Relevance to NICE guidance programmes
Racecadotril was not considered appropriate for a NICE technology appraisal and is not currently planned into any other NICE work programme.
The NICE clinical guideline on diarrhoea and vomiting in children under 5 was published in 2009. The Guideline Development Group reviewed 2 randomised placebo-controlled trials that looked at the effectiveness of racecadotril for treating diarrhoea in children. One of the studies was carried out in a single centre in Peru (Salazar-Lindo et al. 2000, n=135) and the other was carried out in 13 centres in France (Cézard et al. 2001, n=172). The studies found that children under 4 years who were given racecadotril (1.5 mg/kg 3 times daily) and oral rehydration salt (ORS) solution had a statistically significantly reduced total and average hourly stool output 48 hours after starting treatment compared with children given placebo and ORS solution. The Guideline Development Group concluded that, at that time, there was evidence that racecadotril had an antidiarrhoeal effect but further research was needed to examine the possible clinical and health economic benefits that might be associated with its use in the UK.
The highest quality published evidence available at the end of 2012 is discussed in this evidence summary. Although a UK cost-effectiveness analysis (Rautenberg et al. 2012) has been published, it is not discussed here because cost effectiveness is outside the scope of Evidence summaries: new medicines.