Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases

• Published in: Pediatric allergy and immunology Vol. 27; no. 5; pp. 493 - 498
• Main Authors: Novák, Zoltán, Yáñez, Anahí, Kiss, Ildikó, Kuna, Piotr, Tortajada-Girbés, Miguel, Valiente, Román
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.08.2016; Wiley Subscription Services, Inc
• Subjects: Adolescent; Adult; allergic rhinoconjunctivitis; Allergies; Benzimidazoles - therapeutic use; bilastine; Child; Child, Preschool; Chronic Disease; chronic urticaria; Double-Blind Method; Female; Follow-Up Studies; Histamine H1 Antagonists, Non-Sedating - therapeutic use; Humans; Male; paediatrics; Pediatrics; Pharmacology; Piperidines - therapeutic use; randomized controlled trial; Rhinitis, Allergic, Perennial - drug therapy; Safety; tolerability; Treatment Outcome; Urticaria - drug therapy; paediatrics; allergic rhinoconjunctivitis; safety; tolerability; chronic urticaria; bilastine; randomized controlled trial
• ISSN: 0905-6157; 1399-3038
• DOI: 10.1111/pai.12555

Background Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10‐mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. Methods In this phase III, multicentre, double‐blind study, children were randomized to once‐daily treatment with bilastine 10‐mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment‐emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). Results The primary hypothesis of non‐inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near‐equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. Conclusions Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria.