COMPARATIVE UNITED-STATES AND EUROPEAN TRIALS OF LORACARBEF IN THE TREATMENT OF ACUTE OTITIS-MEDIA

Acute otitis media with effusion is one of the most common infectious diseases of childhood. Two multicenter randomized controlled clinical trials were conducted to assess the relative safety and efficacy of loracarbef and either amoxicillin/clavulanate or amoxicillin in the treatment of acute otitis media. Patients were evaluated clinically and bacteriologically at a pretherapy visit (within 48 hours of study drug administration), a posttherapy visit (within 72 hours after completion of therapy), and a late posttherapy visit (10 to 16 days after completion of therapy). In both studies, etiologic agents were assessed by tympanocentesis. In both studies patients had to have a pathogen susceptible to both study drugs to be continued in the study and declared evaluable. The first study, conducted at 24 United States centers, compared loracarbef 30 mg/kg/day in two divided doses and amoxicillin/clavulanate 40 mg/kg/day in three divided doses each for 10 days. At the posttherapy visit 124 (87.3%) of 142 evaluable loracarbef-treated patients and 130 (91.5%) of 142 evaluable amoxicillin/clavulanate-treated patients had favorable (cure or improvement) clinical outcomes (P = 0.247). Loracarbef-treated patients were significantly less likely to experience adverse events, notably diarrhea, than amoxicillin/clavulanate-treated patients (P < 0.001). The second study, conducted at 12 European sites, compared loracarbef 30 mg/kg/day in two divided doses and amoxicillin 40 mg/kg/day in three divided doses each for 7 days. At the posttherapy visit 120 (81.1%) of 148 evaluable loracarbef-treated patients and 125 (87.4%) of 143 amoxicillin-treated patients had favorable clinical outcomes (P = 0.139). Loracarbef and amoxicillin displayed comparable safety, although vomiting appeared more frequently among patients receiving amoxicillin (P = 0.011). Loracarbef is comparable to amoxicillin/clavulanate or amoxicillin in the treatment of acute otitis caused by susceptible organisms and provides potential advantages of an improved safety profile and twice daily dosing.