A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation

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.