The content of this evidence summary was up-to-date in March 2013. See summaries of product characteristics (SPCs), British national formulary (BNF), BNF for children (BNFc) or the MHRA or NICE websites for up-to-date information.

Key points from the evidence

Racecadotril (Hidrasec) received a UK marketing authorisation in September 2011 and was launched in the UK in October 2012. It has been licensed in parts of Europe for some time, for example in France for more than 20 years.

Racecadotril is licensed for the complementary symptomatic treatment of acute diarrhoea in infants (aged over 3 months) and in children, together with oral rehydration and the usual support measures (dietary advice and increased daily fluid intake), when these measures alone are insufficient to control the clinical condition. It is also licensed for the symptomatic treatment of acute diarrhoea in adults, which is the subject of a separate evidence summary.

A meta-analysis (9 studies, n=1384) in children (median age 12 months) with acute diarrhoea has shown that racecadotril in combination with ORS solution statistically significantly reduces the duration of diarrhoea and the volume and frequency of stool output, and increases the proportion of children who recover within 2 days, compared with ORS solution alone or with placebo. The median duration of diarrhoea was 1.75 days in the racecadotril group and 2.81 days in the comparator group (p<0.001). Four children would need to be treated with racecadotril rather than placebo for 1 extra child to recover in 2 days. It is unclear from this meta‑analysis whether racecadotril reduces the risk of further inpatient or outpatient visits, or the need for intravenous rehydration.

The number of adverse events did not differ significantly between the groups. 11.6% of children in the racecadotril group had an adverse event compared with 10.1% in the comparator group (p value not stated).

The meta-analysis has several limitations and limited applicability to UK practice, particularly primary care. The majority of children in the UK recover from acute diarrhoea without treatment or by using ORS solution alone. Although adjunctive therapy with racecadotril appears to be effective and well tolerated, it is unclear which children would benefit from it and whether it is cost effective.

A UK cost-effectiveness analysis (Rautenberg et al. 2012) has been published. It is not discussed here because cost-effectiveness analyses are outside the scope for Evidence summaries: new medicines.

In December 2012, the Scottish Medicines Consortium did not recommend racecadotril for use in children in NHS Scotland. Having considered 3 studies carried out in Europe (which were included in the meta-analysis discussed in this evidence summary) it concluded that the clinical and economic analysis presented by Abbott Healthcare Products Limited was not sufficiently robust to gain acceptance.

Diarrhoea and vomiting caused by gastroenteritis: diagnosis, assessment and management in children younger than 5 years (NICE clinical guideline 84) covers diagnosis of gastroenteritis, assessment of dehydration, fluid management, nutritional management and the role of antibiotics and other therapies. Low-osmolarity oral rehydration salt (ORS) solution is recommended for children with dehydration and those at risk of dehydration. The guideline does not recommend using antidiarrhoeal drugs.

Local decision makers will need to consider the available evidence when making decisions about using racecadotril.

Key evidence

Lehert P, Chéron G, Calatayud GA et al. (2011) Racecadotril for childhood gastroenteritis: an individual patient data meta-analysis. Digestive and Liver Disease 43: 707–13

About this evidence summary

'Evidence summaries: new medicines' provide summaries of key evidence for selected new medicines, or for existing medicines with new indications or formulations, that are considered to be of significance to the NHS. The strengths and weaknesses of the relevant evidence are critically reviewed within this summary to provide useful information for those working on the managed entry of new medicines for the NHS, but this summary is not NICE guidance.