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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

s in patients within the first 12 days following initiation of treatment but also significantly reduced persistent diarrhea, disease recurrence or death through day 40 of the study."

The analysis was independently funded by the NIHR Biomedical Research Centre, Oxford, a research partnership between the Oxford Radcliffe Hospitals and the University of Oxford.

Study Methods

The analysis was performed using data from two prospective, randomized, double-blinded, non-inferiority Phase 3 studies evaluating DIFICID and oral vancomycin in the treatment of CDAD in adults 18 years of age or older. A non-inferiority design was utilized to demonstrate the efficacy of DIFICID (200 mg orally twice daily for 10 days) compared to vancomycin (125 mg orally four times daily for 10 days) in adults with CDAD. The studies enrolled a total of 1,164 adults with confirmed CDAD. The primary objective of both studies was to show that a 10-day course of DIFICID was as effective as oral vancomycin in achieving a clinical cure at the end of therapy. Clinical cure was defined as resolution of diarrhea (no more than 3 unformed stools for 2 consecutive days) maintained for the duration of therapy with no further requirement for therapy assessed two days after the end of the 10 day treatment. Subjects meeting the criteria for clinical cure were followed for 28 days after the end of treatment (36-40 days after randomization) and assessed for the additional efficacy endpoints of recurrence and global cure. Recurrence was defined by the reappearance of more than 3 unformed stools in any 24-hour period with C. difficile toxin A or B or both detected and a need for retreatment.  Global cure was defined as clinical cure without recurrence.  

To compile the results, researchers conducted a post-hoc exploratory analysis to determine the time-to-event for a composite endpoint of persistent diarrhea, disease recurrence or death of the combined intent-to-tre
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SOURCE Optimer Pharmaceuticals, Inc.
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