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Title: ICAAC: Gatifloxacin Has Higher Cure Rate For Bronchitis Than Cefuroxime Axetil
URL: http://www.pslgroup.com/dg/133CAA.htm
Doctor's Guide
September 29, 1999


SAN FRANCISCO, CA. -- September 29, 1999 -- The results of a multinational, multi-center, Phase III study comparing the efficacy and safety of gatifloxacin to cefuroxime axetil showed gatifloxacin to be significantly more efficacious in treating acute exacerbation of chronic bronchitis (AECB).

The study findings were presented this week at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in San Francisco.

"Significantly, gatifloxacin achieved a 100 percent cure rate for patients diagnosed with Streptococcus pneumoniae or Haemophilus influenzae, in contrast with 44 percent and 69 percent, respectively for cefuroxime axetil, a cephalosporin comparator," commented lead researcher Carl A. DeAbate, MD, CEO, Medical Research Centers, New Orleans, Louisiana. "Our study indicates that gatifloxacin demonstrates impressive and consistent coverage of respiratory pathogens, particularly those most prevalent in AECB."

The randomized, double blind study compared 211 adult outpatients diagnosed with acute exacerbation of chronic bronchitis who received 400 mg qd of gatifloxacin or 250 mg bid of cefuroxime axetil for 7-10 days. The study was designed in accordance with current guidelines for the treatment of AECB by the Infectious Disease Society of America (IDSA) and the U.S. Food and Drug Administration (FDA).

The results demonstrated a better clinical cure rate with gatifloxacin (89 percent) compared with cefuroxime axetil (77 percent). Microbiologic eradication was 100 percent for gatifloxacin compared with 38 percent for cefuroxime axetil.

Chronic bronchitis is a long-term inflammation in the bronchi of the lungs (the two main branches leading from the trachea to the lungs), characterized by symptoms of a cough with excessive phlegm production for more than three months of the year and more than two years in a row. Chronic bronchitis affects up to 50 million Americans each year. Risk factors include smoking, recurrent respiratory infections, chronic obstructive pulmonary disease (COPD) and allergies. It is a frequent cause of hospital admissions (intensive care units) and the use of oxygen equipment.

Acute bacterial exacerbation of chronic bronchitis occurs when patients with chronic bronchitis have episodes of bacterial infection in the lungs, making symptoms of bronchitis much worse.

"The rise in antibiotic-resistant strains of respiratory tract infection pathogens has produced a pressing need for new antibiotic treatments. The results of gatifloxacin in this AECB trial prove it to be a useful addition to the practitioner's armamentarium," observed Dr. DeAbate.

Gatifloxacin is the first in a new chemical class of antibiotics, an advanced-generation broad-spectrum 8-methoxy fluoroquinolone. Its long half-life allows for once-daily dosing. It is specifically designed to treat respiratory tract and other common infections such as AECB, examined in the Phase III study.

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