Comparative study of the efficacy and safety of loratadine syrup and terfenadine suspension in the treatment of chronic allergic skin diseases in a pediatric population.
The safety and efficacy of loratadine (Sch 29851, CAS 79794-75-5) syrup (5 or 10 mg QD) was compared to terfenadine (CAS 50679-08-8) suspension (30 mg b.i.d.) in a randomized, third party blind, parallel-group, multicenter trial. Two hundred thirty-six children ages 6-12 years, with chronic allergic skin disorders were treated for 14 days. The predominant skin condition was atrophic dermatitis (88% of the efficacy population). Evaluation of efficacy was based on investigator and patient assessment of symptoms, overall condition of the disease, and therapeutic response to treatment. After 7 and 14 days of treatment, and in the endpoint analysis (last valid study visit for all patients) the decreases from baseline in mean total sign/symptom scores, and all individual symptoms, did not differ significantly (p > 0.05) between treatments. Itching improved 54% in the loratadine group and 58% in the terfenadine group in the endpoint analysis. Forty-five percent of patients treated with loratadine and 46% of terfenadine-treated patients treated had complete or marked relief of their symptoms at endpoint. The efficacy of loratadine increased during the study, suggesting that patients did not develop tolerance to the medication over the 14-day course of therapy. Mild to moderate treatment-related adverse experiences were reported in 7/113 patients (6%) treated with loratadine and 11/119 patients (9%) treated with terfenadine. Single daily doses of 5 mg or 10 mg loratadine syrup were comparable to terfenadine suspension 30 mg twice daily for improving the symptoms of chronic allergic skin disorders in children. Loratadine was safe and well tolerated.