Loracarbef versus clarithromycin in children with acute otitis media with effusion

Two multicenter, randomized, single-masked, parallel-group studies compared loracarbef and clarithromycin with regard to efficacy, tolerability, and p atient acceptance. Three hundred thirty-four children aged 6 months to 3 ye ars with acute otitis media with effusion received loracarbef (15 mg/kg) or clarithromycin (7.5 mg/kg) orally twice daily for 10 days. Patients were a ssessed for the presence of the diagnostic signs and symptoms of otitis med ia with effusion by physical examination and pneumatic otoscopy at 48 hours pretreatment, 3 to 5 days after initiation of treatment, 0 to 3 days after the final dose (posttreatment), and 14 to 21 days later (termination). Sym ptoms were assigned numeric values. Symptomatic response was assessed at th e posttherapy and termination visits. Tolerability was determined by assess ing adverse events, and a patient acceptance survey was completed by each p atient's caregiver. The combined results of these 2 studies showed that the efficacy and tolerability of loracarbef were comparable to those of clarit hromycin. Adverse events were reported by 46.4% of loracarbef patients and 41.0% of clarithromycin patients, with no statistically significant differe nce between groups. In the intent-to-treat analysis, 57.9% of loracarbef pa tients were cured at the termination of the study, compared with 55.7% of c larithromycin patients. Improvement was seen in 4.1% of loracarbef patients and 2.7% of clarithromycin patients. Results of the patient acceptance sur vey showed a clear preference for loracarbef over clarithromycin. Difficult ies with administration of treatment were reported by 36.3% of clarithromyc in caregivers, compared with 7.8% of loracarbef caregivers (P < 0.001). A d esire to stop treatment was reported by 23.8% of clarithromycin caregivers, compared with 7.8% of loracarbef caregivers (P < 0.001). Taste and texture issues were most frequently cited as reasons for nonacceptance.