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

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). © 2010 Mayo Foundation for Medical Education and Research.