A Prospective, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Levocetirizine and Bepotastine in Chronic Spontaneous Urticaria

Abstract

Background: Management of chronic spontaneous urticaria (CSU) is challenging because of its unpredictable course and negative influence on the quality of life. Second-generation antihistaminics are the first-line treatment. Levocetirizine, a time-tested antihistaminic, has proven efficacy in CSU. Bepotastine, which was previously used for allergic rhinitis and conjunctivitis, has recently been tried in urticaria. It may be a better alternative to levocetirizine because of its long-term safety. Objectives: The aim of this study was to compare the efficacy and safety of levocetirizine and bepotastine in CSU. Materials and Methods: A randomized, active-controlled, open-label, prospective, interventional study was conducted on 70 patients of CSU. After initial clinical assessment and baseline investigations, bepotastine and levocetirizine were prescribed to separate groups of 35 patients for a period of 12 weeks. Urticaria Activity Score (UAS) and Dermatology Life Quality Index (DLQI) were used for assessing the severity of disease. Follow-up visits were planned for evaluating clinical improvement and adverse effects. Results were compared using Mann–Whitney U test and Fisher’s exact test. P < 0.05 was considered statistically significant. Results: The reduction in UAS and DLQI score in levocetirizine group was better than bepotastine group, and the results were statistically significant at 12 weeks (P = 0.0001). Incidence of adverse effects such as sedation and weight gain was higher in levocetirizine group at 12th week (P = 0.0003). Conclusion: The result of the study reveals the superiority of levocetirizine in terms of efficacy, i.e., reduction of UAS and DLQI scores. Bepotastine although slightly lower in efficacy shows better safety profile.