Clinical trial: The efficacy of open-label prucalopride treatment in patients with chronic constipation - Follow-up of patients from the pivotal studies

Michael Camilleri, M. J. Van Outryve, G. Beyens, R. Kerstens, P. Robinson, L. Vandeplassche

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Abstract

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, 40-50% 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).

Original languageEnglish (US)
Pages (from-to)1113-1123
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume32
Issue number9
DOIs
StatePublished - Nov 2010

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prucalopride
Constipation
Clinical Trials
Laxatives
Therapeutics
Headache
Quality of Life

ASJC Scopus subject areas

  • Pharmacology (medical)

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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. / Camilleri, Michael; Van Outryve, M. J.; Beyens, G.; Kerstens, R.; Robinson, P.; Vandeplassche, L.

In: Alimentary Pharmacology and Therapeutics, Vol. 32, No. 9, 11.2010, p. 1113-1123.

Research output: Contribution to journalArticle

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abstract = "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, 40-50{\%} 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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N2 - 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, 40-50% 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).

AB - 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, 40-50% 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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