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New Analysis Shows Age has a Significant Effect on Outcomes in Patients Being Treated for Clostridium difficile Infection (CDI)
Date:2/14/2013

nd other factors that may impact treatment outcome, including the administration of concomitant antibiotics and C. difficile strain, DIFICID was associated with a 60% lower risk of recurrence (p<0.001) compared to vancomycin.

"This analysis reinforces the serious consequences of CDI for patients as they get older, including significantly increased risk of disease recurrence and treatment failure, " said Sherwood L. Gorbach , M.D., co-author and Optimer's Chief Scientific Officer and Senior Vice President. "Most notably, results showed that the decline in treatment outcomes can begin as early as age 40, which suggests that age is an important risk factor for patients."

About the Analysis
The analysis was based on two multi-center, randomized, double-blind Phase 3 clinical trials, which enrolled 1,164 adult patients throughout Europe and North America. Patients with confirmed CDI,  received either 200 mg of DIFICID (fidaxomicin) tablets dosed orally twice daily or 125 mg of vancomycin dosed orally four times daily for 10 days.  

CDI was defined by a change in bowel habits, with more than three unformed bowel movements (or >200 mL unformed stool for patients with rectal collection devices) in the 24 hours before randomization, and the presence of either toxin A or B of C. difficile in the stool within 48 hours of randomization. The primary endpoint of the study was non-inferiority in clinical cure, which was defined as resolution of diarrhea (no more than three unformed stools for two consecutive days) maintained until the end of therapy for two days after. Patients who achieved a clinical cure were monitored for a subsequent four-week period to evaluate recurrence, which was a secondary endpoint.  Sustained clinical response, an additional endpoint, was defined as patients who achieved clinical cure and did not experience a recu
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SOURCE Optimer Pharmaceuticals, Inc.
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