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Short Course of Levofloxacin Effective for Complicated and Uncomplicated Acute Bacterial Exacerbation of Chronic Bronchitis: Presented at ATS

By Charlene Laino

ORLANDO, FL -- May 27, 2004 -- A short course of levofloxacin offers advantages over more commonly used treatments for the treatment of patients with both complicated and uncomplicated acute bacterial exacerbation of chronic bronchitis (ABECB), suggest findings from a phase 3b study.

Neringa Zadeikis, MD, MBA, Associate Director, Infectious Disease Research, Clinical Affairs, Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey, presented the study here on May 26th at the 100th International Conference of the American Thoracic Society.

"Previous studies have lumped all acute bacterial exacerbation of chronic bronchitis patients together, but there are really two groups -- [those with] complicated and uncomplicated [disease] -- as defined by the Canadian acute bacterial exacerbation of chronic bronchitis treatment guidelines," Dr. Zadeikis said.

The current study stratified 763 patients with ABECB. Uncomplicated disease was defined as pre-exacerbation forced expiratory volume in 1 second of 50% or greater of predicted, fewer than 4 exacerbations per year, and no comorbidities, she said. These patients were randomized to 750 mg of levofloxacin a day for 3 days or 500 mg of azithromycin on day 1 followed by 250 mg/day on days 2-5.

Patients with complicated disease were randomized to 750 mg/day of levofloxacin for 5 days or 875 mg of amoxicillin and 125 mg of clavulanate twice a day for 10 days.

Among clinically evaluable patients with uncomplicated disease, 93.0% of those taking levofloxacin were cured or improved, compared with 90.1% of those on azithromycin (95% CI, -9.6 to 3.8). The microbiologic eradication rates were 93.8% in the levofloxacin arm versus 82.8% in the azithromycin arm (95% CI, -21.2 to -0.8).

Among patients with complicated disease, the clinical success rates were 79.2% in the levofloxacin group and 81.7% in the amoxicillin/clavulanate arm (95% CI, -7.8 to 12.9). The microbiologic eradication rates were 81.4% and 79.8%, respectively (95% CO, -13.9 to 10.7)

Levofloxacin 750 mg for 3 days was superior to azithromycin in patients with uncomplicated disease and levofloxacin 750 mg for 5 days was equivalent to 10 days of amoxicillin/clavulanate for complicated disease, but with faster resolution of symptoms, Dr. Zadeikis said.

"Previous guidelines don't address the use of levofloxacin for uncomplicated [disease], instead naming macrolides as the drug of choice," she said. "This study demonstrates that levofloxacin is clinically and microbiologically superior to azithromycin, so perhaps levofloxacin should take its place in treatment guidelines for uncomplicated acute bacterial exacerbations of chronic bronchitis."


[Presentation title: "The safety and efficacy of short-course (3-5 day), 750 mg levofloxacin (LVX) for acute bacterial exacerbation of chronic bronchitis (ABECB)." Abstract D22 Poster #516]

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