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    Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation--a 12-week, randomized, double-blind, placebo-controlled study.

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    Authors
    Quigley, E M M
    Vandeplassche, L
    Kerstens, R
    Ausma, J
    Affiliation
    Alimentary Pharmabiotic Centre, University College Cork, Cork, Ireland. e.quigley@ucc.ie
    Issue Date
    2009-02-01
    MeSH
    Administration, Oral
    Adolescent
    Adult
    Aged
    Aged, 80 and over
    Benzofurans
    Chronic Disease
    Constipation
    Defecation
    Double-Blind Method
    Female
    Gastrointestinal Transit
    Humans
    Male
    Middle Aged
    Patient Satisfaction
    Placebos
    Quality of Life
    Questionnaires
    Serotonin Receptor Agonists
    Treatment Outcome
    Young Adult
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    Citation
    Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation--a 12-week, randomized, double-blind, placebo-controlled study. 2009, 29 (3):315-28 Aliment. Pharmacol. Ther.
    Journal
    Alimentary pharmacology & therapeutics
    URI
    http://hdl.handle.net/10147/201249
    DOI
    10.1111/j.1365-2036.2008.03884.x
    PubMed ID
    19035970
    Abstract
    Chronic constipation may result in disabling symptoms, is often unsatisfactorily treated by laxatives and negatively impacts quality of life (QoL).
    A randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy and safety of a selective, high-affinity 5-HT(4) receptor agonist, prucalopride, in patients with chronic constipation [
    Placebo, 2 or 4 mg prucalopride was administered orally once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients with >or=3 SCBMs/week, averaged over 12 weeks. Other assessments included BM frequency, constipation-related QoL and symptoms and tolerability.
    Among 641 patients, significantly more patients taking prucalopride 2 or 4 mg (24%) than placebo (12%), achieved the primary efficacy endpoint (>or=3 SCBMs/week) or an increase of >or=1 SCBMs/week; 43% and 47% vs. 28% respectively. Prucalopride-treated patients also achieved significantly greater satisfaction with treatment and bowel function, and improved perception of constipation severity and constipation-related QoL, compared with placebo. Most frequent treatment-related adverse events were headache, abdominal pain, nausea and diarrhoea (mainly during day 1). There were no differences in comparison to placebo in the incidence of serious adverse effects or cardiovascular events.
    Over 12 weeks, prucalopride was effective and well tolerated in chronic constipation.
    Item Type
    Article
    Language
    en
    ISSN
    1365-2036
    ae974a485f413a2113503eed53cd6c53
    10.1111/j.1365-2036.2008.03884.x
    Scopus Count
    Collections
    Cork University Hospital

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