Comparison of racecadotril and loperamide in children with acute diarrhoea.

Abstract

METHODS:

A multicentre, parallel-group, double-blind, double-placebo study was carried out to compare the efficacy, tolerability, and safety of racecadotril and loperamide in children aged 2 to 10 years who were suffering from acute diarrhoea. Patients received racecadotril (1.5 mg/kg) or loperamide (0.03 mg/kg) three times daily plus matching placebo until recovery. Fifty-two children received racecadotril and 50 loperamide.

RESULTS:

Patients on racecadotril passed a mean (+/- S.E.M.) of 2.7 +/- 0.4 stools before recovery compared with 2.1 +/- 0.4 stools for loperamide. The duration of diarrhoea was similar with both treatments. The incidence of adverse events was lower with racecadotril than with loperamide (11.5% vs. 22%), and significantly more patients on loperamide suffered from constipation (58% vs. 36.5%; P = 0.03). Moreover, significantly more children receiving loperamide required concomitant medication during the study (38% v 19.2%; P = 0.047). Measurement of abdominal circumference at the final consultation, 6 days after entry to the study, revealed no significant differences between treatments.

CONCLUSIONS:

Racecadotril and loperamide were equally effective in treating acute diarrhoea in these children, and racecadotril had a superior tolerability and safety profile.

• Authors: D Turck, H Berard, N Fretault, J M Lecomte
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 13 Suppl 6 Pg. 27-32 (Dec 1999) ISSN: 0269-2813 [Print] England
• PMID: 10646049 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antidiarrheals
• Protease Inhibitors
• Loperamide
• racecadotril
• Thiorphan
• Neprilysin

Topics

• Acute Disease
• Antidiarrheals (therapeutic use)
• Child
• Child, Preschool
• Diarrhea (drug therapy)
• Double-Blind Method
• Female
• Humans
• Loperamide (adverse effects, therapeutic use)
• Male
• Neprilysin (antagonists & inhibitors)
• Protease Inhibitors (therapeutic use)
• Recurrence
• Thiorphan (adverse effects, analogs & derivatives, therapeutic use)