Clinical Comparison of Cefuroxime Axetil with Cefixime in the Treatment of Acute Bronchitis.

Acute bronchitis is the ninth most common outpatient illness seen by physicians in the United States. Oral antibiotic treatment is usually directed empirically against the most common bacterial pathogens associated with acute bronchitis, such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Although cefuroxime axetil and cefixime are both approved in the United States for treatment of acute bronchitis, currently they have not undergone direct clinical comparison for this indication. This randomized, investigator-blind, multicenter study was designed to compare the efficacy and safety of 250 mg cefuroxime axetil administered twice daily with that of 400 mg cefixime administered once daily in the treatment of acute bronchitis. Outpatients had to be greater-than-or-equal12 years of age and have signs and symptoms of acute bronchitis to be eligible for this study. Patients were randomly assigned to receive 10 days of oral treatment with either 250 mg cefuroxime axetil taken twice daily or 400 mg cefixime taken once daily. Patients were assessed for both clinical and bacteriologic responses once during treatment (3--5 days) and twice after treatment (1--3 days and 14 days). Bacteriologic assessments were based on sputum specimen cultures obtained pretreatment and posttreatment when possible. Of 465 patients with acute bronchitis who were enrolled in the study, 227 received cefuroxime axetil and 238 received cefixime. Organisms were isolated from the pretreatment sputum specimens in 172 of the 465 (37%) patients, with the primary pathogens being Haemophilus influenzae, Streptococcus pneumoniae, Morazella catarrhalis, and Staphylococcus aureus (30%, 14%, 14%, and 14% of isolates, respectively). A satisfactory clinical outcome (cure or improvement) was achieved in 88% (130 of 148) and 91% (152 of 167) of the clinically evaluable patients who had received cefuroxime axetil or cefixime, respectively (p = 0.36). Regarding the eradication of bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 89% (47 of 53) and 91% (41 of 45) of bacteriologically evaluated patients who had received cefuroxime axetil or cefixime, respectively (p = 0.75). Treatment with cefixime was associated with a significantly higher incidence of drug-related gastrointestinal adverse events than was treatment with cefuroxime axetil (18% versus 10%, respectively; p = 0.01). This difference primarily reflects a higher incidence of drug-related diarrhea (15% versus 5%, p = 0.001). These results indicated the cefuroxime axetil taken twice daily is as effective as cefixime taken once daily in the treatment of acute bronchitis and that cefuroxime axetil produces fewer gastrointestinal adverse events, particularly diarrhea.