Efficacy and tolerability of racecadotril in acute diarrhea in children

doi:10.1053/gast.2001.22544

Gastroenterology

Volume 120, Issue 4, March 2001, Pages 799-805

https://doi.org/10.1053/gast.2001.22544 Get rights and content

Abstract

Background & Aims: Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. Antisecretory 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 orally 3 times daily) as adjuvant therapy to oral rehydration were compared with 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 terms of age, duration of diarrhea, number of stools, and causative microorganism at inclusion. Results: During the first 48 hours of treatment, patients receiving racecadotril had a significantly lower stool output (grams per hour) 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 treatments 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 the efficacy (up to 50% reduction in stool output) and tolerability of racecadotril as adjuvant therapy to oral rehydration solution in the treatment of severe diarrhea in infants and children.

GASTROENTEROLOGY 2001;120:799-805

Section snippets

Study population

A randomized, double-blind, placebo-controlled study was carried out in 13 separate centers. A total of 172 children hospitalized for severe acute diarrhea and aged 3 months to 4 years (mean, 12.8 months) of both sexes (71 girls and 101 boys) entered the study. Patients of both genders were included to reflect the actual use of racecadotril in routine clinical practice. The centers included 167 patients (97%). For each of these centers, the number of patients was at least 5 (range, 5–29

Study population

Of the 172 patients who entered the study (89 in racecadotril group and 83 in placebo group), 4 were excluded because their stool weights were not recorded (3 in racecadotril group and 1 placebo group). Stool weights could not be estimated in 2 other patients receiving racecadotril (1 from 12 to 24 hours and 1 from 24 to 36 hours) because no stools were passed during any other periods. These data were therefore recorded as missing.

The full data set consisted of 86 patients who received

Discussion

The results of this study establish the efficacy of racecadotril as an adjunct to oral rehydration therapy and early continued feeding in infants and children with acute diarrhea. Patients who received racecadotril had a statistically significant reduction in stool output compared with those who received placebo; the mean reduction in stool output with racecadotril was 50% in the per-protocol population and 40% in the full data set. The rapidity of effect on stool output was shown by the fact

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Alimentary TractEfficacy and tolerability of racecadotril in acute diarrhea in children☆

Abstract

Section snippets

Study population

Study population

Discussion

Neuropeptides

Eur J Pharmacol

Pediatr Pharmacol Ther

Lancet

A manual for the treatment of acute diarrhea for use by physicians and other senior health workers

The rational use of drugs in the management of acute diarrhoea in children

Diarrheal mortality in two Bangladeshi villages with community based oral rehydration therapy

Lancet

Twin brush border metallo-endopeptidases

Racecadotril demonstrates intestinal antisecretory activity in vivo

Aliment Pharmacol Ther

Acetorphan prevents cholera toxin-induced water and electrolyte secretion in the human jejunum

Gastroenterology

Effects of acetorphan, an enkephalinase inhibitor, on experimental and acute diarrhoea

Gut

Effects of acetorphan, an antidiarrhoeal enkephalinase inhibitor, on oro-caecal and colonic transit times in healthy volunteers

Aliment Pharmacol Ther

Racecadotril versus placebo in the treatment of acute diarrhoea in adults

Aliment Pharmacol Ther

Logarithmic transformations in ANOVA

Biometrics

A controlled trial of bismuth subsalicylate in infants with acute watery diarrheal disease

N Engl J Med

Alimentary Tract
Efficacy and tolerability of racecadotril in acute diarrhea in children☆