New guidelines recommend Fixaxomicin

CDI is one of the most common causes of antibiotic-associated diarrhoea and severe cases can lead to bowel surgery and even death.[4] Hospital patients with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.[5,6] Recurrence is a major challenge in CDI treatment. 25% of CDI patients suffer a recurrence within one month[7–9] and patients who have already had one recurrence have a 40% risk of a further episode of CDI.[10]

“One of the biggest challenges to optimal CDI management is recurrence, therefore the significant reduction in disease recurrence by DIFICLIR compared with vancomycin is an important step in reducing the morbidity and mortality associated with CDI”, comments Professor Oliver Cornely, University Hospital Cologne, Germany. “I welcome these guidelines and believe implementation of the recommendations will help to improve CDI care and reduce the burden on both patients and healthcare systems”.

Two large Phase III clinical studies comparing the efficacy and safety of 400mg/day oral fidaxomicin with 500mg/day oral vancomycin showed potential advantages of fidaxomicin over vancomycin, the standard of care.[9,11] Patients were eligible to participate in these trials with a confirmed diagnosis of CDI and included patients who were classified as having severe CDI as well as patients for whom CDI is an especial risk such as those patients who were elderly[11] or had concomitant diseases.[12–14]

Fidaxomicin significantly reduced the rate of CDI recurrence as compared with vancomycin, with patients treated with fidaxomicin significantly more likely than those receiving vancomycin to experience diarrhoea resolution without recurrence within 30 days of therapy completion.[9,11] Fidaxomicin also met its primary endpoint of clinical cure rate, which was equivalent to that of vancomycin.[9,11]

Certain populations are at higher risk of CDI and are particularly vulnerable. CDI can be associated with a mortality rate as high as 14% in elderly patients[15] and hospitalised cancer patients treated for CDI experience longer hospital stays.[16] Progressive chronic kidney disease is associated with increased time to resolution of diarrhoea, lower cure rates, and higher incidence of recurrence in patients treated for CDI.[14]

Patients in long term care facilities are particularly at risk and CDI recurrence rates can be as high as 50% over a six-month period when acquired in a long term care facility.[17] Mortality rates in intensive care unit patients over the age of 65 years have been reported to be as high as 45%.[18] In line with the revised ESCMID treatment guidance document DIFICLIR is recommended for patients who are suitable for oral antibiotic treatment in these vulnerable patient sub-populations.

“CDI is potentially fatal and has a major impact on patients’ health and quality of life. We hope adherence to these recommendations will lead to better management of CDI and the treatment of recurrence”, said Ken Jones, President and CEO of Astellas Pharma Europe Ltd.

The previous ESCMID guidance document was issued in 2009[19] and has been widely applied in clinical practice. However, as new CDI treatments have been developed an update of this document was necessary to further improve uniformity of national CDI treatment policies in hospitals across Europe. To produce the updated guidelines, ESCMID and a team of experts from 11 European countries ran a computerised literature search to review randomised and non-randomised trials investigating the effect of an intervention on the clinical outcome of CDI. The revised 2013 guidelines provide an overview of currently available CDI treatment options and evidence-based recommendations on the treatment of CDI.[3]