Use of Racecadotril as Outpatient Treatment for Acute Gastroenteritis: A Prospective, Randomized, Parallel Study

Santos, Mar; Marañón, Rafael; Miguez, Concepión; Vázquez, Patricia; Sánchez, César Sánchez

doi:10.1016/j.jpeds.2009.01.064

Cited by 38 publications

(56 citation statements)

References 24 publications

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“…There was no difference noted between the group on racecadotril and that on placebo for the outcomes measured. While this result is consistent with that seen by Santos et al 17 in their study carried out in 2009, it differs from most other studies carried out on the subject 78 18–20…”

Section: Discussionsupporting

confidence: 89%

Racecadotril for the treatment of severe acute watery diarrhoea in children admitted to a tertiary hospital in Kenya

Gharial¹,

Laving

Were

2017

BMJ Open Gastroenterol

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BackgroundDiarrhoea is the second most common cause of death in children under 5 years of age in Kenya. It is usually treated with oral rehydration, zinc and continued feeding. Racecadotril has been in use for over 2 decades; however, there is a paucity of data regarding its efficacy from Africa.ObjectivesThe objectives of this study were: to compare the number of stools in the first 48 hours in children with severe gastroenteritis requiring admission and treated with either racecadotril or placebo, to study the impact of racecadotril on duration of inpatient stay as well as duration of diarrhoea and to describe the side effect profile of racecadotril.MethodsThis was a randomised, double-blinded, placebo-controlled trial. It enrolled children between the age of 3 and 60 months who were admitted with severe acute gastroenteritis. They received either racecadotril or placebo in addition to oral rehydration solution (ORS) and zinc and were followed up daily.Results120 children were enrolled into the study. There were no differences in the demographics or outcomes between the 2 groups. Stools at 48 hours: median (IQR) of 5 (3–7) and 5 (2.5–7.5), respectively; p=0.63. The duration of inpatient stay: median (IQR): 4 days (1.5–6.5) and 4.5 (1.8–6.3); p=0.71. The duration of illness: 3 days (2–4) and 2 days (1–3); p=0.77. The relative risk of a severe adverse event was 3-fold higher in the drug group but was not statistically significant (95% CI 0.63 to 14.7); p=0.16.ConclusionsRacecadotril has no impact on the number of stools at 48 hours, the duration of hospital stay or the duration of diarrhoea in children admitted with severe gastroenteritis and managed with ORS and zinc.Trial registration numberPACTR201403000694398; Pre-results.

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Section: Discussionsupporting

confidence: 89%

Racecadotril for the treatment of severe acute watery diarrhoea in children admitted to a tertiary hospital in Kenya

Gharial¹,

Laving

Were

2017

BMJ Open Gastroenterol

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“…However, in view of some recently published studies with negative results, an update of these meta-analyses was recently performed; this update includes new data confirming that the use of Lactobacillus GG (Szajewska et al, unpublished data) or S. boulardii [14] is indeed associated with a reduction in the duration of diarrhea by approximately 1 day. [15]. The results of this study do not support the use of racecadotril for the management of AGE.…”

Section: Comparison Of Two Acute Gastroenteritis Guidelinescontrasting

confidence: 79%

Gastrointestinal infections in the pediatric population

Szajewska

Dziechciarz²

2010

Current Opinion in Gastroenterology

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“…This result is between the ranges published by controlled trials so far that have shown recovery times as short as seven hours and long as 97 hours, considering the controlled trials inconsistencies about the reporting outcomes. A recent systematic review24 carried out with the best randomized clinical trials about racecadotril efficacy showing recovery times of 6.9, 28, and 97 hours from active treatment groups of the main studies analyzed in this meta analysis 10,11,13. On the other hand, similar to results of the study by Cojocaru et al13 was published lately, another trial showing a diarrhea duration of four days in active treatment group.…”

Section: Discussionmentioning

confidence: 52%

Analysis of factors influencing the overall effect of racecadotril on childhood acute diarrhea. Results from a real-world and post-authorization surveillance study in Venezuela

Chacón¹

2010

TCRM

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Drug efficacy might differ from clinical trial results when performed in clinical daily conditions. Therefore, it is mandatory to conduct trials about effectiveness to improve external validity. This post-authorization, open-label, noncontrolled, prospective, multicenter, observational, and naturalistic trial was designed to search for factors influencing the racecadotril overall effect on childhood acute watery diarrhea in a real-world setting of Venezuela. There were 3,873 children with acute watery diarrhea treated with racecadotril, an enkephalin breakdown blocker plus oral rehydration therapy by 97 pediatricians. Evaluations were carried out daily until emission of two consecutive formed stools or absence of watery bowel movements for 24 hours. The primary end-point was time-to-relief, defined as the time from first racecadotril dose to the last watery bowel movement time. Age, gender, nursing type, nursing status during diarrhea, diarrhea severity, and co-medication were considered as factors in the statistical analysis. The primary end-point was evaluated by factors using UNIANOVA, and post-hoc tests were done. A multiple regression analysis was carried out to identify factors affecting drug performance, racecadotril effectiveness and tolerability overall assessment was searched by physicians and patients, and inter-observer agreement was evaluated by kappa statistics. The mean time-to-relief was 18.5 ± 12.5 hours [95% confidence interval 17.9–19.0] and the diarrhea severity was the only variable with significant and independent weight on racecadotril effectiveness explaining 23% of time-to-relief variance, but even in severe diarrhea cases this time was less than 24 hours. High agreement about satisfactory perception on effectiveness and tolerability was reached among physicians and patients. In conclusion, the racecadotril overall effect, evaluated in a real-world setting of Venezuela, was in agreement with results of some earlier controlled trials. It was only influenced by severity of diarrhea episode, as well as being considered an effective and well tolerated treatment by physicians and patients.

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Use of Racecadotril as Outpatient Treatment for Acute Gastroenteritis: A Prospective, Randomized, Parallel Study

Cited by 38 publications

References 24 publications

Racecadotril for the treatment of severe acute watery diarrhoea in children admitted to a tertiary hospital in Kenya

Racecadotril for the treatment of severe acute watery diarrhoea in children admitted to a tertiary hospital in Kenya

Gastrointestinal infections in the pediatric population

Analysis of factors influencing the overall effect of racecadotril on childhood acute diarrhea. Results from a real-world and post-authorization surveillance study in Venezuela

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