TY - JOUR
T1 - Clinical trial
T2 - The efficacy of open-label prucalopride treatment in patients with chronic constipation - Follow-up of patients from the pivotal studies
AU - Camilleri, M.
AU - Van Outryve, M. J.
AU - Beyens, G.
AU - Kerstens, R.
AU - Robinson, P.
AU - Vandeplassche, L.
PY - 2010/11
Y1 - 2010/11
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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U2 - 10.1111/j.1365-2036.2010.04455.x
DO - 10.1111/j.1365-2036.2010.04455.x
M3 - Article
C2 - 21039673
AN - SCOPUS:78649484435
SN - 0269-2813
VL - 32
SP - 1113
EP - 1123
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 9
ER -