Abstract
OBJECTIVE: To compare the efficacy and tolerability of levofloxacin (the l-isomer of ofloxacin) 500 mg given orally once daily for 5-7 days with those of cefuroxime axetil 250 mg twice daily for 10 days. METHODS: Outpatients with a confirmed diagnosis of an acute bacterial exacerbation of chronic bronchitis (ABECB) were enrolled in this randomized, multicenter, open-label trial. Patients were evaluated before, during, and following therapy (5-7 days after termination of therapy). RESULTS: 248 patients received levofloxacin for a mean of 7 days and 244 received cefuroxime axetil for a mean of 10 days. Clinical response was rated a success (patient cured or improved) for 94.6% (210/222) of clinically evaluable levofloxacin-treated patients and 92.6% (212/229) of clinically evaluable cefuroxime axetil-treated patients. Microbiologic eradication rates by pathogen for microbiologically evaluable subjects were 97.4% for levofloxacin and 94.6% for cefuroxime axetil. Resistance to levofloxacin was found in 2% of isolates; 9% of isolates were resistant to cefuroxime. Both treatments were generally well tolerated with the most common adverse events in both groups affecting the gastrointestinal tract. CONCLUSIONS: When given orally, a once daily 500-mg dose of levofloxacin for 5-7 days was as effective and well tolerated as cefuroxime axetil (250 mg bid) given for 10 days to patients with ABECB.
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