 2021
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 5 countries.

Michael CamilleriC.E.N.T.E.R., Mayo Clinic College of Medicine, Charlton 8-110, 200 First St. S.W., Rochester, MN, 55905, USA. camilleri.michael@mayo.edu.
Hubert PiessevauxCliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
Yan YiannakouCounty Durham and Darlington NHS Foundation Trust, Durham, UK.
Jan TackTranslational Research Center for Gastrointestinal Disorders TARGID, University of Leuven, Leuven, Belgium.
René KerstensOrion Statistical Consulting BV, Hilvarenbeek, The Netherlands.
Eamonn M M QuigleyDivision of Gastroenterology and Hepatology, Lynda K and David M Underwood Center for Digestive Disorders, Houston Methodist Hospital and Weill Cornell Medical College, Houston, TX, USA.
MeiYun KePeking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China.
Susana Da SilvaShire, Brussels, Belgium.
Amy LevineShire, Wayne, PA, USA.
Centraal Bureau voor de Statistiek · NLChinese Academy of Medical Sciences & Peking Union Medical College · CNCliniques Universitaires Saint-Luc · BECornell University · USCounty Durham and Darlington NHS Foundation Trust · GBKU Leuven · BEMayo Clinic · USTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrucalopride, a selective, high-affinity 5-hydroxytryptamine 4 receptor agonist, stimulates gastrointestinal and colonic motility and alleviates common symptoms of chronic constipation (CC) in adults. The relative efficacy by gender has not been evaluated.

aimTo evaluate the global efficacy and safety of prucalopride 2 mg daily in men and women with CC using data from six large, randomized, controlled clinical trials.

methodsData were combined from six phase 3 and 4, double-blind, randomized, placebo-controlled, parallel-group trials. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week over 12 weeks of treatment. Safety was assessed throughout all the trials.

resultsOverall, 2484 patients (597 men; 1887 women; prucalopride, 1237; placebo, 1247) were included in the integrated efficacy analysis and 2552 patients were included in the integrated safety analysis. Significantly more patients achieved a mean of ≥3 SCBMs/week over the 12 weeks of treatment in the prucalopride group (27.8 %) than in the placebo group [13.2 %, OR 2.68 (95 % CI 2.16, 3.33), p < 0.001]. Prucalopride had a favorable safety and tolerability profile. Efficacy and safety outcomes were not significantly different between men and women.

conclusionThe integrated analysis demonstrates the efficacy and safety of prucalopride in the treatment of CC in men and women.

Indexed as

AdolescentAdultAgedAged, 80 and overBenzofuransChronic DiseaseClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicConstipationDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicSerotonin 5-HT4 Receptor AgonistsBenzofuransprucaloprideSerotonin 5-HT4 Receptor AgonistsConstipationEfficacyPrucaloprideSafety

Identifiers

PMID27056037
PMCPMC4943977
OpenAlexW2321527489

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.