Efficacy and Safety of Prucalopride in Chronic Constipation.


eMediNexus    06 January 2018

A study published in Digestive Diseases and Sciences aimed to evaluate the relative efficacy of prucalopride in relieving common symptoms of chronic constipation (CC), by gender. This study utilized data from six large, randomized, controlled clinical trials to evaluate the global efficacy and safety of prucalopride, 2 mg daily, in men and women with CC. The primary efficacy endpoint was the percentage of patients with a mean of ≥3 spontaneous complete bowel movements (SCBMs) per week, over 12 weeks of treatment.  Overall, 2484 patients were included in the integrated efficacy analysis, which comprised 597 men, 1887 women, and 1237 receiving prucalopride, while 1247 receiving placebo; whereas 2552 patients were included in the integrated safety analysis. The results showed that a significantly higher number of patients achieved a mean of ≥3 SCBMs/week, over the 12 weeks of treatment in the prucalopride group than in the placebo group. Additionally, prucalopride had a favorable safety and tolerability profile. Furthermore, efficacy and safety outcomes were not significantly different between men and women. Hence, this integrated analysis demonstrated the efficacy and safety of prucalopride in the treatment of CC in men and women.1


  1. Camilleri M, Piessevaux H, Yiannakou Y et al. Efficacy and Safety of Prucalopride in Chronic Constipation: An Integrated Analysis of Six Randomized, Controlled Clinical Trials. Digestive Diseases and Sciences. 2016;61(8):2357-2372. doi:10.1007/s10620-016-4147-9.

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