title: Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: evidence review.
abstract: BACKGROUND
  The ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines development group examined the properties of oral H(1)-antihistamines and made proposals about an 'optimal' drug. Several criteria should be met by oral H(1)-antihistamines in terms of their pharmacological, and clinical efficacy and safety profiles.
  
  
  OBJECTIVE
  Bilastine, a new H(1)-antihistamine, has been approved in 28 European countries for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria in adults and children older than 12 years. To determine its potential place in therapy in the treatment of allergic rhinitis, this manuscript examines whether bilastine meets the criteria defined in the European Academy of Allergy and Clinical Immunology (EAACI)/ARIA proposals for oral H(1)-antihistamines.
  
  
  METHODS
  The optimal properties of oral H(1)-antihistamines and current ARIA recommendations for their use in allergic rhinitis are presented, as well as relevant pharmacological and clinical data for bilastine obtained from the published literature that specifically address the defined criteria.
  
  
  RESULTS
  Bilastine is a potent inhibitor of the histamine H(1) receptor. Data from preclinical studies have confirmed its selectivity for the histamine H(1) receptor over other receptors, and demonstrated antihistaminic properties in vitro and in vivo. Bilastine does not interfere with the cytochrome P450 system and is devoid of cardiac side effects. Studies in healthy volunteers and patients have shown that bilastine does not affect driving ability, cardiac conduction or alertness. In large pivotal randomized, placebo-controlled trials (RCTs), bilastine had a favourable safety profile. Bilastine 20 mg once daily improved all nasal and ocular symptoms of allergic rhinitis with greater efficacy than placebo and comparable to that of cetirizine and desloratadine. Moreover, bilastine was shown to improve quality of life, an important outcome of RCTs in allergic diseases. There were no significant changes in laboratory tests, electrocardiograms or vital signs. A potential limitation of this assessment of bilastine is that it is a literature-based review and the findings are dependent upon the quality of the published evidence.
  
  
  CONCLUSIONS
  Bilastine meets current EAACI/ARIA criteria for medications used in the treatment of allergic rhinitis.
authors.affiliation: University Hospital, Department of Respiratory Diseases, Hôpital Arnaud de Villeneuve, Montpellier, France. jean.bousquet@inserm.fr
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.forename: Ignacio
authors.initials: I
authors.lastname: Ansótegui
authors.forename: G Walter
authors.initials: GW
authors.lastname: Canonica
authors.forename: Torsten
authors.initials: T
authors.lastname: Zuberbier
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Baena-Cagnani
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
authors.forename: Alvaro A
authors.initials: AA
authors.lastname: Cruz
authors.forename: Sandra N
authors.initials: SN
authors.lastname: González
authors.forename: Piotr
authors.initials: P
authors.lastname: Kuna
authors.forename: Mario
authors.initials: M
authors.lastname: Morais-Almeida
authors.forename: Joaquim
authors.initials: J
authors.lastname: Mullol
authors.forename: Dermot P
authors.initials: DP
authors.lastname: Ryan
authors.forename: Mario
authors.initials: M
authors.lastname: Sánchez-Borges
authors.forename: Román
authors.initials: R
authors.lastname: Valiente
authors.forename: Martin K
authors.initials: MK
authors.lastname: Church
mesh_terms: D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D001249:Asthma / Q000150:complications / Q000188:drug therapy; D001562:Benzimidazoles / Q000627:therapeutic use*; D002648:Child; D006801:Humans; D010880:Piperidines / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000209:etiology
chemical_list: D018926:Anti-Allergic Agents; D001562:Benzimidazoles; D010880:Piperidines; C445659:bilastine