CDI (C. difficile infection), a serious illness caused by C. difficile bacteria infecting the colon’s internal lining, commonly occurs in patients who have used broad-spectrum antibiotics that disrupt the normal bowel flora so that the C. difficile bacteria, which produce toxins that cause colon inflammation, diarrhea and in severe cases bowel surgery and even death, can flourish.

Patients aged 65 years or older are particularly at risk of CDI and disease recurrence. The disease is a substantial problem in nursing homes, hospitals and other long-term facilities, and one of the most common healthcare-acquired infections in the E.U., posing a substantial burden on the healthcare system, as patients on average require an extra 3.6 days in hospital and have a 54% higher adjusted hospital cost than patients without CDI.

The latest issue of The Lancet Infectious Diseases shows that DIFICLIR (fidaxomicin) has a similar efficacy and tolerability profile compared with the current standard therapy for CDI, oral vancomycin; however, the sustained response is superior with a larger rate of recurrence reduction.

With current therapies, CDI recurs in up to 25% of patients within 30 days of initial treatment, which, according to The European Society of Clinical Microbiology and Infectious Diseases (ESCMID), is the most important problem in the treatment of CDI.

Researchers have evaluated the efficacy and tolerability of DIFICLIR in a multi-center, double blind, randomized, non-inferiority Phase III trial (Study OPT-80-004), by administering 509 adults with CDI in seven European countries and North America with either 400mg/day oral DIFICLIR or 500mg/day oral vancomycin for a period of 10 days.

They observed similar rates of clinical cure in patients between both treatments, which meant that DIFICLIR met its primary endpoint of being non-inferior to vancomycin. The study outcome also demonstrates that DIFICLIR has potential advantages over vancomycin in terms of recurrence and sustained response, with a CDI recurrence within 30 days after completing the therapy being substantially lower amongst the DIFICLIR group, i.e. 12.7% as compared with 26.9% (p

Leading researcher, Professor Oliver Cornely, Medical Director of the Clinical Trial Center of The University of Cologne in Germany explained:

“CDI is a significant and growing problem in hospitals and care homes. The high percentage of patients experiencing CDI recurrence remains one of the biggest barriers to improving the management of this severe and sometimes life-threatening condition. In this study, DIFICLIR significantly reduced disease recurrence compared to vancomycin, the current standard of care, showing real promise as an effective treatment alternative for patients with CDI.”

The trial took pace in Belgium, France, Germany, Italy, North America, Spain, Sweden and the United Kingdom and is the second of two identically designed Phase III trials that compared DIFICLIR and vancomycin in patients with CDI. The sister trial that was performed in the U.S. and Canada called Study OPT-80- 003 demonstrated the same outcome to the European trial Study OPT-80-004.

Ken Jones, President and CEO of Astellas Pharma Europe Ltd remarked:

“There is a clear need for new treatment advances to reduce the impact of this distressing and widespread disease. The results of this study reinforce the strong data we have already seen for DIFICLIR and support its position as a new and exciting treatment option for CDI.”

In the U.S. DIFICLIR is marketed as DIFICID™. Designed and developed by Optimer Pharmaceuticals, Inc., DIFICLIR was approved by the US Food and Drug Administration in May 2011 and was approved to be marketed in Europe in December 2011 for the treatment of adults with CDI, also known as C. difficile-associated diarrhea (CDAD). The exclusive licensee for the development and marketing of DIFICLIR in Europe and countries in the Middle Ease, Africa and the Commonwealth of Independent States is Astellas Pharma Europe Ltd.

Written by Petra Rattue