A comparative study of the efficacy and safety of loratadine syrup and terfenadine suspension in the treatment of 3- 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 compared in a third-party-blind, randomized, parallel-group study. A total of 96 children were included in the efficacy analysis: 49 children received 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 nasal and non-nasal 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 significant differences between the two groups in the total symptom scores at any point during the study. Both treatments were effective in relieving individual nasal and nonnasal symptoms. Therapeutic response to treatment was good or excellent in 82% of loratadine-treated children and in 60% of terfenadine-treated children. Few adverse events were reported during the study; all were mild or moderate and were not significantly different between the two treatment groups. There were no reports of sedation or dry mouth in either group. Once-daily treatment with 5 or 10 mg of loratadine was as effective as twice-daily treatment with 15 mg of terfenadine in improving the symptoms of seasonal allergic rhinitis in children 3 to 6 years old. Both treatments were well tolerated.
Lutsky
B N
BN
Schering Plough Research Institute, Kenilworth, New Jersey.
Klöse
P
P
Melon
J
J
Menardo
J L
JL
Molkhou
P
P
Ronchetti
R
R
Suonpää
J
J
Wahn
U
U
Wessel
F
F
D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D017336:Loratadine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D013535:Suspensions; D016593:Terfenadine / Q000009:adverse effects / Q000627:therapeutic use*
D013535:Suspensions; D017336:Loratadine; D016593:Terfenadine