A COMPARATIVE-STUDY OF THE EFFICACY AND SAFETY OF LORATADINE SYRUP AND TERFENADINE SUSPENSION IN THE TREATMENT OF 3-YEAR-OLD TO 6-YEAR-OLD CHILDREN WITH SEASONAL ALLERGIC RHINITIS

The efficacy and safety of loratadine and terfenadine in the treatment of 3- to 6-year-old children with seasonal allergic rhinitis were com pared in a third-party-blind, randomized, parallel-group study. A tota l of 96 children were included in the efficacy analysis: 49 children r eceived 5 or 10 mg of loratadine once daily, and 47 received 15 mg of terfenadine twice daily, for 14 days. The mean total score for both na sal and nonnasal symptoms was decreased significantly from baseline at days 3, 7, and 14 in both treatment groups. At endpoint, these scores had improved 73% in each group. There were no statistically significa nt differences between the two groups in the total symptom scores at a ny point during the study. Both treatments were effective in relieving individual nasal and nonnasal symptoms. Therapeutic response to treat ment was good or excellent in 82% of loratadine-treated children and i n 60% of terfenadine-treated children. Few adverse events were reporte d during the study; all were mild or moderate and were not significant ly different between the two treatment groups. There were no reports o f sedation or dry mouth in either group. Once-daily treatment with 5 o r 10 mg of loratadine was as effective as twice-daily treatment with 1 5 mg of terfenadine in improving the symptoms of seasonal allergic rhi nitis in children 3 to 6 years old. Both treatments were well tolerate d.