A prospective, multicentre, randomized, open-label, parallel group study compared the efficacy, safety and tolerability of
cefuroxime 750 mg iv administered either twice daily (bd) or three times daily (
tds) for 48-72 h, followed by oral
cefuroxime axetil 500 mg bd for 5-7 days in a sequential
therapy regimen for the treatment of acute exacerbations of
chronic bronchitis. A total of 628 adult patients entered the study; 323 in the
cefuroxime tds group and 305 in the
cefuroxime bd group. For clinically evaluable patients, the post-treatment clinical response rate was 86% and 88% in the
cefuroxime tds and bd groups, respectively. Cure was maintained at follow-up (14-28 days
after treatment completion) in 85% of the
cefuroxime tds group and 84% of patients in the
cefuroxime bd group. A total of 189 pathogens was isolated, the most common being Haemophilus influenzae (17%), other Haemophilus spp. (15%), Streptococcus pneumoniae (15%) and Enterobacteriaceae (23%). At the post-treatment assessment, 66% and 70% of pathogens were cleared in the
cefuroxime tds and bd groups, respectively. Both treatment regimens were well tolerated. The incidence of
drug-related adverse events was 7% in the
cefuroxime tds group and 6% in the
cefuroxime bd group; the most common side-effects were gastrointestinal. Qualitative and quantitative markers were used to determine the optimal time to switch from iv to oral
therapy and, of these, peak expiratory flow rate was shown to be the most useful in the present study. In conclusion, the findings of this study support the use of a bd dosing schedule of
cefuroxime in a sequential
therapy regimen with oral
cefuroxime axetil, demonstrating it to be clinically equivalent to the standard
tds dosage currently used, as well as being simpler and more convenient to administer at a lower cost.