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Clinical Infectious Diseases Publishes Subgroup Analysis Showing Optimer's DIFICID™ (fidaxomicin) Tablets Exhibited Higher Clinical Cure and Global Cure Rates Than Vancomycin in Patients with Clostridium difficile-Associated Diarrhea (CDAD) Receivin
Date:8/16/2011

60;Global cure rates were substantially reduced in both treatment groups when patients received concomitant antibiotics at any time, but 72.7% of DIFICID patients achieved global cure compared to 59.4% for vancomycin (p = 0.02). Concomitant antibiotic use was associated with higher recurrence rates in both the DIFICID and oral vancomycin treatment groups.  However, recurrence was consistently less frequent following DIFICID treatment whether patients received concomitant antibiotics or not. In patients receiving concomitant antibiotics at any time during treatment or follow-up, treatment with DIFICID was associated with a recurrence rate of 16.9% compared to 29.2% with oral vancomycin (p=0.048).

"Medical guidelines recommend discontinuation of concomitant antibiotics at the diagnosis of CDAD if possible. However, that may not always be practical because patients need the antibiotics for serious concurrent infections," said Dr. Sherwood Gorbach, Chief Scientific Officer at Optimer and an author on the study.  "To the extent treatments for CDAD can help mitigate the adverse impact of concomitant antibiotics on response to treatment, they would offer a much needed treatment option for this patient population."

Additional Study Details

Patients from two prospective, double-blind, randomized, noninferiority Phase 3 studies evaluating DIFICID and oral vancomycin in the treatment of CDAD were pooled for the subgroup analysis.

Of the 999 evaluable patients in the combined prospective studies, 275 patients (27.5%) received concomitant antibiotic therapy at some time during the treatment or follow-up course. Researchers analyzed the effect of concomitant antibiotic use on response rates for clinical cure, recurrence and global cure in CDAD patients, as well as compared the effects of DIFICID and oral vancomycin in the treatment of CDAD patients receiving concomitant antibiotics.

Patients were randomized to receive DIFICID (
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SOURCE Optimer Pharmaceuticals, Inc.
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