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Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis

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Summary

In an evaluator-blind, paralled-group, multicenter study, the efficacy and tolerability of ceftibuten 400 mg capsules once daily were compared with clarithromycin 500 mg twice daily for 7–14 days in the treatment of 309 patients with acute exacerbation of chronic bronchitis (AECB). Clinical (n=262) and microbiological (n=71) assessments were conducted before treatment, during days 4–6 of treatment, and at 0–6 and 7–21 days after treatment. Clinical efficacy success rates (cure/improvement) at the end of treatment (0–6 days) were 91.0% for ceftibuten and 93.0% for clarithromycin. In the intent-to-treat population, the overall clinical assessment showed a success rate of 77.6% (121/156) in the ceftibuten group and 78.4% (120/153) in the clarithromycin group (95% confidence interval, −10.8 to +9.0%). One patient in each of the ceftibuten and clarithromycin groups had a microbiological relapse and became a treatment failure. The overall success rate was 84.3% for ceftibuten and 86.7% for clarithromycin (C.I. −11.7%, +6.9%). Overall eradication of the target pathogens (Haemophilus influenzae, Moraxella catarrhalis, andStreptococcus pneumoniae) was 84.8% for ceftibuten and 89.5% for clarithromycin. Eradication rates for ceftibuten at 0–6 days post treatment were 95.2% (H. influenzae), 87.5% (M. catarrhalis), and 100% (S. pneumoniae), compared with 85.7%, 100% and 100%, respectively, for clarithromycin. Significantly fewer patients in the ceftibuten group experienced treatmentrelated adverse events than in the clarithromycin group (5.3 vs 21.9%; p<0.001). This difference was due to a large number of patients in the clarithromycin group reporting taste perversion (12.6%) or gastrointestinal adverse events (9.9%). Given its tolerability and efficacy profiles, and the advantage of once-daily administration, ceftibuten provides a rational alternative for the treatment of AECB.

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  1. Central California Research Institute, 4747 N 1st St., 93726, Fresno, CA

    W. Ziering M.D.

  2. 1200 La Cruz St., El Paso, TX, USA

    P. McElvaine M.D.

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  2. P. McElvaine M.D.
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Ziering, W., McElvaine, P. Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis. Infection 26, 68–75 (1998). https://doi.org/10.1007/BF02768764

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