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

BACKGROUND Racecadotril is an antidiarrhoeal drug with intestinal antisecretory mechanism of action. AIM To assess racecadotril efficacy as an adjunct to oral rehydration solution, against oral rehydration solution alone or with placebo in childhood acute gastroenteritis. METHODS Individual patient data meta-analysis following multilevel mixed models testing the significance of the treatment effect adjusted for baseline covariates. RESULTS 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. CONCLUSION 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.