Introduction

Antihistamines (AHs) have been the first-line drug in the treatment of allergic diseases. The second-generation AHs are preferred over the first-generation AHs due to lower sedative effects and more significant curative effect. As a new generation AH, fexofenadine is associated with positive antihistamine effects, no cardiotoxicity, lesser sedation and minimal adverse effects on the liver. However, there are no studies that compare the antihistamine and safety profile of fexofenadine with other AHs and placebo.

Aim

Assess the antihistamine effect and safety of fexofenadine in healthy subjects and in patients with allergic disease and compare with other AH drugs and placebo.

Method

Study Design

• Systematic review and meta-analysis of randomized controlled trials (RCTs)

Treatment Strategy

• Embase, Cochrane and PubMed databases were extensively searched to identify RCTs that compared the antihistamine effects or safety of fexofenadine with either other antihistamines or placebo for healthy subjects and patients with allergy.

Endpoints

• Antihistamine effects
• Frequency of adverse events (AEs)
• Frequency of sedative effects
• Change of cognitive/psychomotor function scores

Results

• The meta-analysis included 51 studies comprising 14,551 participants; of which 20 were parallel and 31 were cross-over trials
• When compared with the second-generation AHs, there was no significant difference in the inhibition rates of histamine-induced wheal (p=0.21) and histamine-induced flare (p=0.84)
• However fexofenadine produced significantly higher inhibition rate of histamine-induced wheal and histamine-induced flare as compared to placebo; p<0.00001 for both
• The frequency of AEs was significantly lower with fexofenadine as compared to first-generation AHs (OR = 0.446; p = 0.031). The frequency of AEs between fexofenadine vs second-generation AHs and placebo was similar
• The sedative effects frequency was also remarkably lower with fexofenadine vs first-generation and second-generation AHs (OR 0.265; p=0.046 and OR 0.578; p=0.017 respectively). The difference between fexofenadine and placebo was insignificant
• Fexofenadine resulted in significantly less change of cognitive/psychomotor function vs first-generation AHs; p<0.00001. The change in cognitive/psychomotor function score difference between fexofenadine vs second-generation AHs and placebo was not different

Conclusion

• The antihistamine effect of Fexofenadine was similar to the second-generation antihistamines with a better safety profile as compared to the first-generation antihistamines.
• Fexofenadine is associated with lower sedative effects and has favorable effect on cognitive/psychomotor function.
• Fexofenadine seems worthy of recommendation for safety related workers.

BMC Pharmacol Toxicol. 2019; 20: 72. Doi: 10.1186/s40360-019-0363-1