New Analysis Shows Age has a Significant Effect on Outcomes in Patients Being
Treated for Clostridium difficile Infection (CDI)
- Results published in Journal of the American Geriatrics Society demonstrate
continuous declines in clinical cure and sustained clinical response after age
JERSEY CITY, N.J., Feb. 14, 2013
JERSEY CITY, N.J., Feb. 14, 2013 /PRNewswire/ --Optimer Pharmaceuticals, Inc.
(Nasdaq: OPTR) today announced that the February 2013 Journal of the American
Geriatrics Society published results from a multivariate analysis
demonstrating that advancing age is a predictor of deterioration in treatment
outcomes in patients with Clostridium difficile infection (CDI). The analysis
was performed using data from two large, randomized Phase 3 clinical studies
that compared the efficacy of DIFICID® (fidaxomicin) tablets to vancomycin for
the treatment of CDI. The new analysis predicts that with each decade increase
after the age of 40, rates of clinical cure and sustained clinical response
decrease by 17% and 13% with treatment, respectively, per decade (OR=0.83, 95%
CI [0.72, 0.95], p=0.008; and OR=0.87, 95% CI [0.79, 0.94], p<0.001), while
rates of disease recurrence increase by 17% (OR=1.17, 95% CI [1.04, 1.30],
Results of the analysis showed that DIFICID and vancomycin were comparably
effective in attaining clinical cure in all age groups studied; in those
younger than 40 years of age, clinical cure was achieved in 97.2% of patients
and in those older than 80, clinical cure was achieved in 87.5% to 88.2% of
patients. For patients who achieved clinical cure, DIFICID-treated patients
were half as likely to have had a recurrence compared to patients treated with
vancomycin (OR=0.46, 95% CI [0.32, 0.67], p<0.001). The analysis showed the
probability of sustained clinical response nearly doubled among
DIFICID-treated patients compared to patients who received vancomycin
(OR=1.86, 95% CI [1.40, 2.47], p<0.001). When researchers conducted an
analysis adjusting for age and 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 recurrence 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
AboutClostridium difficile Infection (CDI)
Clostridium difficileinfection (CDI) is a serious illness resulting from
infection of the inner lining of the colon byC. difficilebacteria, 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. difficilehas surpassed
methicillin-resistantStaphylococcus aureus(MRSA) as the leading cause of
healthcare-acquired infections in community hospitals. Patients typically
develop CDAD from the use of broad-spectrum antibiotics that disrupt normal
gastrointestinal (gut) flora, possibly allowingC. difficilebacteria to
About DIFICID® (fidaxomicin) Tablets
DIFICID is the first macrolide antibacterial drug indicated forClostridium
difficile-associated diarrhea (CDAD) to be approved in over 25 years in the
U.S. It is indicated for the treatment of CDAD in adults 18 years of age or
older. DIFICID is administered in 200 milligram tablets given orally twice
Important Safety Information for DIFICID
DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin or
to any of the excipients in the formulation. DIFICID should not be used for
systemic infections. Only use DIFICID for infection proven or strongly
suspected to be caused byC. difficile. Prescribing DIFICID in the absence of
a proven or strongly suspectedC. difficile infection is unlikely to provide
benefit to the patient and increases the risk of the development of drug
resistant bacteria. The most common adverse reactions are nausea (11%),
vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia
(2%) and neutropenia (2%).
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR)is a global biopharmaceutical
company focused on developing and commercializing innovative hospital
specialty products that have a positive impact on society. Optimer developed
DIFICID® (fidaxomicin) tablets, anFDA-approved macrolide antibacterial drug
for the treatment ofClostridium difficile-associated diarrhea (CDAD) in
adults 18 years of age and older and is commercializing DIFICID in the U.S.
and Canada. Optimer also received marketing authorization for fidaxomicin
tablets in theEuropean Unionwhere its partner,Astellas Pharma Europe, is
commercializing fidaxomicin under the trade name DIFICLIR™. The Company is
exploring marketing authorization in other parts of the world whereC.
difficilehas emerged as a serious health problem, includingAsia. Additional
information can be found athttp://www.optimerpharma.com.
Forward Looking Statements
Statements included in this press release that are not a description of
historical facts are forward-looking statements, including without limitation
statements related to, the potential benefits of DIFICID in treating certain
patients and the risk, impact and burden of CDAD. Words such as "believes,"
"would," "anticipates," "plans," "expects," "may," "intend," "will" and
similar expressions are intended to identify forward-looking statements. The
inclusion of forward-looking statements should not be regarded as a
representation by Optimer that any of its plans will be achieved. These
forward-looking statements are based on management's expectations on the date
of this release. Actual results may differ materially from those set forth in
this release due to the risks and uncertainties inherent in Optimer's business
including, without limitation, risks relating to: the possibility of
alternative means of preventing or treating CDAD, whether Optimer will conduct
additional clinical trials with respect to DIFICID or whether any such trials
will be successful, and other risks detailed in Optimer's filings with
theSecurities and Exchange Commission. Forward-looking statements speak only
as of the date of this release, and Optimer undertakes no obligation to update
or revise these statements, except as may be required by law.
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
SOURCE Optimer Pharmaceuticals, Inc.
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