Dificlir success in reduction of recurrence in Clostridium difficile

A report in The Lancet Infectious Diseases shows that Dificlir (fidaxomicin) from Optimer Pharma has a similar efficacy and tolerability profile for Clostridium difficile infection (CDI) compared with the current standard therapy oral vancomycin. However, the sustained response of Dificlir is superior with a larger rate of recurrence reduction. 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. The study showed 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<0.001) amongst the vancomycin group. the researchers also observed that 76.6 p="0.001)" of patients in the dificlir group tended to have a sustained response i.e. clinical cure without recurrence within 30 days after completion of therapy as compared with 63.4 of patients in the placebo group. see the lancet infectious diseases volume 12 issue 4 pages 281 - 289 april 2012 doi:10.1016 s1473-30991170374-7 published online: 08 february 2012 -fidaxomicin versus vancomycin for infection with clostridium difficile in europe canada and the usa: a double-blind non-inferiority randomised controlled trial- prof oliver a cornely md prof derrick w crook md prof roberto esposito md andr poirier md michael s somero md prof karl weiss md pamela sears phd prof sherwood gorbach md for the opt-80-004 clinical study group.>