Abstract:

Objective To evaluate the efficacy and safety of bepotastine besilate in the treatment of chronic urticaria. Methods A randomized, double-blind, parallel-controlled clinical study was conducted in 5 centers. Patients were randomly assigned to 2 groups to be treated with bepotastine besilate 20 mg or loratadine 10 mg once a day, respectively, for 4 weeks. Visits were scheduled before and after 1, 2 and 4 weeks of treatment. Itching degree, number of wheals and diameter of the largest wheal were recorded for efficacy evaluation. Results Totally, 240 patients were enrolled and 227 patients completed the study. The response rate was 74.6% and 77.9% respectively in bepotastine besilate- and loratadine-treated patients, respectively（P > 0.05）. No significant difference was observed in the incidence of adverse reactions between bepotastine besilate- and loratadine-treated patients （12.8% vs. 17.9%, P > 0.05）. The main side effects were mild to moderate drowsiness, dry mouth, dizziness. Conclusion Bepotastine besilate is effective and safe for the treatment of chronic urticaria, with an efficacy and safety profile similar to that of loratadine.

Key words: loratadine