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Prucalopride: A Review of Its Use in the Management of Chronic Constipation

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Abstract

The highly selective serotonin 5-HT4 receptor agonist prucalopride (Resolor®, Resotran®, Resotrans®) is indicated for the treatment of chronic constipation. In four randomized, double-blind, multicentre, 12-week trials in patients (predominantly women) with chronic constipation, oral prucalopride 2 mg once daily improved bowel function to a significantly greater extent than placebo, with a significantly greater proportion of prucalopride than placebo recipients achieving an average of ≥3 spontaneous, complete bowel movements per week (primary endpoint). Significantly greater improvements in health-related quality of life, patient satisfaction with treatment and bowel habit, and a range of constipation-related symptoms were also seen with prucalopride than with placebo. Satisfaction with treatment and bowel habit was maintained with prucalopride in the longer term. Prucalopride was generally well tolerated in patients with chronic constipation, with the most commonly reported adverse events (headache, nausea, abdominal pain, diarrhoea) primarily occurring on the first day of treatment. During the clinical trials, no cardiovascular safety issues have arisen in patients with chronic constipation receiving prucalopride. In conclusion, prucalopride is an important option for use in patients with chronic constipation who have not experienced adequate relief with laxatives.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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    Gillian M. Keating

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Correspondence to Gillian M. Keating.

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The manuscript was reviewed by: S.A. Müller-Lissner, Department of Internal Medicine, Park-Klinik Weissensee, Berlin, Germany; E.M.M. Quigley, Alimentary Pharmabiotic Centre, University College Cork, Cork, Ireland; C. Scarpignato, Clinical Pharmacology & Digestive Pathophysiology Unit, Department of Clinical & Experimental Medicine, University of Parma, Parma, Italy; M. Simrén, Department of Internal Medicine & Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; V. Stanghellini, Department of Digestive Diseases and Internal Medicine, University of Bologna, St Orsola-Malpighi Hospital, Bologna, Italy.

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Keating, G.M. Prucalopride: A Review of Its Use in the Management of Chronic Constipation. Drugs 73, 1935–1950 (2013). https://doi.org/10.1007/s40265-013-0140-1

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