Five days of cefprozil versus 10 days of clarithromycin in the treatment of an acute exacerbation of chronic bronchitis.

BACKGROUND

Shorter than traditional 7- to 14-day treatment regimens have demonstrated efficacy in treatment of an acute exacerbation of chronic bronchitis (AECB).

OBJECTIVE

Perform a clinical efficacy study comparing 5 days of cefprozil therapy to 10 days of clarithromycin in treating an AECB.

METHODS

A multicenter, randomized, double-blind study comparing efficacy and safety of cefprozil, 500 mg twice daily, for 5 days with clarithromycin, 500 mg twice daily, for 10 days in treatment of 295 subjects with AECB. Concomitantly, among all treated subjects, 39% (115 of 295) had a history of chronic obstructive pulmonary disease/emphysema; 21% (62 of 295) had a history of asthma/reactive airway disease; and 31% (90 of 295) had environmental allergies.

RESULTS

There were no statistically significant differences among clinically evaluable subjects' cure rates; 82% (109 of 133) treated with cefprozil versus 85% (105 of 123) treated with clarithromycin were cured at test-of-cure visit (95% confidence interval, -12.0 to 5.1%). Clinical cure rates at end of study were 80% and 81%, respectively (95% confidence interval, -10.8 to 7.9%). Before treatment, 99% (85 of 86) of Gram-positive organisms isolated were susceptible to cefprozil and 78% (67 of 86) were susceptible to clarithromycin. A total of 84% (96 of 114) of Gram-negative organisms were susceptible to cefprozil and 63% (72 of 114) were susceptible to clarithromycin. Of clinically evaluable Streptococcus pneumoniae-infected subjects, 100% (11 of 11) of cefprozil subjects and 93% (14 of 15) of clarithromycin subjects experienced clinical cure. The most frequently reported adverse effects were nausea, 5% (7 of 150), and diarrhea, 9% (14 of 150), for cefprozil. For clarithromycin, the adverse effects were nausea, 8% (11 of 145); diarrhea, 12% (18 of 145); taste perversion, 8% (11 of 145); and dry mouth, 5% (7 of 145).

CONCLUSIONS

Five days of cefprozil is as effective as 10 days of clarithromycin for treatment of an AECB.