Systematic Review on the Efficacy of Fexofenadine in Seasonal Allergic Rhinitis: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Clinical Trials

Abstract

Rationale: Evidence-based medicine represents the effort to highlight the best intervention for patients, clinicians, and policy makers, each from their respective viewpoint, to solve a particular health condition. According to a recently diffused grading system of evidence and recommendations for medical interventions, efficacy and safety represent 2 of the most important features to consider, and data from meta-analyses of randomized controlled clinical trials (RCTs) is the strongest supporting demonstration. Fexofenadine has been used for its efficacy and safety in the treatment of allergic rhinitis (AR) for many years although no meta-analyses supporting its use currently exist. The aim of this study is to assess for the first time the efficacy and safety of fexofenadine in the treatment of AR by means of a meta-analytic analysis of existing RCTs. Since specific evidence should be provided to address recommendations in a pediatric population, the quality of the estimates of this subgroup analysis is assessed. Methods: All double-blind, placebo-controlled randomized trials assessing the efficacy of fexofenadine in AR were searched for in OVID, Medline, and Embase databases up to December 2007. Outcomes were extracted from original articles; when this information was not available, the authors of each trial were contacted. Some graphics were digitalized. The RevMan 5 program was used to perform the analysis. GradePro 3.2.2 was used to assess the quality of the evidence for a pediatric population. Results: Of 2,152 identified articles, 20 were potentially relevant trials. Eight studies satisfied the inclusion criteria and were included in the meta-analysis. The main reasons for exclusion were: unnatural exposure, strong study limitations, an atypical outcome measurement, a design for other outcomes, and not being a placebo-controlled, single-blind study. Seven trials investigated a mixed population of adults and children, 1 trial investigated only children, and 1 trial only adults. In 1,833 patients receiving fexofenadine (1,699 placebo), a significant reduction of the daily reflective total symptom scores (TSS) (SMD –0.42; 95% CI –0.49 to –0.35, p < 0.00001) was found. Positive results were also found for morning instantaneous TSS and individual nasal symptom scores (sneezing, rhinorrhea, itching, and congestion). The safety analysis did not show a significant difference in reported adverse events (AE) between the active and placebo treatment groups (OR = 1.03; 95% CI 0.87–1.22, p = 0.75). A very low heterogeneity between the studies was detected, so a fixed-effects model was used. The mean quality level of the included trials was medium. Specific information for a pediatric population may be assumed with a moderate quality of evidence from only 1 study and with a low quality of evidence, mainly due to indirectness, from the others. Conclusions: This study has 5 major strengths: it represents the first attempt to evaluate the efficacy and safety of fexofenadine in the treatment of AR by means of a meta-analysis...

A Nasally Applied Cellulose Powder in Seasonal Allergic Rhinitis in Adults with Grass Pollen Allergy: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study

“…These guidelines, however, do not discuss non-pharmacological products, probably due to the scarcity of studies of acceptable scientific quality in this context. The degree of symptom reduction in the present study is comparable with a usual result in placebo-controlled studies of nasal steroids and oral antihistamines [17,18]. Hence, considering the complete absence of significant adverse effects and, with a reservation for the huge imbalance in the number of studies performed compared with intranasal steroid treatment, we suggest that this kind of barrier protection may be tried as an early choice in the treatment of SAR, particularly in the mild/moderate stages of the disease, corresponding to the selected contingent in the present study; our inclusion criteria selected cases with mild/moderate disease, and the degree of severity also comprised the majority of patients with allergic rhinitis [4].…”

Management of ocular allergy

“…Oral antihistamines are frequently used in case of allergic comorbidities such as rhinitis and are used in almost one‐third of the patients with ocular symptoms . Drugs such as loratadine, desloratadine, and fexofenadine are highly effective for the treatment of allergic rhinoconjunctivitis (ARC) (Table ). Most of the SRs have addressed total symptoms scores, without evaluating impact on specific ocular symptoms.…”

Safety and efficacy of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis: a randomized controlled trial

“…Therefore participants received pharmacological treatment for rhino-conjunctivitis according to the Japanese Guidelines for Allergic Rhinitis21 without limitations except for oral corticosteroids in addition to OIT. Many RCTs have shown that antihistamines (Levocetirizine hydrochloride, Fexofenadine hydrochloride), nasal steroid sprays (Mometasone furoate, Fluticasone furoate), ocular antihistamine drops (Ketotifen fumarate, Olopatadine hydrochloride) and ocular steroid drops (Fluorometholone) used as rescue medications improve rhino-conjunctive symptoms for pollinosis27282930. Thus, the rhino-conjunctive symptoms in the placebo and active groups may have been suppressed to the same extent by rescue medications.…”