Key points from the evidence

The content of this evidence summary was up-to-date in July 2012. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information.

Fidaxomicin (Dificlir) is the first in a new class of macrocylic antibiotics and has recently been licensed by the European Medicines Agency (EMA) for the treatment of Clostridium difficile infection (CDI). Current Health Protection Agency (HPA) guidance recommends metronidazole as first-line therapy in mild to moderate CDI, but vancomycin in severe cases. Fidaxomicin has not been compared to metronidazole in clinical trials.

Evidence from two double-blind, randomised controlled trials indicates it is non-inferior to vancomycin in curing patients with mild to severe CDI. Its side-effect profile appears similar to that of oral vancomycin and it may have advantages in reducing the rate of recurrence.

When considering the use of fidaxomicin, local decision makers should take into account the potential benefits alongside the medical need, the risks of treatment, and the relatively high cost of fidaxomicin in comparison with other treatments for CDI.

Key evidence

Cornely OA, Crook DW, Esposito R, et al. (2012) Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infectious Diseases 12: 281–9

Louie TJ, Miller MA, Mullane KM et al. (2011) Fidaxomicin versus vancomycin for Clostridium difficile infection. New England Journal of Medicine 364: 422–31

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, but this summary is not NICE guidance.