Prucalopride: A Review in Chronic Idiopathic Constipation

Drugs. 2016 Jan;76(1):99-110. doi: 10.1007/s40265-015-0518-3.

Abstract

Prucalopride (Resolor®), a highly selective serotonin 5-HT4 receptor agonist, is indicated in the European Economic Area for the treatment of adults with chronic idiopathic constipation (CIC) in whom laxatives have failed to provide adequate relief. This article reviews the pharmacological properties of prucalopride and its clinical efficacy and tolerability in patients with CIC. In five well-designed, 12-week trials in patients with CIC, oral prucalopride 2 mg/day was significantly more effective than placebo at improving bowel function, including the number of bowel movements and a range of other constipation symptoms, as well as health-related quality of life and patient satisfaction; however, no significant differences in bowel function measures were observed between prucalopride and placebo in a 24-week trial. Oral PEG-3350 + electrolytes reconstituted powder was found to be noninferior but not superior to prucalopride according to primary endpoint data from a 4-week, controlled-environment trial. Prucalopride was generally well tolerated in clinical trials; the most common adverse events were headache, diarrhoea, nausea and abdominal pain. No cardiovascular safety issues have arisen with prucalopride treatment. Although further long-term and comparative data would be beneficial, prucalopride provides an additional treatment option for patients with CIC.

Publication types

  • Review

MeSH terms

  • Benzofurans / adverse effects
  • Benzofurans / pharmacokinetics
  • Benzofurans / pharmacology
  • Benzofurans / therapeutic use*
  • Chronic Disease
  • Constipation / drug therapy*
  • Humans
  • Laxatives / adverse effects
  • Laxatives / pharmacokinetics
  • Laxatives / pharmacology
  • Laxatives / therapeutic use
  • Serotonin 5-HT4 Receptor Agonists / adverse effects
  • Serotonin 5-HT4 Receptor Agonists / pharmacokinetics
  • Serotonin 5-HT4 Receptor Agonists / pharmacology
  • Serotonin 5-HT4 Receptor Agonists / therapeutic use

Substances

  • Benzofurans
  • Laxatives
  • Serotonin 5-HT4 Receptor Agonists
  • prucalopride