Sequential therapy with cefuroxime followed by cefuroxime axetil in acute exacerbations of chronic bronchitis

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.