New Head-To-Head Study Presented at 16th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID)
KENILWORTH, N.J., April 7 /PRNewswire-FirstCall/ -- AVELOX(R)
(moxifloxacin HCl) monotherapy at 400 mg once daily is as effective as the
high-dose combination of levofloxacin (500 mg twice daily) plus ceftriaxone
(2 g once daily) in treating patients with severe community-acquired
pneumonia (CAP) requiring hospitalization, according to results of a new
clinical study presented at the 16th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) in Nice, France.
Known as the MOTIV (Moxifloxacin Treatment Intravenous) study, the
head- to-head comparison of once-daily AVELOX monotherapy to a combination
of high- dose levofloxacin plus high-dose ceftriaxone showed no significant
difference in clinical cure rates (4-14 days after the last dose), the
primary efficacy endpoint for the two per protocol treatment groups (86.9
percent vs. 89.9 percent, respectively), including CAP patients with the
most severe pneumonia. The per protocol population consisted of 569
patients. A total of 748 patients were enrolled in the study, of which 738
patients were randomized. Both treatments were well tolerated in the study,
with similar adverse event profiles.
"The results of the MOTIV study are important because
community-acquired pneumonia is a particular concern for people with
chronic illnesses or impaired immune systems, and is a common cause of
hospitalization worldwide," said Antoni Torres, M.D., professor of
pulmonology at the University of Barcelona in Spain. "CAP can critically
affect older patients who may be struggling with existing conditions such
as heart disease and diabetes," he added. "These results provide additional
evidence that AVELOX is a safe and effective treatment for patients with
CAP."
CAP affects approximately 5.6 million adults in the United States each
year, with elderly patients (age 65 and above) 60 percent more likely than
the general population to develop the infection.(1,2)
AVELOX, a broad-spectrum fluoroquinolone antibiotic, has been shown to
be safe and effective as monotherapy in treating patients with CAP and is
approved for this indication. (See About AVELOX section below for more
information.)
Study Design
The MOTIV study was a prospective, randomized, multicenter,
multinational, double-blind, double-dummy comparative study conducted
outside the United States designed to determine the efficacy and safety of
AVELOX versus a combination of high-dose levofloxacin and high-dose
ceftriaxone in treating severe CAP requiring hospitalization and parenteral
treatment (treatment by injection). The high-dose of levofloxacin as well
as the combination therapy used in the study are not approved in the United
States.
Patients in the study were randomized to receive either: AVELOX
I.V./oral 400 mg once daily for seven to 14 days; or the combination of
ceftriaxone I.V. 2 g once daily plus levofloxacin I.V. 500 mg twice daily,
followed by levofloxacin oral 500 mg twice daily, for seven to 14 days. The
dose of levofloxacin could be adjusted according to the patient's renal
function. Patients in the study were stratified by the Pneumonia Severity
Index, with 59.1 percent of the 569 patients in the per protocol population
classified as having severe pneumonia (PSI Classes IV-V).
About Community-Acquired Pneumonia (CAP)
Community-acquired pneumonia affects 5.6 million adults in the United
States annually, resulting in nearly two million cases of
hospitalization.(3,4) It is the fifth leading cause of death among people
older than 65 years, and a larger percentage of these patients have
frequent co-morbidities and require hospitalization and longer hospital and
intensive care unit (ICU) stays.(5,6) The cost of treating CAP patients is
estimated at $10 billion per year, with 92 percent of those costs spent on
hospitalized care.(7) Community-acquired pneumonia is a particular concern
for seniors and people with chronic illnesses or impaired immune systems,
although it also affects young and healthy people.
About AVELOX
AVELOX, available in tablet and I.V. formulations, was developed by
Bayer Pharmaceuticals Corporation and is marketed in the United States by
Schering- Plough. AVELOX offers patients a once-daily dosing regimen that
does not require dosage adjustment when transitioning from I.V. to oral
therapy. AVELOX patients suffering from renal impairment do not need to
have their dosage adjusted.
AVELOX is indicated for the treatment of adults (18 years of age and
older) with infections cause by susceptible strains of the following
designated microorganisms: Acute Bacterial Sinusitis (ABS) caused by
Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis;
Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by
Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus
parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible
Staphylococcus aureus or Moraxella catarrhalis; Community Acquired
Pneumonia (CAP) caused by Streptococcus pneumoniae (including multi-drug
resistant strains*), Haemophilus influenzae, Moraxella catarrhalis,
methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae,
Mycoplasma pneumoniae or Chlamydia pneumoniae; Uncomplicated Skin and Skin
Structure Infections (uSSSI) caused by methicillin-susceptible
Staphylococcus aureus or Streptococcus pyogenes; Complicated Skin and Skin
Structure Infections (cSSSI) caused by methicillin-susceptible
Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or
Enterobacter cloacae; and Complicated Intra-Abdominal Infections (cIAI)
including polymicrobial infections such as abscesses caused by Escherichia
coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus
constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium
perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.
* MDRSP, Multi-drug resistant Streptococcus pneumoniae, includes
isolates previously known as PRSP (Penicillin-resistant Streptococcus
pneumoniae), and are strains resistant to two or more of the following
antibiotic classes: penicillin (MIC greater than or equal to 2 mcg/mL),
second generation cephalosporins (e.g., cefuroxime), macrolides,
tetracyclines and trimethoprim/sulfamethoxazole.
Safety Information about AVELOX
AVELOX is generally well tolerated. The most common side effects caused
by AVELOX, which are usually mild, include dizziness, nausea and diarrhea.
Patients should be careful about driving or operating machinery until they
are sure that AVELOX is not causing dizziness. Patients should inform a
health care professional of other side effects.
Patients who have ever had an allergic reaction to AVELOX or any of the
other group of antibiotics known as "quinolones" should avoid taking
AVELOX.
Patients who have been diagnosed with an abnormal heartbeat such as an
arrhythmia or are using certain medications used to treat an abnormal
heartbeat should avoid taking AVELOX.
AVELOX is not for use during pregnancy or nursing, as the effects on
the unborn child or nursing infant are unknown. AVELOX is not for children
under the age of 18 years.
Convulsions have been reported in patients receiving quinolone
antibiotics. Patients should be sure to let their physician know if they
have a history of convulsions.
Many antacids and multivitamins may interfere with the absorption of
AVELOX and may prevent it from working properly. Patients should take
AVELOX either 4 hours before or 8 hours after taking these products.
Please see full prescribing information for AVELOX available at
http://www.AVELOXUSA.com.
About Schering-Plough
Schering-Plough is a global science-based health care company with
leading prescription, consumer and animal health products. Through internal
research and collaborations with partners, Schering-Plough discovers,
develops, manufactures and markets advanced drug therapies to meet
important medical needs. Schering-Plough's vision is to earn the trust of
the physicians, patients and customers served by its more than 32,000
people around the world. The company is based in Kenilworth, N.J., and its
Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains certain
"forward-looking statements" within the meaning of the Securities
Litigation Reform Act of 1995, including statements related to the
potential market for AVELOX. Forward-looking statements relate to
expectations or forecasts of future events. Schering-Plough does not assume
the obligation to update any forward-looking statement. Many factors could
cause actual results to differ materially from Schering-Plough's
forward-looking statements, including market forces, economic factors,
product availability, patent and other intellectual property protection,
current and future branded, generic or over-the-counter competition and the
regulatory process, and any developments following regulatory approval,
among other uncertainties. For further details about these and other
factors that may impact the forward-looking statements, see
Schering-Plough's Securities and Exchange Commission filings, including
Item 1A. Risk Factors in the Company's 2005 10-K.
AVELOX is a registered trademark of Bayer AG and is used under license
by Schering-Plough.
Levofloxacin is marketed as LEVAQUIN in the United States. LEVAQUIN is
a registered trademark of Ortho-McNeil Pharmaceutical.
Ceftriaxone is marketed as ROCEPHIN in the United States. ROCEPHIN is a
registered trademark of Roche Laboratories Inc.
References:
1. Centers for Disease Control and Prevention. Premature deaths, monthly
mortality and monthly physician contacts: United States. MMWR
1997;46:556.
2. Stanton M. Research in Action, Issues 7: Improving Treatment Decisions
for Patients with Community-Acquired Pneumonia. Available at
http://www.ahrq.gov/clinic/pneumonia/pneumonria.htm. Accessed on
August 30, 2005.
3. Centers for Disease Control and Prevention. Premature deaths, monthly
mortality and monthly physician contacts: United States. MMWR
1997;46:556.
4. Niederman MS, McCombs JS, Unger AN, et al. The cost of treating
community-acquired pneumonia.
Clin Ther 1998;20:820-837.
5. Houck P, et al. Timing of Antibiotic Administration and Outcomes for
Medicare Patients Hospitalized with Community-Acquired Pneumonia. Arch
Intern Med. 2004;164:637-644.
6. Niederman M. Community-acquired Pneumonia: Management Controversies,
Part I; Practical Recommendations from the Latest Guidelines. Am J
Respir Crit Care Med. 2001(5).
7. Lave JR, Lin CJ, Fine MJ, et al. The cost of treating patients with
community-acquired pneumonia.
Semin Respir Crit Care Med 1999;20(3):189-97.
SOURCE Schering-Plough
 back to top
Related links:
http://www.schering-plough.com
http://www.AVELOXUSA.com
http://www.prnewswire.com/comp/777050.html /
CONTACT:
Media: Robert Consalvo, +1-908-298-7409, or
Robin Nearman, +1-908-298-5153, or Investors: Alex Kelly,
+1-908-298-7436
|
