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Prucalopride: A Review in Chronic Idiopathic Constipation

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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.

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Acknowledgments

During the peer review process, the manufacturer of prucalopride was also offered an opportunity to review this article. Any changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Karly P. Garnock-Jones

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  1. Karly P. Garnock-Jones
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Correspondence to Karly P. Garnock-Jones.

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The preparation of this review was not supported by any external funding.

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Karly Garnock-Jones is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: M. Benninga, Department of Pediatric Gastroenterology & Nutrition, Emma Children’s Hospital, Amsterdam, The Netherlands; M. Larrosa, Universidad Europea de Madrid, Madrid, Spain; A. Lopez, Department of Hepato-Gastro-Enterology, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France; G. Maconi, Department of Biomedical and Clinical Sciences, “Luigi Sacco” University Hospital, Milan, Italy; E. Quigley, Department of Gastroenterology and Hepatology, The Methodist Hospital and Weill Cornell Medical College, Houston, TX, USA; C. Scarpignato, Department of Medicine, University of Parma and Maggiore University Hospital, Parma, Italy.

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Garnock-Jones, K.P. Prucalopride: A Review in Chronic Idiopathic Constipation. Drugs 76, 99–110 (2016). https://doi.org/10.1007/s40265-015-0518-3

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