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-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.


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
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.
Park-Klinik Weissensee, Berlin, Germany. mueli@park-klinik.com
S
S
Müller-Lissner
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A
Rykx
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R
Kerstens
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L
Vandeplassche
D000368:Aged; D000369:Aged, 80 and over; D001572:Benzofurans / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002908:Chronic Disease / Q000188:drug therapy; D003248:Constipation / Q000188:drug therapy*; D003672:Defecation / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D011788:Quality of Life; D016896:Treatment Outcome
D001572:Benzofurans; C406662:prucalopride