Comparison of racecadotril and loperamide in children with acute diarrhoea.
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.
Turck
D
D
Hôpital Jeanne de Flandre, Lille, Paris, France. dturck@chru-lille.fr
Berard
H
H
Fretault
N
N
Lecomte
J M
JM
D000208:Acute Disease; D000930:Antidiarrheals / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008139:Loperamide / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D015260:Neprilysin / Q000037:antagonists & inhibitors*; D011480:Protease Inhibitors / Q000627:therapeutic use*; D012008:Recurrence; D015244:Thiorphan / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000930:Antidiarrheals; D011480:Protease Inhibitors; D008139:Loperamide; C049331:racecadotril; D015244:Thiorphan; D015260:Neprilysin