Bilastine, a novel nonsedative H1-receptor antagonist, can be used for the symptomatic treatment of chronic idiopathic urticaria (CU). The present study compared the clinical efficacy and safety of bilastine 20 mg vs. levocetirizine 5 mg and placebo in CU patients with moderate to severe symptoms.

It randomized 525 male and female subjects aged 18 to 70 years to receive bilastine 20 mg, levocetirizine 5 mg, or a placebo once daily for 28 days. It directed the patients to rate symptoms of pruritus, number of wheals and maximum size of wheals (on predefined scales) as reflective (over the past 12 h) symptoms twice daily for assessing change from baseline in the total symptoms scores (TSS) over 28 days. The study also assessed changes in reflective and instantaneous symptom scores, Dermatology Life Quality Index (DLQI), and CU-associated discomfort and sleep disturbance. It assessed safety according to adverse events, laboratory tests and electrocardiograms.

The study found:

• A greater reduction in patients′ mean reflective and instantaneous TSS from baseline from day 2 onwards of treatment in bilastine than placebo.
• Significant improvements in the DLQI, general discomfort and sleep disruption in bilastine-treated patients as compared with placebo-treated patients.
• Equal efficacy, safety and well tolerability of both the investigated drugs as compared with placebo.

This study proves bilastine 20 mg is a novel, effective, safe treatment option for CU management.

Source: Zuberbier T, Oanta A, Bogacka E, et al; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2010;65(4):516-28.