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  • Title: Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies.
    Author: Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L.
    Journal: Aliment Pharmacol Ther; 2010 Nov; 32(9):1113-23. PubMed ID: 21039673.
    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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