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A Prospective Randomized Non-Blinded Study of Safety and Efficacy of Bilastine Up-Dosing (40 mg) Versus Combination of Bilastine 20 mg With Levocetirizine 5 mg in the Treatment of Chronic Spontaneous Urticaria

Sneha B, Narasimhan M, Durai PCT, Ramakrishnan R

Indian journal of dermatology, 2024

62 participants · 1 citation

Abstract

INTRODUCTION: Chronic spontaneous urticaria (CSU) is the most commonly diagnosed skin condition in dermatology outpatient departments. Second-generation antihistamines are shown to be effective in the control of CSU. As per the guidelines, a combination of antihistamines is less recommended due to the lack of synergistic effect, though used widely. Exploring effective treatment options are crucial, given the challenges posed by CSU.

AIMS AND OBJECTIVES: To assess the safety and efficacy of Bilastine up-dosing versus combination of 20 mg Bilastine with 5 mg Levocetirizine in the treatment of CSU.

MATERIALS AND METHODS: This prospective randomized non-blinded comparative trial involved 62 patients, with 32 in group A and 30 in group B. Group A received Tablet Bilastine 20 mg bd, while Group B received a combination of Tablet Bilastine 20 mg and Tablet Levocetirizine 5 mg. Urticarial Activity Score 7 was performed at baseline and follow-up visits (every 2 weeks for 6 weeks).

RESULTS: Both groups had a higher number of male patients in the 20-30 years age group. Angioedema was present in 15.6% of group A and 23.3% in group B. After 6 weeks, both the groups showed a significant improvement in UAS 7 scores (P value <0.05). Group A demonstrated a remarkable reduction in UAS 7 from 19.4% to 0.03% with minimal side effects.

CONCLUSION: Bilastine up-dosing proved to be efficient, secure, and well tolerated when compared to the combined dose of Levocetirizine 5 mg and Bilastine 20 mg,…

How strong is the evidence?

Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 62 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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