Fidaxomicin better than oral vancomycin for clostridium difficile infection

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