New Data Show Continued Efficacy of Rocephin Against Community-Acquired Pneumonia-Causing Bacteria

NUTLEY, N.J. -- New research released today by the University of Florida College of Pharmacy suggest that treating community-acquired pneumonia (CAP) with Rocephin (ceftriaxone), the third-generation cephalosporin antibiotic, may delay the emergence of treatment-resistant S. pneumoniae bacteria. The data showed that S. pneumoniae, the most common pathogen in respiratory tract infections like CAP, is less resistant to Rocephin compared to cefotaxime, another third-generation cephalosporin antibiotic, or penicillin. These data, part of the University of Florida's ongoing Antimicrobial Resistance Management (ARM) Program, were presented at the American Thoracic Society 99th International Conference.

S. pneumoniae is the single leading cause of CAP and other respiratory infections, with significant impact on the public - the approximately 1.7 million hospitalizations for CAP are estimated to cost $23 billion annually in the U.S. [1-2] Respiratory isolates of S. pneumoniae are growing increasingly resistant to various antibiotics, including cefotaxime. In fact, the increased resistance of S. pneumoniae to cefotaxime previously observed in other research [3] prompted this continued analysis of cefotaxime data in the ARM program.

In this study, S. pneumoniae bacteria were the least resistant overall to Rocephin compared to cefotaxime and penicillin (18.8 percent vs. 28.1 percent and 38.4 percent). Across the years examined (1994-2001), the resistance rates across U.S. regions were also lower for Rocephin compared to both of the other antibiotics studied.

"This analysis from the ARM program reinforces earlier data showing increased S. pneumoniae resistance to cefotaxime," said John G. Gums of the University of Florida in Gainesville, Fla. "This is certainly an emerging issue for clinicians to monitor closely, and consider when treating patients for CAP."

The Antimicrobial Resistance Management (ARM) Program is an ongoing study to document trends in antimicrobial susceptibility patterns in inpatient and outpatient isolates and to identify relationships between antibiotic use and resistance rates. As of April 22, 2003, 251 institutions in the U.S. are enrolled in the program. Resistance rates in the hospitals are examined nationally and across six geographic regions: North Central, Northeast, Northwest, South Central, Southeast and Southwest. Each hospital provides a minimum of three years of antibiogram or sensitivity report data on 44 individual antibiotics and 16 different organisms. A web-based analysis tool allows comparisons between antibiotic use and resistance rates across several parameters. In this analysis, University of Florida researchers analyzed ARM data from 1994 to 2001.

Rocephin is indicated for the treatment of the following infections when caused by susceptible organisms: lower respiratory tract infections, skin and skin structure infections, urinary tract infections, uncomplicated gonorrhea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra-abdominal infections, meningitis, surgical prophylaxis and acute bacterial otitis media.

The Food and Drug Administration (FDA) first approved Rocephin in January 1985. Physicians have treated more than 100 million patients with Rocephin worldwide. Rocephin is generally well tolerated. Adverse clinical effects in adults occur at levels similar to those of other cephalosporins: diarrhea (2.7 percent), rash (1.7 percent) and local reactions (<1 percent). In pediatric patients treated for bacterial otitis media, except for injection-site reactions (1.6 percent), adverse clinical effects occurred at levels similar to other antimicrobials: diarrhea (14.1 percent), diaper rash (5.2 percent), rash (4.9 percent) and vomiting (1.4 percent). The incidence of warmth, tightness or induration was 17 percent (3/17) after IM administration of 350 mg/mL and 5 percent (1/20) after IM administration of 250 mg/mL. Rocephin is contraindicated in patients with a known allergy to cephalosporins and should be used cautiously in penicillin-sensitive patients.

Hoffmann-La Roche Inc. is the U.S. prescription drug unit of the Roche Group, a leading research-based healthcare enterprise that ranks among the world's leaders in pharmaceuticals and diagnostics. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

References:

[1] Sue DY. Community-acquired pneumonia in adults. West J Med. 1994;161:383-389.

[2] Bartlett JG, Mundy M. Community-acquired pneumonia. N Engl J Med. 1995;333:1618-1624.

[3] Gums JG. Streptococcus pneumoniae susceptibility from 1995-2000: Results of the Antimicrobial Resistance Management (ARM) program [abstract]. Am J Respir Crit Care Med. 2002;165(8). Abstract J70.

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