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Fidaxomicin bested vancomycin in early recurrent C. difficile infection
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Fidaxomicin was associated with a lower rate for early recurrence of Clostridium difficile infection within 2 weeks of treatment compared with vancomycin, according to data presented at the 2011 Digestive Disease Week.
Yoav Golan, MD, MS, assistant professor of medicine at Tufts Medical Center, and colleagues set out to assess risk factors for recurrent C. difficile infection; compare early vs. late recurrence of infection; and assess the effect of fidaxomicin (Optimer Pharmaceuticals) vs. vancomycin for the prevention of early vs. late recurrence of infection.
For the phase 3 clinical trial, 518 adults with symptoms associated with C. difficile infection and a positive toxin test were assigned oral fidaxomicin (n=253) or vancomycin (n=265) for 10 days.
Overall, 20.5% patients had recurrent C. difficile infection. Researchers observed consistencies in the distribution of recurrences within the first 2 weeks after stopping initial therapy (early; 10.5 recurrences per 1,000 patient-days) and within 2 to 4 weeks after stopping initial therapy (late; five recurrences per 1,000 patient-days).
Compared with vancomycin, fidaxomicin was associated with a lower rate for early recurrence (15.1 recurrences per 1,000 patient-days vs. 5.9 recurrences per 1,000 patient-days; P<.001). No difference was observed between treatments in the rate of recurrence during weeks 3 and 4 of follow-up, according to the study abstract.
“This differential effect is likely due to a less deleterious effect of fidaxomicin on normal fecal microflora,” the researchers wrote in the abstract. “Late recurrence is likely related to a new infection and is affected by patient-related factors, not initial treatment choices. Such factors may define a group at high risk for new infection and could guide prevention measures and treatment choices.”
Disclosures: Dr. Golan reports no disclosures.
For more information:
- Golan Y. Presented at: Digestive Disease Week 2011; May 7-10; Chicago.
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