| Popis: |
Constipation affects up to 50% of the elderly; this study evaluates the efficacy, safety, and tolerability of the selective 5-HT(4) agonist prucalopride in chronically constipated elderly patients.Three hundred chronic constipation patients agedor=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 withor=3 spontaneous complete bowel movements (SCBM) per week. Secondary endpoints included the percentage with an increase ofor=1 SCBM per week, BM frequency, constipation-related symptoms, quality of life (QoL), safety, and tolerability.More patients achievedor=3 SCBM per week with prucalopride than with placebo. This difference was largest and significant during the first week of 4 mg prucalopride (Por= 0.05). Significantly more patients in each prucalopride group achieved an increase ofor=1 SCBM per week from baseline vs placebo (e.g. 60% with 1 mg prucalopride vs 34% with placebo at week 4; Por= 0.05). More patients had improvement in PAC-QOL satisfaction score ofor=1 with 1 mg prucalopride than with placebo (Por= 0.05); the same was true for PAC-SYM stool symptoms (1 and 4 mg prucalopride; Por= 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.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. |
