CHICAGO, May 9, 2011 /PRNewswire/ — Optimer Pharmaceuticals,
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.