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Published online: 1 December 2015
© Springer International Publishing Switzerland 2015
Abstract Prucalopride (Resolor®), a highly selective serotonin 5-HT^sub 4^ 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.
1 Introduction
Chronic idiopathic constipation (CIC), also known as functional constipation, presents as persistently difficult, infrequent or seemingly incomplete defecation that is not consistent with irritable bowel syndrome-constipation (IBS-C) criteria [1]. Constipation is more common in women [1, 2], the elderly, and those of lower socioeconomic status [2]. CIC is associated with impaired healthrelated quality of life (HR-QOL), especially in elderly patients [2]. CIC is generally divided into two categories: slow-transit constipation (colonic inertia; manifests as infrequent stools) and 'outlet-type' constipation (defecatory dysfunction or anismus; manifests as difficulty associated with the act of defecation, such as straining or incomplete evacuation) [3].
Traditionally, treatment options for CIC include lifestyle and dietary changes, as well as the use of osmotic [e.g. polyethylene glycol (PEG)] or stimulant (e.g. bisacodyl or sodium picosulfate) laxatives [1, 2]. More recently, prucalopride [Resolor^, a selective, high-affinity serotonin (5-HT4) receptor agonist with gastrointestinal prokinetic properties [2]] and prosecretory agents (e.g. linaclotide, lubiprostone) have been investigated; the availability of these newer drugs differs between markets.
Oral prucalopride 1-2 mg/day...