New Antibiotic Fights C. diff Infections
Study Shows Fidaxomicin Helps Treat Recurrent C. diff Infections
Fidaxomicin vs. Vancomycin
The rates of cure were similar -- 88.2% in the fidaxomicin and 85.8% with vancomycin.
But overall, fewer patients treated with fidaxomicin had another bout during the follow-up -- 13.3% vs. 24%.
However, when the researchers looked just at those who had the more virulent strain -- about a third of the patients -- they found the recurrence rates similar between the two medicines -- 24.4% for fidaxomicin and 23.6% for vancomycin.
That's not a worry, Gorbach tells WebMD. The new drug ''is no worse than vancomycin." And, he adds, research conducted after the clinical trial has found fidaxomicin can work better than vancomycin on the virulent strain.
When they looked at the non-virulent strains, however, less than 8% of those on fidaxomicin got another bout, compared to 25.5% of those on vancomycin.
Neither group had any serious side effects, Gorbach says.
Optimer has asked the FDA for fast-track approval, and the company is hoping for a decision on the drug's approval by May 30, Gorbach says.
''This is a major advance," says Mitchell B. Cohen, MD, director of gastroenterology, hepatology, and nutrition at Cincinnati Children's Hospital Medical Center, who has researched the topic but was not involved in the new drug study.
''The question of course is, will the bugs get smart and figure out how to up the ante and get around this advance, or will this [effect] be more or less sustained?"