Bilastine is an orally administered,
second-generation antihistamine used in the symptomatic treatment of seasonal or perennial allergic rhinoconjunctivitis and
urticaria. In two well designed phase III trials, 14 days' treatment with
bilastine was associated with a significantly lower area under the effect curve (AUEC) for the reflective total symptom score (TSS) than placebo in patients with symptomatic
seasonal allergic rhinitis. Additionally, reflective nasal symptom scores were significantly lower in
bilastine than placebo recipients in patients with a history of
seasonal allergic rhinitis who were challenged with grass pollen
allergen in a single-centre, phase II study. Neither
bilastine nor
cetirizine was effective in the treatment of
perennial allergic rhinitis with regard to the mean AUEC for reflective TSS in another well designed phase III trial. However, results may have been altered by differences in some baseline characteristics and placebo responses between study countries. In another well designed phase III trial, compared with placebo,
bilastine was associated with a significantly greater change from baseline to day 28 in the mean reflective daily
urticaria symptom score in patients with
chronic urticaria. There were no significant differences in primary endpoint results between
bilastine and any of the active comparators used in these trials (i.e.
cetirizine,
levocetirizine and
desloratadine).
Bilastine was generally well tolerated, with a tolerability profile that was generally similar to that of the other
second-generation antihistamines included in phase III clinical trials.