The clinical evidence of second-generation H1-antihistamines in the treatment of allergic rhinitis and urticaria in children over 2 years with a special focus on rupatadine.

INTRODUCTION: Many obstacles limit the development of pharmacologic studies in children, in particular ethical and practical issues. Therefore, although second-generation H1-antihistamines (sgAH) are recommended by international guidelines as first-line therapy in childhood allergies, most data on the efficacy of antihistamines in children has been extrapolated from studies in adult patients. AREAS COVERED: The current review focuses on rupatadine, a well-studied modern sgAH that has dual affinity for histamine H1-receptors and PAF receptors. In recent years, clinical efficacy and safety controlled-clinical trials on rupatadine were conducted in children and were based on latest current guidelines using validated tools of allergic rhinitis and urticaria. EXPERT OPINION: Children are not little adults since they present specific physiologic, metabolic, and developmental differences that should be evaluated in specific trials. The clinical evidence with rupatadine in children is the most recent and validated in accordance with current recommendations, with extensive direct data on efficacy and safety in pediatric populations over 2 years old.