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Intranasal steroid safety (Master thesis)

Ζήσογλου, Μαρία/ Zisoglou, Maria

Subject and aim of the study: Intranasal corticosteroids (INCs) are used to treat the symptoms of allergic rhinitis, sinusitis and nasal polyps. As shown by numerous studies, INCs especially the newer generation have significantly reduced systemic bioavailability compared to oral or even inhaled corticosteroids, thus maintaining their efficacy while being safe. However, there is concern that these agents may enter the systemic circulation in sufficient concentration to cause adverse effects (AEs) with the available evidence from various studies to date not supporting this. The profile of adverse reactions to INCs consists mainly of mild and often transient low incidence AEs which are localised and usually involve nasal irritation and epistaxis. The second generation INCs (mometasone furoate nasal spray, fluticasone propionate, ticlesonide and fluticasone furoate) carry more favourable pharmacokinetic characteristics that further minimise systemic bioavailability (<1%) compared to the older ones thus limiting the risk of systemic AEs such as hypothalamic pituitary adrenal (HPA) axis suppression, increase in intraocular pressure (IOP) with possible glaucoma and growth retardation in children. The aim of this systematic review was to update the literature and scientifically establish the safety of INCs. Data sources: A systematic literature review of Medline, Embase, Web of Science, PubMed Central, Google Scholar and Cochrane Library was performed using a comprehensive search strategy that included all Food and Drug Administration (FDA) approved INCs and their AEs. The study design was developed using Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA). Review method: Α structured literature search was performed. Each study was scored for level of evidence using the Oxford Centre for Evidence Based Medicine (OCEBM) system. Data extracted included population size, study design, the drug - 11 - itself (dosage, route and frequency of administration) and the presence of HPA axis suppression, ocular symptoms and treatment--related adverse events. Results: A total of 8 studies met the inclusion criteria and all were systematic reviews and meta--analyses. The studies involved the use of INCs mainly in the form of a metered--dose nasal spray. No severe changes in cortisol levels, intraocular pressure, bone density or growth velocity were observed, nor were atrophic lesions or signs of epithelial damage observed during evaluation of the nasal mucosa. In one of the included systematic reviews involving an adult population, a significantly increased risk of epistaxis was observed in the meta--analysis performed in the treatment group compared with the control group (RR 1.56; 95% CI, 1.13--2.14; P = 0.007). Conclusions: FDA--approved INCs when administered at recommended doses are generally safe for use in both adults and children. Adverse reactions are generally limited to unpleasant local mild reactions. Systemic complications such as growth retardation, HPA axis suppression and visual changes due to administration are uncommon.