• M Camilleri, M J Van Outryve, G Beyens, R Kerstens, P Robinson, and L Vandeplassche.
• Mayo Clinic, Rochester, MN 55905, USA. camilleri.michael@mayo.edu
• Aliment. Pharmacol. Ther. 2010 Nov 1;32(9):1113-23.

BackgroundPrucalopride is approved in Europe for symptomatic treatment of chronic constipation in women with inadequate relief from laxatives.AimTo evaluate efficacy of prucalopride during long-term treatment of patients with chronic constipation.MethodsPatients 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.ResultsEighty-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.ConclusionSatisfaction 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).© 2010 Mayo Foundation for Medical Education and Research.

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