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Yanai K.,Tohoku University | Rogala B.,Medical University of Silesia, Katowice | Chugh K.,Institute of Child Health | Paraskakis E.,Democritus University of Thrace | And 2 more authors.
Current Medical Research and Opinion | Year: 2012

Objective: To conduct a systematic review of evidence supporting the safety profiles of frequently used oral H1-antihistamines (AHs) for the treatment of patients with histamine-release related allergic diseases, e.g. allergic rhinitis and urticaria, and to compare them to the safety profiles of other medications, mostly topical corticosteroids and leukotriene antagonists (LTRA). Research design and methods: Systematic search of the published literature (PubMed) and of the regulatory authorities databases (EMA and FDA) for oral AHs. Results: Similarly to histamine, antihistamines (AHs) have organ-specific efficacy and adverse effects. The peripheral H1-receptor (PrH1R) stimulation leads to allergic symptoms while the brain H1-receptor (BrH1R) blockade leads to somnolence, fatigue, increased appetite, decreased cognitive functions (impaired memory and learning), seizures, aggressive behaviour, etc. First-generation oral AHs (FGAHs) inhibit the effects of histamine not only peripherally but also in the brain, and additionally have potent antimuscarinic, anti-α-adrenergic and antiserotonin effects leading to symptoms such as visual disturbances (mydriasis, photophobia, and diplopia), dry mouth, tachycardia, constipation, urinary retention, agitation, and confusion. The somnolence caused by FGAHs interferes with the natural circadian sleepwake cycle and therefore FGAHs are not suitable to be used as sleeping pills. Second-generation oral AHs (SGAHs) have proven better safety and tolerability profiles, much lower proportional impairment ratios, with at least similar if not better efficacy, than their predecessors. Only SGAHs, and especially those with a proven long-term (e.g., ≥12 months) clinical safety, should be prescribed for young children. Evidence exist that intranasally applied medications, like intranasal antihistamines, have the potential to reach the brain and cause somnolence. Conclusions: Second-generation oral antihistamines are the preferred first-line treatment option for allergic rhinitis and urticaria. Patients taking SGAHs report relatively little and mild adverse events even after long-term continuous treatments. An antihistamine should ideally possess high selectivity for the H 1-receptor, high PrH1R occupancy and low to no BrH1R occupancy. © 2012 Informa UK Ltd. Source

Boev R.,UCB Farchim SA | Song D.,Sanofi S.A. | Bedenbaugh A.,UCB Pharma | Haeusler J.-M.,UCB GmbH
Current Medical Research and Opinion | Year: 2011

Objective: Despite a plethora of published data on levocetirizine, no meta-analyses exist on the effect of study design, and covariates like age, gender, and baseline symptom severity on treatment response. The objective of this study was the efficacy of levocetirizine 5mg tablets and matching placebo at reducing allergy symptoms in adult subjects with seasonal allergic rhinitis under various pollen exposure study conditions and by age, gender and baseline symptom severity. Methods: This was a meta-analysis of original reports from randomized, double-blind, placebo-controlled studies. Clinical studies without detailed reports, open-label, non-randomized and non-controlled studies, or paediatric studies, were excluded. Study subjects were divided into an environmental exposure (EE) group or a natural exposure (NE) group. Results: Data from 3640 subjects were analysed (n2174 for levocetirizine, n1466 for placebo). The overall results confirmed the efficacy of levocetirizine 5mg, with an approximately 40 symptom score improvement from baseline, in both the EE and NE groups. While levocetirizine showed no gender- or age-related differences in efficacy, female subjects responded better to placebo in the EE, but not in the NE group; younger subjects (<30 years of age) responded less favourably to placebo compared with older subjects (50 years of age). Levocetirizine was consistently superior to placebo regardless of baseline symptom score levels. The highest significance levels between the active and placebo groups were observed in subjects sensitized to animal dander and grass. Conclusions: Differences between an oral antihistamine and placebo in clinical studies of allergic rhinitis might be due to a different response to placebo rather than to the active drug. Levocetirizine seems to have consistent efficacy regardless of age, gender, and baseline scores. © 2011 Informa UK Ltd. Source

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