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) syru p (5 or 10 mg QD) was compared to terfenadine (CAS 50679-08-8.) suspen sion (30 mg b.i.d.) in a randomized, third party blind, parallel-group , multicenter trial Two hundred thirty-six children ages 6-12 years, w ith chronic allergic skin disorders were treated for 14 days. The pred ominant skin condition was atopic dermatidis (88 % of the efficacy pop ulation). Evaluation of efficacy was based on investigator and patient assessment of symptoms, overall condition of the disease, and therape utic response to treatment. After 7 and 14 days of treatment, and in t he endpoint analysis (last valid study visit for all patients) the dec reases from baseline in mean total sign/symptom scores, and all indivi dual symptoms, did not differ significantly (p > 0.05) between treatme nts. Itching improved 54 % in the loratadine group and 58 % in the ter fenadine group in the endpoint analysis. Forty-five percent of patient s treated with loratadine and 46 % of terfenadine-treated patients had complete or marked relief of their symptoms at endpoint. The efficacy of loratadine increased during the study, suggesting that patients di d not develop tolerance to the medication over the 14-day course of th erapy. Mild to moderate treatment-related adverse experiences were rep orted in 7/113 patients (6 %) treated with loratadine and 11/119 patie nts (9 %) treated with terfenadine. Single daily doses of 5 mg or 10 m g loratadine syrup were comparable to terfenadine suspension 30 mg twi ce daily for improving the symptoms of chronic allergic skin disorders in children. Loratadine was safe and well tolerated.