Evaluation of treatment satisfaction in children with allergic disease treated with an antihistamine: an international, non-interventional, retrospective study

Histamine H(1)-receptor antagonists (antihistamines) have been shown to be efficacious and safe in children and are recommended as first-line treatment for the symptoms of allergic rhinitis and urticaria. No published study to date has directly compared satisfaction with the different antihistamines in children in a real-life clinical setting. This study aimed to investigate parent and physician satisfaction with the efficacy and tolerability of oral antihistamine treatment in children and to compare satisfaction between levocetirizine and the other antihistamines used by children in this cohort. This was an international Observational Survey in Children with Allergic Rhinitis (OSCAR).

Children aged 2-12 years, with a history of an allergic condition leading to a consultation, were enrolled from 424 primary-care/specialist allergy clinics across Bulgaria, India, Portugal, Romania, Russia, South Korea and Spain. At the consultation, parents and physicians of eligible children completed questionnaires evaluating their satisfaction with specific antihistamines currently employed for management of the child's allergic condition, as well as their intention for future use of that treatment.

Parents' satisfaction scores for efficacy, tolerability and global satisfaction with the antihistamine used were primary study outcomes, while physicians' satisfaction scores for the same measures were secondary outcomes. Other secondary outcomes were parents' rating of the impact of the antihistamine treatment on their child's sleep and school performance, and parents' and physicians' willingness to use/recommend the same antihistamine in the future. A total of 4581 patients were enrolled; 3048 (66.5%) had allergic rhinitis (55.9% persistent allergic rhinitis and 44.1% intermittent allergic rhinitis), and 663 (14.5%) had urticaria as primary conditions. Additionally, 2465 patients (53.8%) suffered from other allergic diseases, including allergic asthma (33.3%), atopic dermatitis (17.6%), food allergy (5.3%), other allergies (5.0%) and drug hypersensitivity (2.0%).

Parents' and physicians' satisfaction scores were closely concordant and demonstrated significantly greater global satisfaction for the second-generation antihistamines than for the first-generation antihistamines. Levocetirizine (n = 2339) and fexofenadine (n = 42) generally scored highest for efficacy, tolerability and global satisfaction, as well as for impact on the child's ability to function at school, quality of school activities and quality of sleep. Furthermore, >97% of parents and physicians indicated their desire to continue or recommend the use of levocetirizine in the future. Somnolence, the most commonly reported adverse event in this survey, was observed predominantly in patients treated with first-generation antihistamines. Among second-generation antihistamines, reports of somnolence were most frequent in the cetirizine group. Second-generation antihistamines have a better risk:benefit ratio than first-generation antihistamines, indicating that the latter should be avoided or their use limited in children whenever possible.

Levocetirizine and fexofenadine were perceived by parents and physicians to produce significantly higher treatment satisfaction than the majority of the other antihistamines with respect to overall efficacy and tolerability, and impact on the child's sleep and school activities. The newer antihistamine levocetirizine seems to be a preferred and appropriate future treatment choice for children with allergic diseases.

CITA DEL ARTÍCULO  Clin Drug Investig. 2010;30(1):15-34. doi: 10.2165/11530910-000000000-00000