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

Authors


Address for CorrespondenceStefan Müller-Lissner, Professor of Medicine, Park-Klinik Weissensee, Schoenstrasse 80, 13086 Berlin, Germany.
Tel: +49 30 9628 3600; fax: +49 30 9628 3605;
e-mail: mueli@park-klinik.com; stefan@mueller-lissner.de

Abstract

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.

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