Efficacy and tolerability of racecadotril in acute diarrhea in children

Background&Aims: Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. Antisecret ory drugs available could not be used because of their side effects, except for racecadotril, which is efficient in acute diarrhea in adults. Methods: The efficacy and tolerability of racecadotril (1.5 mg/kg administered oral ly 3 times daily) as adjuvant therapy to oral rehydration were compared wit h those of placebo in 172 infants aged 3 months to 4 years (mean age, 12.8 months) who had acute diarrhea, The treatment groups were comparable in ter ms of age, duration of diarrhea, number of stools, and causative microorgan ism at Inclusion. Results: During the first 48 hours of treatment, patients receiving racecadotril had a significantly lower stool output (grams per h our) than those receiving placebo. The 95% confidence interval was 43%-88% for the full data set (n = 166; P = 0.009) and 33%-75% for the per-protocol population (n = 116; P = 0.001), There was no difference between treatment s depending on rotavirus status. Significant differences between treatment groups were also found after 24 hours of treatment: full data set (n = 167; P = 0.026) and per-protocol population (n = 121; P = 0.015), Tolerability was good in both groups of patients. Conclusions: This study demonstrates t he efficacy (up to 50% reduction in stool output) and tolerability of racec adotril as adjuvant therapy to oral rehydration solution in the treatment o f severe diarrhea in infants and children.