This article, published in the August 2011 issue of the Drug and Therapeutics Bulletin (DTB), reviews the evidence for prucalopride (Resolor®) and considers its place in the treatment of chronic constipation.

Prucalopride is a serotonin (5HT4) receptor agonist with enterokinetic effects, licensed for the symptomatic treatment of chronic constipation in women, when laxatives fail to provide adequate relief.  This review covers the key clinical trials that have evaluated the safety and efficacy of prucalopride within its licensed indication, the limitations of these data, precautions and interactions, the background to its licensing, guidance from the NICE and SMC, and its cost.

The author of the review comments that the key efficacy trials were short (up to 12 weeks’ duration), did not compare prucalopride with existing treatments, and did not specify previous laxative use as an inclusion criterion.  Although the primary outcome (three or more spontaneous complete bowel movements per week) was statistically significant, no more than a third of patients randomised to prucalopride achieved this outcome.  The licensing of prucalopride was based on post-hoc subgroup analyses (due to the small number of men recruited) and side-effects are common; prucalopride is additionally expensive compared to existing laxative treatments available (28 days’ treatment of 1-2mg daily will cost the NHS £39-£60).

As a result of these issues, the DTB states that it cannot recommend prucalopride as a treatment for chronic constipation.