Open-label safety assessment of bilastine in elderly patients with allergic rhinoconjunctivitis and/or urticaria
| Autor: | Ander Sologuren, Manuel Ruiz-Miján, Sonia Fernández, Luis Labeaga, Rosa Viñas, María Del Mar Forés, Susana E Riesgo, María Rosa Senán, Esther Cordón |
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| Rok vydání: | 2018 |
| Předmět: |
Pulmonary and Respiratory Medicine
Male 030213 general clinical medicine medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Urticaria Placebo 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Piperidines Internal medicine medicine Immunology and Allergy Humans 030212 general & internal medicine Prospective Studies Adverse effect Prospective cohort study Aged Conjunctivitis Allergic Bilastine Aged 80 and over business.industry Incidence (epidemiology) Incidence General Medicine Rhinitis Allergic Confidence interval Clinical trial chemistry Spain Histamine H1 Antagonists Benzimidazoles Female Open label business Follow-Up Studies |
| Zdroj: | Allergy and asthma proceedings. 39(4) |
| ISSN: | 1539-6304 |
| Popis: | Background 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. Objective As part of the risk management plan for bilastine, the safety profile of bilastine in the elderly was assessed. Methods 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. Results 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. Conclusion 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. |
| Databáze: | OpenAIRE |
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