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DIFICID™ Demonstrated Early Superiority in the First 12 Days Compared to Vancomycin in New Analysis of Phase 3 Study Results
Date:10/20/2011

at (ITT) population from the two randomized Phase 3 studies. Researchers used fixed-effects meta-analysis and Cox regression models to complete the analysis, fixing the time of the 8-12 day primary end of therapy assessment utilized in the clinical trials at 12 days.

Additional Study Results

In the two Phase 3 studies, DIFICID achieved clinical cure rates at the end of treatment that were non-inferior to oral vancomycin and lower recurrence rates that were statistically significant. In the ITT analysis, the superior reduction in persistent diarrhea or death seen at day 12 for DIFICID (p=0.037) was driven by 7 deaths among DIFICID-treated patients (1.2%) compared to 17 (2.9%) deaths among patients who received vancomycin (exact p=0.06). The overall analysis demonstrated a 40% reduction in persistent diarrhea, disease recurrence or death (all causes) compared to vancomycin through day 40 of the study (95% CI: 26-51%; p<0.0001).

Results of the ITT combined analysis also show that randomization to DIFICID in the Phase 3 clinical studies reduced the risk of persistent diarrhea, recurrence or death by 52% (95% CI: 37-63%; p<0.0001), even after adjusting for other factors. Persistent diarrhea or death in the first 12 days following initiation of treatment was most strongly predicted by previous anti-CDAD antibiotic use in the 24 hours prior to randomization (p=0.0001) and low baseline eosinophils (p=0.007) and/or albumin (p<0.0001) at randomization. Patients with CDAD in the three months prior to entering the study had a 68% higher risk of recurrence or death during study days 13-40. Through 40 days, there was no evidence that the benefits of DIFICID over vancomycin varied according to disease severity, prior history of CDAD, previous anti-CDAD antibiotics, inpatient versus outpatient, patient age, baseline albumin or baseline creatinine levels.

About CDAD

Clostridium difficile-associated diarrhea (CDAD) ha
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SOURCE Optimer Pharmaceuticals, Inc.
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