These authors contributed equally.
Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation – follow-up of patients from the pivotal studies
Article first published online: 16 SEP 2010
© 2010 Mayo Foundation for Medical Education and Research
Alimentary Pharmacology & Therapeutics
Volume 32, Issue 9, pages 1113–1123, November 2010
How to Cite
Camilleri, M., Van Outryve, M. J., Beyens, G., Kerstens, R., Robinson, P. and Vandeplassche, L. (2010), Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation – follow-up of patients from the pivotal studies. Alimentary Pharmacology & Therapeutics, 32: 1113–1123. doi: 10.1111/j.1365-2036.2010.04455.x
- Issue published online: 6 OCT 2010
- Article first published online: 16 SEP 2010
- Publication data Submitted 22 July 2010 First decision 10 August 2010 Resubmitted 23 August 2010 Accepted 23 August 2010 EV Pub Online 16 September 2010
Aliment Pharmacol Ther 2010; 32: 1113–1123
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).