Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double‐blind, parallel‐group study

Abstract

Bilastine 20 mg once daily was significantly superior to placebo and comparable to cetirizine 10 mg in relieving symptoms of SAR, although it demonstrated a significantly better AE profile than cetirizine.

The role and choice criteria of antihistamines in allergy management – Expert opinion

“…In another randomized, double-blinded clinical trial, the efficacy of bilastine in the dose of 20 mg and cetirizine in the dose of 10 mg was compared with placebo in 681 patients from 61 European sites [3]. The results showed that bilastine in the dose of 20 mg administered once a day for 2 weeks was more effective than placebo in relieving the symptoms of seasonal allergic rhinitis.…”

“…This selection is of special importance in patients whose professions require concentration (such as driving), in which even a small sedative effect could lead to serious consequences ( Figure 4). Here, we present the expert opinion regarding the role of bilastine in the management of allergic rhinitis and urticaria as a non-sedative second generation antihistaminic drug of an extremely favourable safety profile which does not influence the ability to drive vehicles and other machines, does not have any interactions with other drugs or alcohol, and (in allergic patients) decreases drowsiness even when compared to placebo [3,4].…”

The Clinical Use of Cetirizine in the Treatment of Allergic Rhinitis

“…The efficacy of therapeutic doses of cetirizine has been compared in several studies with that of therapeutic doses of other commonly employed and newer preparations of SGAHs in adolescent/adult patients with SAR [55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72] and adolescent/adult and paediatric patients with PAR/PER [73,74,75,76,77,78,79,80]. The majority of these studies have compared the effects of the various antihistamines directly with that of cetirizine and/or placebo on the reduction of symptom severity scores, using different composites of the individual symptom scores as the main efficacy measure.…”

“…In contrast, other studies have not been able to demonstrate any significant differences between fexofenadine 120 mg or fexofenadine 180 mg and cetirizine 10 mg in the treatment of AR symptoms in patients exposed to pollen under experimental [64] or natural seasonal [65,66] conditions, although all active treatments were significantly more effective than placebo. Similarly, several studies investigating the less commonly employed or newer preparations of H 1 antihistamines in the treatment of symptoms in sensitized and symptomatic SAR patients during the grass/tree pollen season have not been able to show significant differences between therapeutic doses of cetirizine and mizolastine [67], emedastine [68], rupatadine [69], bilastine [70] or azelastine [71], although all active treatments were significantly effective in reducing specific total symptom severity scores from baseline or when compared with placebo. Azelastine has been administered as a nasal spray formulation and has produced conflicting data in two large multicentre comparative trials in the USA [71,72].…”

“…Several well-controlled trials have compared the efficacy of cetirizine with placebo and/or other H 1 antihistamines in adults and children with SAR and PAR/PER [43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80]. The majority of these trials have been conducted as double-blind, randomized, placebo-controlled, parallel-group studies in large groups of patients recruited from a single or multiple centres.…”