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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

edicine and an author on the study. "Results from this subgroup analysis show that more than one in four patients with CDAD were also taking concomitant antibiotics for other infections and that concomitant antibiotic therapy can significantly compromise CDAD treatment. The results also suggest that DIFICID may help blunt the effect of concomitant antibiotics on response to CDAD treatment and that continued investigation of the impact of concomitant antibiotic use in this patient population is warranted."

Effect of Concomitant Antibiotic Use on Clinical Outcomes

Among patients analyzed in the study, the use of concomitant antibiotics compromised response to CDAD therapy. For the combined DIFICID and vancomycin treatment groups, CDAD patients who received concomitant antibiotics had clinical cure rates of 84.4%, compared to cure rates of 92.6% among patients who did not (p<0.001), and experienced a median extended time to resolution of diarrhea of 97 hours compared to 54 hours in patients who did not receive additional antibiotics (p<0.001).  Global cure was observed in 74.7% of patients who did not receive concomitant antibiotics compared to 65.8% of patients receiving concomitants antibiotics at any time during the study (p= 0.005). Use of concomitant antibiotics tended to increase the rate of recurrence but did not reach significance.

Effect of DIFICID vs. Vancomycin with Concomitant Antibiotics

In the absence of concomitant antibiotic use, DIFICID and vancomycin were similar in achievement of clinical cure by the end of treatment (92.3% vs. 92.8%; p= 0.80). However, when patients received one or more antibiotics concurrently with study drug, DIFICID was superior to vancomycin in achieving clinical cure (90.0% vs. 79.4% p = 0.04). When patients received no additional antibiotics at any time during the study, the global cure rate was 80.8% for DIFICID patients and 69.1% for vancomycin patients(p < 0.001). 
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SOURCE Optimer Pharmaceuticals, Inc.
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