Bepotastine besilate was found to have comparatively greater efficacy than levocetirizine for reducing mean urticaria activity score and improving quality of life in chronic spontaneous urticaria patients in an interventional study.
Chronic spontaneous urticaria (CSU) affects approximately 15–20% of the population at least once during their lifetime. Antihistamines comprise the cornerstone treatment approach for this condition. While bepotastine besilate is a novel drug with multiple mechanisms of action, levocetirizine is a selective second-generation H1 receptor antagonist.
This randomized open-label parallel study, published in the Indian Journal of Dermatology, Venerology, and Leprology, compared the safety and efficacy of bepotastine besilate with levocetirizine in CSU patients.
Patient Characteristics
A total of 100 patients were enrolled in this study and were randomized into bepotastine besilate and levocetirizine groups. The bepotastine besilate and levocetirizine groups included 21 and 17 males, respectively. The mean age of participants was 39.66 ± 12.70 in the bepotastine besilate group and 37.04 ± 12.59 in the levocetirizine group. There were no statistically significant differences between the groups for baseline variables.
Urticaria Activity Scores in Bepotastine and Levocetirizine Groups
The percentage decrease in urticaria activity score 7 (UAS7) was significantly greater in the bepotastine group compared to the levocetirizine group at the end of the 2nd, 3rd, and 4th weeks of the treatment period.
Secondary Treatment Outcomes in Bepotastine and Levocetirizine Groups
The percentage improvement in scores on the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) was significantly greater in the bepotastine group compared to the levocetirizine group from baseline to the 4th week of the treatment period. Percentage improvement in the clinical global impression–improvement scale assessment score was significantly greater in the bepotastine group than in the levocetirizine group by the end of 2nd week and 4th week. There were no significant differences between the two groups for C-reactive protein levels and absolute eosinophil count
Safety Profile of Bepotastine and Levocetirizine Groups
Both groups were comparable in terms of an increase in hepatic alanine transaminase and aspartate transaminase at the baseline and by the end of 4th week. There was, however, a statistically significant difference between the two groups in the severity of daytime sedation. Levocetirizine group participants reported significantly higher occurrence of headaches compared to the bepotastine group.
In summary, the bepotastine group demonstrated a significant reduction in the severity of urticaria, improvement in CU-Q2oL scores, and improvement in the clinical global impression–improvement scale assessment score compared to the levocetirizine group.
Source:
Gayathri, E., Sowmya, P., Kumaravelu, P., & Veeraraghavan, M. (2023). Comparative study on the efficacy and safety of bepotastine besilate versus levocetirizine in chronic spontaneous urticaria: A randomised, open-label, parallel study. Indian Journal of Dermatology, Venereology, and Leprology, 89, 672–679. https://doi.org/10.25259/ijdvl_333_2021
