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Title
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Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation: follow-up of patients from the pivotal studies
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Author
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Abstract
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| Background Prucalopride is approved in Europe for symptomatic treatment of chronic constipation in women with inadequate relief from laxatives. Aim To evaluate efficacy of prucalopride during long-term treatment of patients with chronic constipation. Methods Patients from three pivotal double-blind, placebo-controlled, 12-week studies with prucalopride could continue treatment in open-label studies up to 24 months. Efficacy was evaluated every 3 months using the Patient Assessment of Constipation-Quality of Life (PAC-QOL) satisfaction scale. Laxative use and reasons for study discontinuation were recorded. Results Eighty-six percent of patients who completed the pivotal studies continued prucalopride treatment in the open-label studies (n = 1455, 90% female). Improvement in average PAC-QOL satisfaction score observed after 12-week, double-blind prucalopride was maintained during open-label treatment for up to 18 months; in each 3 month period, 4050% of patients did not use any laxatives. Most frequent adverse events (AEs) resulting in discontinuation were gastrointestinal events (3.3%) and headache (1.0%). Only 10% of patients who had normalized bowel function on prucalopride at the end of pivotal trials discontinued due to insufficient response during open-label treatment. Conclusion Satisfaction with bowel function is maintained for up to 18 months of treatment with prucalopride. Gastrointestinal events and headache cause discontinuation of prucalopride treatment in ∼5% of patients (ClinicalTrials.gov identifiers: NCT01070615 and NCT00987844). |
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Language
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English
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Source (journal)
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Alimentary pharmacology and therapeutics. - Oxford
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Publication
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Oxford
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2010
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ISSN
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0269-2813
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DOI
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10.1111/J.1365-2036.2010.04455.X
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Volume/pages
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32
:9
(2010)
, p. 1113-1123
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ISI
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000282570800007
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Full text (Publisher's DOI)
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