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

Abstract

BACKGROUND:

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.

METHODS:

Three hundred chronic constipation patients aged >or=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 >or=3 spontaneous complete bowel movements (SCBM) per week. Secondary endpoints included the percentage with an increase of >or=1 SCBM per week, BM frequency, constipation-related symptoms, quality of life (QoL), safety, and tolerability.

KEY RESULTS:

More patients achieved >or=3 SCBM per week with prucalopride than with placebo. This difference was largest and significant during the first week of 4 mg prucalopride (P <or= 0.05). Significantly more patients in each prucalopride group achieved an increase of >or=1 SCBM per week from baseline vs placebo (e.g. 60% with 1 mg prucalopride vs 34% with placebo at week 4; P <or= 0.05). More patients had improvement in PAC-QOL satisfaction score of >or=1 with 1 mg prucalopride than with placebo (P <or= 0.05); the same was true for PAC-SYM stool symptoms (1 and 4 mg prucalopride; P <or= 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.

• Authors: S Müller-Lissner, A Rykx, R Kerstens, L Vandeplassche
• Journal: Neurogastroenterology and motility (Neurogastroenterol Motil) Vol. 22 Issue 9 Pg. 991-8, e255 (Sep 2010) ISSN: 1365-2982 [Electronic] England
• PMID: 20529205 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Benzofurans
• prucalopride

Topics

• Aged
• Aged, 80 and over
• Benzofurans (therapeutic use)
• Chi-Square Distribution
• Chronic Disease (drug therapy)
• Constipation (drug therapy)
• Defecation (drug effects)
• Double-Blind Method
• Female
• Humans
• Intention to Treat Analysis
• Male
• Quality of Life
• Treatment Outcome