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Comparison of racecadotril and loperamide in children with acute diarrhoea
Author(s) -
Turck D.,
Berard H.,
Fretault N.,
Lecomte J.M.
Publication year - 1999
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1999.00004.x-i1
Subject(s) - loperamide , medicine , tolerability , placebo , adverse effect , gastroenterology , concomitant , diarrhea , constipation , anesthesia , alternative medicine , pathology
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.