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

Zoltán Novák, Anahí Yáñez, Ildikó Kiss, Piotr Kuna, Miguel Tortajada-Girbés, Román Valiente, Analissa Brizuela, Jorge Maspero, Osvaldo Benhabib, Monica de Gennaro, Fernando Serrano, Raquel Gómez, Ines Antunez, Mónica Lambert, Matias Botelli, Amira Infante, Romina Municoy, Gabriel Tolcachier, Gabriel Gattolin, Lucila ToranzoFlorencia Daguerre, Eugenia Gevason, Sandra Vázquez, Ledit Arduso, Soledad Crisci, Maricel Martinich, Guillermina Ardusso, Carlos Baena Cagnani, Damir Erceg, Mirjana Turkalj, Davor Plavec, Vojko Rozmanic, Barbara Kvenic, Katalin Mohácsy, István Várkonyi, Mónika Gál, Ferenc Gönczi, Lilian Osváth, Edit Földi, Krisztina Szász, Ildikó Németh, László Barkai, Gyula Németh, Lajos Kósa, Beáta Tóth, Jadwiga Kaczmarek, Malgorzata Bochenska-Marciniak, Paula L. Pinto, Pedro Martins, Ana Romeira

Research output: Contribution to journalArticlepeer-review

41 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)493-498
Number of pages6
JournalPediatric Allergy And Immunology
Volume27
Issue number5
DOIs
Publication statusPublished - 1 Aug 2016

Keywords

  • allergic rhinoconjunctivitis
  • bilastine
  • chronic urticaria
  • paediatrics
  • randomized controlled trial
  • safety
  • tolerability

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