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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

SAN DIEGO, Aug. 16, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that a subgroup analysis of patients receiving concomitant systemic antibiotics in two Phase 3 clinical trials exploring the use of DIFICID™ (fidaxomicin) tablets in the treatment of adult patients with Clostridium difficile-associated diarrhea (CDAD) was published online in the September 1 issue of Clinical Infectious Diseases (CID). The analysis found that in the presence of concomitant systemic antibiotic therapy, which is the use of antibiotics to treat concurrent infections, DIFICID achieved a significantly higher initial clinical cure rate, and higher rate of global cure, compared to oral vancomycin. In the article, approximately 28% of patients in the Phase 3 clinical trials required antibiotic treatment for concurrent infections, primarily lung and urinary tract, and these treatments had an adverse impact on the efficacy of both CDAD therapies.

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Patients with CDAD who received DIFICID while taking concomitant antibiotics demonstrated a significantly higher clinical cure rate of CDAD than patients who received oral vancomycin and concomitant antibiotics (90.0% clinical cure rate vs. 79.4%, respectively; p=0.04).Regardless of concomitant antibiotic use, DIFICID was also statistically superior to oral vancomycin in global cure rate. Global cure is defined as clinical cure with no recurrence through the end of study visit 26 to 30 days after completion of CDAD treatment.

"To date, there has been little research demonstrating the impact of concomitant antibiotic use in patients being treated for CDAD," said Dr. Kathleen Mullane, Associate Professor of Medicine at The University of Chicago Department of M
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SOURCE Optimer Pharmaceuticals, Inc.
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