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New phase III data for Resolor (prucalopride) published in The New England Journal of Medicine (NEJM) shows statistically and clinically significant improvement of bowel function and reduced severity of symptoms in patients with chronic constipation.
Prucalopride is the most advanced in a new generation of selective, high-affinity 5-HT4 receptor agonists, specifically designed to help patients for whom laxatives do not provide adequate relief.
In this randomised, placebo-controlled trial of 620 patients with severe chronic constipation, the proportion of patients achieving the primary study endpoint of average ≥3 spontaneous complete bowel movements per week (SCBM/week) was significantly higher in both Prucalopride groups (2mg and 4mg) compared with placebo over both four and 12 weeks of treatment.
Additionally, Prucalopride significantly improved the secondary efficacy endpoints, including satisfaction with bowel function and treatment, abdominal and stool symptoms, perception of constipation severity, and disease-related quality of life.
Jan Tack, Professor and Head of Clinic, Division of Gastroenterology, University Hospital Gasthuisberg, University of Leuven, Belgium, said: “These are valuable and relevant findings because the demanding endpoint in this study combines both a subjective measure of the completeness of evacuation with an objective measure of the number of bowel movements, reflecting relief of chronic constipation and normalisation of bowel function.
“The high selectivity of Prucalopride towards the 5-HT4 receptor offers the benefit that patients are unlikely to suffer from the side effects associated with the older generation, nonselective compounds. This meets the needs of doctors and patients by offering an effective treatment with an improved side-effect profile.”