A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation
Article first published online: 7 JUN 2010
© 2010 Blackwell Publishing Ltd
Neurogastroenterology & Motility
Volume 22, Issue 9, pages 991–e255, September 2010
How to Cite
Müller-lissner, S., Rykx, A., Kerstens, R. and Vandeplassche, L. (2010), A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterology & Motility, 22: 991–e255. doi: 10.1111/j.1365-2982.2010.01533.x
- Issue published online: 4 AUG 2010
- Article first published online: 7 JUN 2010
- Received: 3 December 2009 Accepted for publication: 7 May 2010
- 5-HT4 receptors;
- colon motility;
Background Constipation affects up to 50% of the elderly; this study evaluates the efficacy, safety, and tolerability of the selective 5-HT4 agonist prucalopride in chronically constipated elderly patients.
Methods Three hundred chronic constipation patients aged ≥65 years were randomized to prucalopride (1, 2, or 4 mg once daily) or placebo for 4 weeks. The primary endpoint was the percentage of patients with ≥3 spontaneous complete bowel movements (SCBM) per week. Secondary endpoints included the percentage with an increase of ≥1 SCBM per week, BM frequency, constipation-related symptoms, quality of life (QoL), safety, and tolerability.
Key Results More patients achieved ≥3 SCBM per week with prucalopride than with placebo. This difference was largest and significant during the first week of 4 mg prucalopride (P ≤ 0.05). Significantly more patients in each prucalopride group achieved an increase of ≥1 SCBM per week from baseline vs placebo (e.g. 60% with 1 mg prucalopride vs 34% with placebo at week 4; P ≤ 0.05). More patients had improvement in PAC-QOL satisfaction score of ≥1 with 1 mg prucalopride than with placebo (P ≤ 0.05); the same was true for PAC-SYM stool symptoms (1 and 4 mg prucalopride; P ≤ 0.05). Treatment-emergent adverse events were similar between groups: the most frequently reported with prucalopride were headache and gastrointestinal events. There were no clinically significant differences between prucalopride and placebo for vital signs, laboratory assessments, or ECG variables.
Conclusions & Inferences Prucalopride, in the dose-range tested (1–4 mg once daily), has beneficial effects on bowel movements, symptoms, and QoL, and is safe and well-tolerated in elderly patients with chronic constipation.