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

• Published in: Clinical and experimental allergy 2009-09, Vol.39 (9), p.1338-1347
• Main Authors: Kuna, P., Bachert, C., Nowacki, Z., Van Cauwenberge, P., Agache, I., Fouquert, L., Roger, A., Sologuren, A., Valiente, R.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; bilastine; Biological and medical sciences; cetirizine; Cetirizine - administration & dosage; Cetirizine - adverse effects; Child; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; H1 antihistamine; Histamine H1 Antagonists, Non-Sedating - administration & dosage; Histamine H1 Antagonists, Non-Sedating - adverse effects; Humans; Male; Medical sciences; Middle Aged; nasal symptoms score; Non tumoral diseases; non-nasal symptoms score; Otorhinolaryngology. Stomatology; Piperidines - administration & dosage; Piperidines - adverse effects; Receptors, Histamine H1 - metabolism; Rhinitis, Allergic, Seasonal - drug therapy; Rhinitis, Allergic, Seasonal - metabolism; seasonal allergic rhinitis; Time Factors; total symptom score; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology
• ISSN: 0954-7894; 1365-2222
• DOI: 10.1111/j.1365-2222.2009.03257.x

Summary Background Bilastine is a new non‐sedative H1 receptor antagonist, indicated for the treatment of allergic rhinitis (AR) (seasonal and perennial). Objective To assess and compare the efficacy and safety of bilastine 20 mg vs. cetirizine 10 mg and placebo in relieving the symptoms of seasonal allergic rhinitis (SAR). Methods Overall, 683 SAR patients, aged 12–70 years, were randomized to a double‐blind treatment with bilastine 20 mg, cetirizine 10 mg or placebo, once daily for 14 days, in 61 centres across Europe. Patients recorded reflective (over the past 12 h) and instantaneous nasal (obstruction, rhinorrhoea, itching and sneezing) and non‐nasal (ocular tearing, redness and itching) symptom scores (NSS and NNSS, respectively) twice daily, according to a pre‐determined severity scale to provide reflective and instantaneous total symptom scores (TSS). The primary efficacy measure was the area under curve (AUC) of reflective TSS over 14 days of treatment (TSS‐AUC0−14 days). Secondary efficacy measures included mean change from baseline in TSS, NSS and NNSS; discomfort caused by AR; and investigator's clinical global impression of the treatment. Safety was assessed according to adverse events (AEs), laboratory tests and electrocardiograms. Results The mean TSS‐AUC0−14 days (score × day) was reduced in bilastine‐ and cetirizine‐treated groups to a similar and significantly greater extent, compared with placebo (76.5, 72.3 and 100.6, respectively; P