Tiorfan em crianças

GASTROENTEROLOGY 2001;120:799 – 805

Efficacy and Tolerability of Racecadotril in Acute Diarrhea in Children
´
JEAN PIERRE CEZARD,* JEAN FRANCOIS DUHAMEL,‡ MARTINE MEYER,§ ISABELLE PHARAON,*
¸
MARC BELLAICHE, CHANTAL MAURAGE,¶ JEAN LOUIS GINIES,# JEAN MICHEL VAILLANT,**
JEAN PHILIPPE GIRARDET,* THIERRY LAMIREAU,‡‡ ALAIN POUJOL,§§ ALAIN MORALI,
JACQUES SARLES,¶¶ JEAN PIERRE OLIVES,## CAROLINE WHATELY–SMITH,*** SYLVIE AUDRAIN,‡‡‡ and JEANNE MARIE LECOMTE†††
*Pediatric Gastroenterology Unit, Paris, France; ‡Caen, France; §Clermont-Ferrand, France; Versailles, France; ¶Tours, France;
#Angers, France; **Lisieux, France; ‡‡Bordeaux, France; §§Aix en Provence, France; Nancy, France; ¶¶Marseille, France; ##Toulouse, France;
***SmithKline Beecham International, London, England; and †††Laboratoire Bioprojet, Paris, France

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