A double-arm, randomized, and controlled trial to compare the efficacy and safety of bepotastine with levocetirizine in patients of chronic spontaneous urticaria

ABSTRACT

Background: Second generation antihistamines are first line therapy for chronic spontaneous urticaria (CSU). Sedation has been always a concern as a side effect of antihistamine for both patients and treating dermatologist. It is always better to prefer non-sedative antihistamine for CSU. Bepotastine is such promising non-sedative agent. Aim and Objectives: The objective of the study was to compare the efficacy and safety of bepotastine and levocetirizine in patients of CSU. Materials and Methods: This is a double arm, open label, randomized, and controlled study. Out of 99 patients, 50 patients belonged to Group A while 49 belonged to Group B. Subjects in Group A received bepotastine 10 mg twice daily while subjects in Group B received levocetirizine 5 mg once daily for 8 weeks. Patients were evaluated at baseline, day 14, day 28, and day 56 using Urticaria Activity Score (UAS) and Urticaria Control Test (UCT) for efficacy; and visual analog scale (VAS) for safety, that is, sedation. Results: The fall in mean UAS scores was statistically significant at day 14, day 28, and day 56 for both Groups A and B (P < 0.05) on intragroup comparison. While comparing the overall improvement between the two groups, there was no significant difference in UAS and UCT score at day 14, day 28, and day 56 between Group A and Group B, respectively (P > 0.05). At day 56, there was significant difference in mean VAS of Group A and B. Only one patient in Group B developed headache. Conclusion: Thus, both levocetirizine and bepotastine are equally effective for the treatment of CSU. Bepotastine has less sedative potential than levocetirizine.