Update meta-analysis on the efficacy and safety issues of fexofenadine

René Maximiliano Gómez; Pablo Moreno; Enrico Compalati; Giorgio Walter Canonica; Ignacio Javier Ansotegui Zubeldia

doi:10.1016/j.waojou.2023.100795

Update meta-analysis on the efficacy and safety issues of fexofenadine

World Allergy Organ J. 2023 Jul 11;16(7):100795. doi: 10.1016/j.waojou.2023.100795. eCollection 2023 Jul.

Authors

René Maximiliano Gómez^{1

2}, Pablo Moreno¹, Enrico Compalati³, Giorgio Walter Canonica^{4

5}, Ignacio Javier Ansotegui Zubeldia⁶

Affiliations

¹ Argentinean Association of Allergy & Clinical Immunology (AAAeIC), Argentina.
² Ayre Foundation, Salta, Argentina.
³ Casa di Cura Villa Serena, GVM Care & Research, Genoa, Italy.
⁴ Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy.
⁵ Asthma & Allergy Unit-IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Milan, Rozzano, Italy.
⁶ Department of Allergy and Immunology, Hospital Quironsalud Bizkaia, Bilbao, Spain.

Abstract

Background: Fexofenadine emerged as one of the most representative second generation histamine H1 antagonist drugs since the 1990s, with an outstanding efficacy and appreciable safety for the treatment of allergic patients. While allergic rhino-conjunctivitis represents the most frequent atopic disease globally, an update of fexofenadine efficacy and safety on this entity was proposed as a surrogate of allergic condition.

Methods: Double blind, placebo controlled, randomized clinical trials investigating the efficacy and safety of fexofenadine for the treatment of Allergic Rhinitis were searched in 5 major global databases. Eligibility criteria and characteristics, risk of bias, and validity assessment, data extraction and heterogeneity evaluation are described. Primary outcome selected corresponded to 12-reflective and instantaneous total symptom scores (TSS), besides morning instantaneous TSS and the frequency of reported adverse events (AEs); analysis was planned on the intention-to-treat population.Standardized mean differences of scoring systems were analyzed, and Cochran's Q statistic test and the I² test were assessed for heterogeneity.

Results: From the initial 83 identified records, 12 eligible studies were selected. In the evaluated patients, individuals receiving fexofenadine (1910) showed a significant reduction of TSS compared with those who received placebo (1777), change from baseline: standardized mean difference (SMD) -0.33; 95% CI-0.47 to -0.18, p < 0.0001. Morning instantaneous TSS also demonstrated lower symptoms (change from baseline: SMS -1.42; 95% CI -2.22 to -0.62, p = 0.0005). Heterogeneity was found across selected studies.Frequency of AEs was similar compared to placebo (OR = 1.04; 0.88-1.21), with no detection of heterogeneity across these 12 studies.

Conclusions: According to this new evidence, fexofenadine maintains its beneficial profile on signs and symptoms of patients with allergic conditions, as well as its attributes as one of the major candidates for an ideal antihistamine medication (including special conditions such as pregnancy and pre-school age), providing support to its over-the-counter condition in several countries.

Keywords: Efficacy; Fexofenadine; Histamine H1 antagonist; Non sedating; Safety.