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Levofloxacin a Treatment of Choice for Resistant Acute Bacterial Exacerbation of Chronic Bronchitis: Presented at ATS

By Charlene Laino

ORLANDO, FL -- May 26, 2004 --- Levofloxacin should be considered a treatment of choice for patients with acute bacterial exacerbation of chronic bronchitis (ABECB), suggests a new analysis of data from a phase 3b study.

Neringa Zadeikis, MD, MBA, associate director, infectious disease research, clinical affairs, Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey, spoke about the results of the study on May 23rd at the 100th International Conference of the American Thoracic Society.

When ABECB is suspected, patients are usually at first treated empirically with an antibiotic to cover the most common pathogens, such as Streptococcus pneumoniae, Dr. Zadeikis said. However, the growing incidence of resistance to many commonly used anti-infectives, including penicillin and macrolides, is complicating the decision of which agent to prescribe, Dr. Zadeikis said.

The new study sought to determine if levofloxacin might be a better option than some of the more commonly prescribed agents.

The researchers studied 763 patients enrolled in a phase 3b randomized trial that compared various antimicrobial regimens. Based on their forced expiratory volume in 1 second (above or below 50% predicted), the presence or absence of comorbidity, and frequency of exacerbations (fewer than 4 per year or 4 per year or more); 394 patients were classified as having uncomplicated ABECB and 369 patients were classified with complicated ABECB.

Patients with uncomplicated disease received 750 mg of levofloxacin daily for 3 days, or 500 mg of azithromycin on day 1 followed by 250 mg of azithromycin daily on day 2 to day 5. Patients with complicated disease received 750 mg of levofloxacin a day for 5 days or 875 mg of amoxicillin and 125 mg of clavulanate twice a day for 10 days.

Of the 54 microbiologically evaluable patients with S. pneumoniae isolates, penicillin-resistance was found in 35% of patients with complicated disease compared with 4% of patients with uncomplicated disease, the study showed. Azithromycin resistance was found in 45% of S. pneumoniae isolates in patients with complicated disease and 35% of those with uncomplicated disease.

Levofloxacin-resistant S. pneumoniae was isolated from none of 23 patients with uncomplicated disease and from 2 of 31 patients with complicated disease. All 17 of the patients treated with levofloxacin were clinically successful in eradicating infection, including the 2 patients with a levofloxacin-resistant strain, Dr. Zadeikis reported.

"Overall, 40% and 20% of Streptococcus pneumoniae isolated from acute bacterial exacerbation of chronic bronchitis patients were resistant to azithromycin and penicillin, respectively," Dr. Zadeikis said. Also, over 80% of isolates that were resistant to azithromycin were multidrug resistant, she noted.

"Whether used for 3 or 5 days, levofloxacin resistance was very low, while penicillin and azithromycin resistance was very common, more so if patients had complicated acute bacterial exacerbation of chronic bronchitis," Dr. Zadeikis said.

"Levofloxacin should be considered as a treatment for patients with acute bacterial exacerbation of chronic bronchitis," she concluded.


[Presentation title: "Antimicrobial-Resistant Streptococcus pneumoniae Isolated From Patients With Acute Bacterial Exacerbation of Chronic Bronchitis." Abstract #A47 Poster #E28]

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