Autores
Zoltán Novák, Anahí Yáñez, Ildikó Kiss, Piotr Kuna, Miguel Tortajada‐Girbés, Román Valiente, “Bilastine Paediatric Safety Study Group”, 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 Toranzo, Florencia 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, Izabela Bogus‐Buczynska, Krystyna Sobczynska, Katarzyna Czerwinska, Andrzej Emeryk, Malgorzata Bartkowiak‐Emeryk, Iwona Czerwińska‐Pawluk, Madgalena Kowalska, Wioletta Zagorska, Tomasz Grzela, Katarzyna Grzela, Irena Wojciechowska, Piotr Kusiak, Magdalena Mroczek, Joao Almeida, Ana M Pereira, Luis Araújo, Mariana Couto, Paula L Pinto, Jorge Fernandes, Pedro Martins, Sara Prates, Ana Romeira, Sónia Rosa, Miguel Paiva, Manuel Porcar, David Aínsa, Esther Silgo, Cándido García‐López, Susana Villalonga, Laura Uixera, Andreu Belmonte, Leyre Martí, Ana M Plaza, Mónica Piquer, Teresa Giner, Joana Claverol, Jaime Lozano, Marta Sánchez
Fecha de publicación
2016/8
Revista
Pediatric Allergy and Immunology
Volumen
27
Número
5
Páginas
493-498
Descripción
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 …
Artículos de Google Académico
Z Novák, A Yáñez, I Kiss, P Kuna, M Tortajada‐Girbés… - Pediatric Allergy and Immunology, 2016