Objective: To determine the efficacy, impact on quality of life (QOL) and safety of prucalopride, a selective, high-affinity 5-HT4 receptor agonist, in patients with chronic constipation.
Methods: In this multicentre, randomised, placebo controlled, parallel-group, phase III study, patients with chronic constipation (two or fewer spontaneous complete bowel movements (SCBM)/week) received 2 mg or 4 mg prucalopride or placebo, once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients reaching three or more SCBM/week. The key secondary efficacy endpoint was the proportion of patients having an increase of one or more SCBM/week. The primary QOL endpoint was the patient assessment of constipation QOL satisfaction subscale score. Safety parameters included adverse events, laboratory values and cardiovascular events.
Results: Efficacy was evaluated over 713 patients. Averaged over 12 weeks, higher proportions of patients on prucalopride 2 mg (19.5%; p<0.01), 4 mg (23.6%; p<0.001) had three or more SCBM/week (or normalisation of bowel function) compared with placebo (9.6%). Similar results were seen in the subgroup (83%) of patients dissatisfied with previous laxative treatment. Both doses of prucalopride also significantly improved secondary efficacy and QOL endpoints, including the proportion of patients with an increase of one or more SCBM/week, evacuation completeness, perceived disease severity and treatment effectiveness and QOL. Prucalopride 4 mg significantly reduced the need for straining versus placebo (p<0.05). The most frequent treatment-related adverse events were headache and diarrhoea. Both doses of prucalopride were safe and well tolerated.
Conclusion: Prucalopride significantly and consistently improved bowel function, associated symptoms and satisfaction in chronically constipated patients.
Trial registration number: NCT00488137.
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Funding: The study design and data collection were funded by Janssen Research Foundation, Beerse, Belgium. The analysis and interpretation of the data were funded by Movetis NV, Turnhout, Belgium.
Competing interests: JT has been a scientific advisor for Johnson & Johnson and Movetis. MvO has received consultancy fees from Movetis. GB, RK and LV are employees of Movetis NV, Turnhout, Belgium. Writing assistance was provided by Archimed Medical Communication Ag, Zofingen, Switzerland.
Ethics approval: The clinical trial protocol was reviewed and approved by the appropriate independent ethics committees.
Patient consent: Obtained.
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