Abstract

BackgroundAs a new generation antihistamine, fexofenadine has been widely used in allergic diseases. However, there is still a lack of collective evidence regarding the antihistamine effects and safety profiles of fexofenadine relative to other antihistamine drugs and placebo. Therefore, we aimed to systematically evaluate the antihistamine effects and safety of fexofenadine.MethodsAn electronic literature search of randomized controlled trials (RCTs) was performed using Embase, Cochrane and PubMed from establishment to January 1st, 2018. RCTs comparing the antihistamine effects or safety (adverse events, sedative effects, and cognitive/psychomotor function) of fexofenadine with either other antihistamines or placebo for healthy subjects and patients with allergy were selected.ResultsFifty-one studies of 14,551 participants met the inclusion criteria. When compared with the first-generation antihistamines, fexofenadine produced significantly lower adverse events frequency (OR = 0.446; 95% CI: 0.214 to 0.929, P = 0.031), significantly lower sedative effects frequency (OR = 0.265; 95% CI: 0.072 to 0.976, P = 0.046) and significantly less change of all cognitive/psychomotor function. When compared with the second-generation antihistamines, fexofenadine produced significantly marginal sedative effects (OR = 0.59; 95% CI, 0.38 to 0.93; P = 0.02) and significantly less change of most of the cognitive/psychomotor function. When compared with placebo, fexofenadine produced more significant antihistamine effects.ConclusionsFexofenadine has a positive antihistamine effect, which is probably no worse than the second-generation antihistamines. Fexofenadine probably has a favorable safety profile, which is more likely better than that of the first-generation antihistamines. There is lack of data to support that fexofenadine has a better overall safety profile compared to the second-generation antihistamines, however, some presently available evidence on sedative effects and certain aspects of cognitive/psychomotor function favors fexofenadine. Therefore, fexofenadine may be worthy of recommendation for safety related workers.

Highlights

  • As a new generation antihistamine, fexofenadine has been widely used in allergic diseases

  • The aim of this study was to analyze the antihistamine effects and safety of fexofenadine in healthy subjects and patients with allergic diseases including allergic rhinitis (AR), AA, chronic idiopathic urticaria (CIU), and atopic dermatitis (AD) when compared with other antihistamines or placebo

  • Our meta-analysis indicates that fexofenadine has better safety profiles compared to the second-generation antihistamines

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Summary

Introduction

As a new generation antihistamine, fexofenadine has been widely used in allergic diseases. There is still a lack of collective evidence regarding the antihistamine effects and safety profiles of fexofenadine relative to other antihistamine drugs and placebo. The incidence of allergic diseases such as allergic rhinitis (AR), allergic asthma (AA), chronic idiopathic urticaria (CIU) and atopic dermatitis (AD) has continued to rise over the past several decades, affecting a large number of people worldwide [1] Symptoms such as itching, sneezing, rhinorrhea and rhinobyon caused by allergic diseases usually lower the quality of life [2]. The aim of this study was to analyze the antihistamine effects and safety of fexofenadine in healthy subjects and patients with allergic diseases including AR, AA, CIU, and AD when compared with other antihistamines or placebo

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