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Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria

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Bilastine is an H1-antihistamine approved for symptomatic treatment of patients with allergic rhinoconjunctivitis or urticaria. The safety profile of bilastine in clinical trials of allergic rhinoconjunctivitis or urticaria, assessed by type and frequency of adverse events (AE), was similar to that of placebo.


As part of the risk management plan for bilastine, the safety profile of bilastine in the elderly was assessed.


A prospective, multicenter, observational, open-label, 3-month follow-up study was performed to assess the safety profile of bilastine 20 mg in patients aged ≥65 years with allergic rhinoconjunctivitis and/or urticaria.


A total of 74 of 146 patients (50.7%) reported 129 treatment-emergent AEs (TEAE) during the study period. The incidence of TEAEs was low, with monthly and quarterly rates of 0.29 (95% confidence intervals [CI], 0.229‐0.367) and 0.88 (95% CI, 0.688‐1.100), respectively. Monthly and quarterly incidence rates were 0.04 (95% CI, 0.016‐0.082) and 0.12 (95% CI, 0.048‐0.246), respectively, for related TEAEs (eight TEAEs in seven patients) and were 0.02 (95% CI, 0.003‐0.048) and 0.05 (95% CI, 0.010‐0.143), respectively, for serious TEAEs (five TEAES in three patients). All serious TEAEs were considered to be unrelated to bilastine.


Bilastine 20 mg showed a favorable safety profile with a low incidence of TEAEs in patients aged ≥65 years. The results were in accordance with the known safety profile of bilastine 20 mg and incidence of AEs reported in previous studies and described in the approved summary of product characteristics.
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Keywords: allergic rhinoconjunctivitis; bilastine; elderly; safety; urticaria

Document Type: Research Article

Affiliations: 1: From the Pharmacovigilance Unit, Faes Farma S. A., Leioa-Bizkaia, Spain 2: Centre d'Atenció Primaria Amadeu Torner, Barcelona, Spain 3: Centro de Salud Los Cármenes, Madrid, Spain 4: Centre d'Atenció Primaria El Clot, Barcelona, Spain 5: Medical Department, Faes Farma S. A., Leioa-Bizkaia, Spain

Publication date: 01 July 2018

This article was made available online on 20 March 2018 as a Fast Track article with title: "Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria".

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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