Bilastine: new insight into antihistamine treatment

Ridolo, Erminia; Montagni, Marcello; Bonzano, Laura; Incorvaia, Cristoforo; Canonica, Giorgio Walter

doi:10.1186/s12948-015-0008-x

Cited by 53 publications

(29 citation statements)

References 37 publications

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“…These results confirm that, in children, bilastine 10 mg has a safety and tolerability profile similar to that of placebo [5]. In adults, bilastine at the recommended dose of 20 mg has an excellent safety profile, with good tolerability and no sedative effects or cardiotoxicity [2,[7][8][9].…”

Section: Discussionsupporting

confidence: 70%

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Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Rodríguez¹,

Vozmediano²,

García-Bea

et al. 2020

Eur J Pediatr

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Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years. Pharmacokinetic data for children aged 6-11 years were extracted post hoc from a study in which children (2-11 years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10 mg/day). Maximum plasma concentration (C max) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). Safety data for children aged 6-11 years were extracted post hoc from a phase III randomized controlled trial of children (2-11 years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10 mg or placebo for 12 weeks. Exposure and C max values were similar for children (6-11 years) and adults: median pediatric/adult ratios for AUC 0-24 and C max were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo. Conclusion: Pharmacokinetic and safety analyses in children aged 6-11 years support the suitability of the pediatric dose of bilastine 10 mg and confirm that the safety profiles of bilastine and placebo are similar. What is Known: • Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults (20 mg/day) and children aged ≥ 6 years (10 mg/day). • An ontogenic model based on adult data and pharmacokinetic/pharmacodynamic simulations supported the selection of a bilastine dose of 10 mg/day in children aged 2-11 years. Bilastine 10 mg/day was shown to have a safety profile similar to that of placebo in a large phase III randomized clinical trial in children aged 2-11 years. What is New: • As bilastine is approved in Europe for children aged ≥6 years, the current study reports the results of two post hoc analyses of pharmacokinetic and safety data in children aged 6-11 years. • Analysis of pharmacokinetic and safety data in children aged 6-11 years supports the suitability of the pediatric dose of bilastine 10 mg and confirms that its safety profile is similar to that of placebo.

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Section: Discussionsupporting

confidence: 70%

“…Recently, bilastine has also been approved in Mexico for children aged ≥ 2 years. The efficacy of bilastine is similar to that of other second-generation oral H 1 -antihistamines [7][8][9].…”

Section: Introductionmentioning

confidence: 58%

Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Rodríguez¹,

Vozmediano²,

García-Bea

et al. 2020

Eur J Pediatr

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“…7 Headache, drowsiness, dizziness, and fatigue are the most common adverse events reported by patients with an incidence similar to placebo. 17…”

Section: Safety Dosage and Adverse Effectsmentioning

confidence: 99%

Role of bilastine in allergic rhinitis: a review

Dhingra

2020

Int J Otorhinolaryngol Head Neck Surg

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The prevalence of allergic diseases is increasing globally, most particularly in middle to low-income countries. Allergic rhinitis and urticaria are common allergic diseases that may have a major negative impact on patient's quality of life. Bilastine, a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action. In the fasting state bilastine is quickly absorbed, but the absorption is slowed when it is taken with food or fruit juice. Therefore, it is recommended that bilastine is taken at least one hour before and no sooner than two hours after a meal. This review article describes about the role of bilastine in allergic reactions.

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“…Относится к производным пиперидина и структурно не является производным от других доступных в настоящее время антигистаминных препаратов. Биластин проявляет сильную и специфическую H1-антигистаминную активность [10]. Сродство к рецептору H1 в 3 и 6 раз выше, чем у цетиризина и фексофенадина соответственно [11].…”

Section: антигистаминные препараты/никсарunclassified

Modern aspects of treatment of allergic rhinitis

Шабанов

Fedoseeva

2019

Medicinskij sovet

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The importance of allergic diseases is due to their increasing prevalence in both developed and developing countries. The prevalence of allergic diseases in most countries of the world is 10–30% among urban and rural population. In the regions of Russia, the prevalence of allergic diseases reaches 19–40% among the adult population and over 27% among children and adolescents. The article deals with the main aspects of the pathogenesis of allergic rhinitis as the most common allergic pathology. The features of antihistamine therapy with modern drugs of the 2nd generation and their influence on the links of the inflammatory process are considered. The data of studies of the effectiveness and safety of the original drug bilastine. Given the use cases bilastine in clinical practice.

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Bilastine: new insight into antihistamine treatment

Cited by 53 publications

References 37 publications

Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Role of bilastine in allergic rhinitis: a review

Modern aspects of treatment of allergic rhinitis

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