Racecadotril for childhood gastroenteritis: an individual patient data meta-analysis.

Philippe Lehert, Gérard Chéron, Guillermo Alvarez Calatayud, Jean-Pierre Cézard, Pedro Gutierrez Castrellón, José-Manuel Meléndez Garcia, Mar Santos, M R Savitha

Index: Dig. Liver Dis. 43(9) , 707-13, (2011)

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Abstract

Racecadotril is an antidiarrhoeal drug with intestinal antisecretory mechanism of action.To assess racecadotril efficacy as an adjunct to oral rehydration solution, against oral rehydration solution alone or with placebo in childhood acute gastroenteritis.Individual patient data meta-analysis following multilevel mixed models testing the significance of the treatment effect adjusted for baseline covariates.Nine randomised clinical trials (n=1384) were identified with raw data. Baseline dehydration level and Rotavirus were found as two essential predictors influencing the outcomes. The proportion of recovered patients was higher in racecadotril groups compared with placebo, Hazard Ratio HR=2.04, 95% CI (1.85; 2.32), p<0.001. For inpatient studies, the ratio of mean stool output racecadotril/placebo was 0.59 (0.51; 0.74), p<0.001. For outpatient studies, the ratio of the mean number of diarrhoeic stools racecadotril/placebo was 0.63 (0.51; 0.74), p<0.001.Dehydration level and Rotavirus at baseline are essential adjustments to compare treatments. As an adjunct to oral rehydration solution, racecadotril has a clinically relevant effect in reducing diarrhoea (duration, stool output and stool number), irrespective of baseline conditions (dehydration, Rotavirus or age), treatment conditions (inpatient or outpatient studies) or cultural environment.Copyright © 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.