CHICAGO, May 9, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced the presentation of two abstracts at the 2011 Digestive Disease Week (DDW) conference highlighting additional analyses of data from Phase 3 trials of DIFICID™ (fidaxomicin), an investigational product for the treatment of Clostridium difficile infection (CDI).
The first analysis aimed to identify risk factors associated with early recurrence (a relapse within the first two weeks after end of therapy) compared to late recurrence (a relapse during the third and fourth weeks after end of therapy). Data presented by Kathleen Mullane, PharmD, D.O., Associate Professor of Medicine at The University of Chicago Department of Medicine, demonstrated that the majority of recurrences occurred within two weeks of completing initial therapy (129/190, 67.9%). Treatment with DIFICID was associated with a 66% reduction of early recurrence compared with vancomycin (7.4% vs 19.3%, p<0.001), and late recurrence was the same in both treatment arms. In addition, elevated white blood cell counts and low albumin levels at the end of treatment and exposure to concomitant antibiotics during the follow-up period were associated with a higher risk of late recurrence. The study titled "Risk of Recurrence and Time to Recurrence Following Treatment of Clostridium difficile Infection: Patient Characteristics and the Differential Effect of Fidaxomicin vs. Vancomycin," was presented on May 7.
"As many as 30 percent of patients initially treated for CDI will experience recurrent disease, or the persistence of CDI symptoms following initial treatment. This can cause significant loss of work productivity, keep people from their daily lives and, in some cases, cause repeated hospitalizations," said Dr. Mullane.