Bilastine as a reliable helper in the treatment of allergic rhinoconjunctivitis and urticaria even in younger children
Until recently, bilastine was indicated for the treatment of allergic rhinoconjunctivitis and urticaria only in patients over 12 years of age. However, current findings from valid studies demonstrate the safety and efficacy of its use even in younger individuals.
Pharmacological properties of bilastine
Bilastine, a 2nd generation antihistamine with high selectivity for H1 receptors, is indicated for the treatment of seasonal and perennial allergic rhinoconjunctivitis and urticaria. It is typically taken once daily orally and is characterized by a rapid onset of action and prolonged duration.
In the organism, it is not significantly metabolized and does not interact with the cytochrome P450 system, substantially limiting drug interactions. Additionally, dosing adjustments are not required for patients with renal or hepatic impairment. Bilastine passes through the blood-brain barrier minimally, and thus does not produce sedative effects, or only very minor sedative effects. It also does not exhibit negative anticholinergic and cardiotoxic effects.
Efficacy, safety, and appropriate dosing even in younger children
The results of the following studies were retrieved from the PubMed database on February 25, 2019.
A study analyzing the efficacy and safety of bilastine in adolescents included a total of 198 patients aged 12–18 years with seasonal or perennial rhinoconjunctivitis or urticaria. A total of 81 patients took bilastine at a dose of 20 mg, 68 of them for the full 12 months. Bilastine at a dose of 20 mg daily was shown to be safe in this age group and is therefore now approved for the treatment of adult patients and adolescents over 12 years of age.
Based on the results of an international randomized double-blind placebo-controlled study that evaluated the safety and efficacy of bilastine in children aged 2–12 years, this medication has recently been approved for children younger than 12 years (with a body weight ≥ 20 kg).
The appropriate dose was verified by an open pharmacokinetic study. Patients formed two age categories: 6–12 years (n = 24) and 2–6 years (n = 7), and took bilastine 10 mg once daily for 6 days. The study showed that this dose is safe for children under 12 years and is equivalent to a dose of 20 mg in adults.
Safety profile is largely similar to placebo
The safety of bilastine in children aged 2 to ≤ 12 years with allergic rhinoconjunctivitis or urticaria was tested on 506 subjects who took the medication at a dose of 10 mg daily for 12 weeks. Patients were divided into 3 age groups: 2–6 years (20% of patients), 6–9 years (40%), and 9–12 years (40%). The primary monitored parameter was the proportion of patients without adverse events caused by taking bilastine.
After 12 weeks, no significantly significant difference was observed in the proportion of patients without adverse events between the bilastine group and the placebo group (31.5 vs. 32.5%), nor among the individual age groups. According to questionnaire findings, patients taking bilastine had equally good sleep quality as those taking placebo.
Conclusion
As derived from the above, bilastine is suitable for the treatment of allergic rhinoconjunctivitis and urticaria not only in adult patients but also in children. In adults and adolescents over 12 years, a daily dose of 20 mg once daily orally is recommended, while in children aged 6–11 years (with a body weight ≥ 20 kg) a half dose, i.e., 10 mg once daily, is recommended. In all age groups, bilastine is highly effective, well tolerated, and demonstrably improves quality of life.
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Source: Church M. K., Tiongco-Recto M., Ridolo E., Novák Z. Bilastine: a lifetime companion for the treatment of allergies. Curr Med Res Opin 2019; 36(3): 445–454, doi: 10.1080/03007995.2019.1681134.
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