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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

rrence of symptomatic CDI by the end-of-study visit.  The modified intent-to-treat population (mITT) was comprised of patients with documented CDI who received at least one dose of study medication (n=1,105).  The per protocol population was comprised of patients in the mITT group with at least three days of treatment (for failure) or at least eight days of treatment (for cure), documented adherence to protocol, and an end-of-therapy evaluation (n=999).

Researchers used logistic regression models (SAS, Cary, NC) to test the effects of age, study (NCT00314951 or NCT00468728) and treatment group (DIFICID or vancomycin) on clinical cure, sustained clinical response and disease recurrence. Patient data was stratified as inclusive age categories: <40, 41-50, 51-60, 61-70, 71-80 and >80 years. The relationship of age or treatment group to clinical cure, sustained clinical response and disease recurrence was determined using Chi-square tests. Odds ratios, 95% confidence intervals and P values were determined. A P value of <0.05 was considered significant. Multiple regression analysis of all other risk factors found to have a statistically significant association (p< 0.1) to outcomes was performed.

About Clostridium difficile Infection (CDI)
Clostridium difficile infection (CDI) is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death.  Clostridium difficile-associated diarrhea is the most common symptom of CDI.  In recent years, C. difficile has surpassed methicillin-resistant Staphylococcus aureus (MRSA) as the leading cause of healthcare-acquired infections in community hospitals.  Patients typically develop CDAD from the use
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SOURCE Optimer Pharmaceuticals, Inc.
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