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Comparison of racecadotril and loperamide in children with acute diarrhoea
D Turck1, H Berard, N Fretault
1Hôpital Jeanne de Flandre, Lille, Paris, France. dturck@chru-lille.fr
Insights
Racecadotril and loperamide showed equal effectiveness for acute diarrhea in children. Racecadotril demonstrated a better safety and tolerability profile, with fewer adverse events and less constipation.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
Background:
- Acute diarrhea is a common pediatric illness.
- Effective and safe treatment options are crucial for managing pediatric diarrhea.
Purpose of the Study:
- To compare the efficacy, tolerability, and safety of racecadotril versus loperamide in children with acute diarrhea.
- To evaluate treatment outcomes including stool frequency, duration of diarrhea, and adverse events.
Main Methods:
- A multicenter, double-blind, double-placebo study.
- Involved 102 children aged 2-10 years with acute diarrhea.
- Patients received either racecadotril or loperamide three times daily until recovery.
Main Results:
- Both racecadotril and loperamide were equally effective in treating acute diarrhea.
- Racecadotril showed a lower incidence of adverse events (11.5% vs. 22%) and significantly less constipation (36.5% vs. 58%) compared to loperamide.
- Fewer children on racecadotril required concomitant medication (19.2% vs. 38%).
Conclusions:
- Racecadotril and loperamide are equally effective for acute diarrhea in children.
- Racecadotril offers a superior safety and tolerability profile compared to loperamide in this pediatric population.
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.