Effet du racécadotril sur le recours aux soins dans le traitement des diarrhées aiguës du nourrisson et de lˈenfant

Cojocaru, B; Bocquet, N.; Timsit, S.; Wille, Clara; Boursiquot, C; Marcombes, F; Garel, D; Sannier, N.; Chéron, G.

doi:10.1016/s0929-693x(01)00988-5

Cited by 37 publications

(28 citation statements)

References 19 publications

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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: Discussionsupporting

confidence: 52%

“…Racecadotril efficacy has been proven in developed and developing countries as a treatment for acute childhood diarrhea in controlled clinical trials,9–13 which are considered the best standard to prove drug efficacy. However, performance in daily practice, ie, effectiveness, has not been researched so far.…”

Section: Discussionmentioning

confidence: 99%

“…This is why there is a great variability in operational definition across clinical trials. Racecadotril controlled trials, using different operational diarrhea approaches, have shown recovery times ranging between 6.9 hours and 97.2 hours 10–13. On the other hand, a large community study carried out in Brazil showed a diarrhea mean time of 69.6 hours in 2,403 diarrhea episodes suffered by 1,156 children managed at home 22.…”

Section: Discussionmentioning

confidence: 99%

“…Racecadotril, a pro-drug metabolized to thiorphan, its active metabolite, is an enkephalin breakdown blocking agent which inhibits intestinal hypersecretion in acute watery diarrhea and whose efficacy and safety has been proven in European and Latin-American countries in controlled clinical trials 9–13. To our knowledge racecadotril performance in a real world setting, having taken into account factors affecting its effectiveness, has not been studied so far.…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionsupporting

confidence: 52%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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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“…However, there is no new clinical efficacy data available since the original model was published; therefore, it is acceptable that this data has remained the same for the adaptation. As before, the reader should consider that the nine studies used for the Lehert meta-analysis18 (and in the model) were undertaken in France (two),10,11 Spain (two),12,13 Peru,14 India,15 Mexico (two studies)16 and Guatemala 17. The external validity of the clinical data will depend on how closely the above countries represent the health care system in Thailand.…”

Section: Discussion and Limitationsmentioning

confidence: 99%

The cost utility and budget impact of adjuvant racecadotril for acute diarrhea in children in Thailand

Rautenberg¹,

Zerwes

2017

CEOR

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ObjectiveTo evaluate the cost utility and the budget impact of adjuvant racecadotril for the treatment of acute diarrhea in children in Thailand.MethodsA cost utility model has been adapted to the context of Thailand to evaluate racecadotril plus oral rehydration solution (R+ORS) versus oral rehydration solution (ORS) alone for acute diarrhea in children <5 years old. The decision tree Excel model evaluates the costs and effects (quality-adjusted life years) over a 6-day time horizon from a public health care payer’s perspective in Thailand. Deterministic sensitivity analysis and budget impact analysis have been undertaken.ResultsAccording to the cost utility model, the intervention (R+ORS) is less costly and more effective than the comparator (ORS) for the base case with a dominant incremental cost-effectiveness ratio of −2,481,390฿ for the intervention. According to the budget impact analysis (assuming an increase of 5% market share for R+ORS over 5 years), the year-on-year reduction for diarrhea as a percentage of the total health care expenditure is −0.0027%, resulting in potential net cost savings of −35,632,482฿ over 5 years.ConclusionSubject to the assumptions and limitations of the models, adjuvant racecadotril versus ORS alone is potentially cost-effective for children in Thailand and uptake could translate into savings for the Thailand public health care system.

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Racecadotril for acute diarrhoea in children

Liang

Zhang

Zeng

et al. 2019

Cochrane Database of Systematic Reviews

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BackgroundAcute diarrhoea is a leading cause of death for children under five years of age. Most deaths are caused by excessive fluid and electrolyte losses. Racecadotril is an anti‐secretory drug that has been used for acute diarrhoea in children as an adjunct to oral rehydration therapy.ObjectivesTo assess the efficacy and safety of racecadotril for treating acute diarrhoea in children under five years of age.Search methodsWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL, published in the Cochrane Library Issue 3, March 2019); MEDLINE; Embase; LILACS; ClinicalTrials.gov; and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), up to 4 March 2019, for clinical trials regardless of publication language or status.Selection criteriaRandomized controlled trials (RCTs) that compared racecadotril to placebo or no intervention in addition to standard care (oral rehydration therapy) in children under five with acute diarrhoea. The primary outcomes were failure of oral rehydration, duration of diarrhoea, and number of stools. The secondary outcomes were stool output, length of the hospital stay, and adverse events.Data collection and analysisTwo review authors independently assessed trial eligibility, extracted the data and assessed risk of bias. We presented dichotomous data with risk ratios (RR) and continuous data with mean difference (MD) or standardized mean difference (SMD). Where appropriate, we combined trials with meta‐analysis and used a random‐effects model if there was significant heterogeneity (I² ≥ 50%). We assessed the certainty of the evidence using the GRADE approach.Main resultsSeven RCTs with a total of 1140 participants met the inclusion criteria. The trials were carried out on children aged three months to five years, in outpatient and inpatient facilities from France, Spain, Peru, India, Kenya, and Ecuador. The efficacy and safety of racecadotril were compared to placebo or no treatment. Racecadotril may reduce the risk of rehydration failure (RR 0.41, 95% CI 0.13 to 1.23; 2 RCTs, 192 participants; low‐certainty evidence). Data on duration of diarrhoea, number of stools in the first 48 hours are insufficient to reach a conclusion; stool output in the first 48 hours appears to be lower in the two trials measuring this, although the data is not combinable. Length of hospital stay was similar in two studies measuring this, and overall there was no evidence that racecadotril increased overall rate of adverse events (RR 0.90, 95% CI 0.66 to 1.22; 5 RCTs, 688 participants; low‐certainty evidence). Most adverse events in the racecadotril group were mild or moderate.Authors' conclusionsRacecadotril seems to be a safe drug but has little benefit in improving acute diarrhoea in children under five years of age. Current evidence does not support routine use of racecadotril in management of acute diarrhoea in children under five outside of the context of placebo controlled RCTs.

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Effet du racécadotril sur le recours aux soins dans le traitement des diarrhées aiguës du nourrisson et de lˈenfant

Cited by 37 publications

References 19 publications

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

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

The cost utility and budget impact of adjuvant racecadotril for acute diarrhea in children in Thailand

Racecadotril for acute diarrhoea in children

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