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Fexofenadine: review of safety, efficacy and unmet needs in children with allergic rhinitis

ABSTRACT: Allergic rhinitis (AR) is the most common undiagnosed chronic condition in children. Moderate/severe AR symptoms significantly impair quality of life, and cause sleep disruption, absenteeism and decreased productivity. Additionally, untreated AR predisposes children to asthma and other chronic conditions. Although intranasal corticosteroids are the most effective pharmacologic treatment for AR, oral antihistamines are often preferred. First-generation antihistamines may be chosen to relieve AR symptoms as they are inexpensive and widely available; however, they cause sedative and cardiovascular negative effects due to poor receptor selectivity. Therefore, second-generation antihistamines were developed to reduce adverse effects while retaining efficacy. There are fewer clinical trials in children than adults, therefore, efficacy and safety data is limited, particularly in children under 6 years, highlighting the need to generate these data in young children with AR. Fexofenadine, a highly selective second-generation antihistamine, effectively alleviates symptoms of AR, is non-sedating due to decreased blood–brain barrier permeability, and is devoid of cardiovascular side effects. Importantly, fexofenadine relieves the ocular symptoms of allergic conjunctivitis, which occur concomitantly with AR, improving quality of life. Overall, fexofenadine displays a favorable safety profile and results in greater treatment satisfaction in children compared with other second-generation antihistamines. This review aimed to evaluate and compare the safety and efficacy of fexofenadine with other available first- and second-generation antihistamines in children with AR.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13223-021-00614-6.

SUBMITTER: Meltzer E

PROVIDER: S-EPMC8561980 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Bilastine is a non-sedating second generation H1 oral antihistamine (OAH) for treating allergic rhinitis (AR) patients. The effect of bilastine has not previously been evaluated in a meta-analysis. The aim of this review was to determine the efficacy and safety of bilastine in treating AR. An electronic literature search was performed using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Science Direct and Google Scholar up to March 2021. Randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy were included. The included studies must have diagnosis of AR established by clinicians and the outcomes must have a minimum of 2 weeks of follow-up period. The primary outcomes assessed were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QOL) and adverse events. The risk of bias and quality of evidence for all studies were appraised. The meta-analysis was done using Review Manager 5.3 software based on the random-effects model. The search identified 135 records after removal of duplicates. Following screening and review of the records, fifteen full-text articles were assessed for eligibility. Five trials involving 3,329 patients met the inclusion criteria. Bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QOL but has comparable efficacy with other OAHs in TSS, NSS, NNS, rhinitis discomfort score and QOL. There was no difference in adverse effects when bilastine was compared against placebo and other OAHs except for somnolence. Bilastine has fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality. Bilastine is effective and safe in treating the overall symptoms of AR with comparable efficacy and safety with other OAHs except somnolence. Whilst bilastine has similar efficacy to cetirizine, somnolence is notably less in bilastine.

Project description:INTRODUCTION:The safety and efficacy of fluticasone furoate nasal spray (FFNS) for the symptoms of seasonal and perennial allergic rhinitis have been previously demonstrated in several clinical studies. The objective of this pilot study was to compare the efficacy and safety of FFNS 110 mcg once daily with placebo in patients with irritant (non-allergic) rhinitis triggered predominantly by air pollution. METHODS:This was a randomized, double-blind, placebo-controlled, 4-week study of subjects in Thailand with irritant rhinitis who received either FFNS 110 mcg (N=53) or placebo (N=49) once-daily. Subjects with a ?2 year history of air pollution as their predominant rhinitis trigger, negative skin test to local seasonal/perennial allergens, positive histamine skin test, and normal sinus radiograph were enrolled if they met minimum reflective total nasal symptom score (rTNSS) ?4.5 (maximum=9) and a nasal congestion score of ?2 (maximum =3). All were assessed for nasal eosinophilia at study entry and completion. Air quality was monitored throughout the study. The primary efficacy endpoint was the mean change from baseline over the treatment period in daily rTNSS, the average of the morning and evening rTNSS. The key secondary measure was the mean change from baseline over the entire treatment period in morning pre-dose instantaneous total nasal symptom score (iTNSS). RESULTS:The Air Quality Index (AQI) during the study generally did not reach unhealthy levels. Baseline daily rTNSS scores were similar between treatment groups (FFNS=6.7; placebo=6.4). The least square mean change from baseline in rTNSS was -2.17 and -2.10 for FFNS and placebo, respectively, with a difference of -0.065 (p=0.845). Gradual improvements were seen in both treatment groups for iTNSS; however, the treatment difference (-0.075) was not statistically significant (p=0.827). Additionally, there were no statistically significant differences between treatment groups for AM and PM rTNSS, individual nasal symptoms, daily reflective, AM and PM reflective and AM pre-dose instantaneous total ocular symptom scores (TOSS) or individual ocular symptom scores. Nasal cytology at baseline found more than two-thirds of subjects had <20% eosinophils. Adverse events were few and similar between groups and noted as mild in intensity. CONCLUSION:Subjects receiving FFNS had similar improvement to placebo in their rhinitis symptoms. The lack of a treatment effect may be in part due to the overall good air quality present throughout the study or an insufficient dose or duration of FFNS. The safety findings showed FFNS 110 mcg once daily to be well tolerated.

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Fexofenadine: review of safety, efficacy and unmet needs in children with allergic rhinitis

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