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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:Background: Allergic rhinitis is prevalent among children and can cause nasal itching, fatigue, and even hinder growth and development. The main discomfort symptom of allergic rhinitis is nasal itching. Clinical reports suggest that Chinese herbal medicine (CHM) is effective in allergy rhinitis treatment. Therefore, we evaluate the clinical efficacy of Chinese herbal medicine in treating nasal itching caused by allergic rhinitis in children. Methods: Nine databases, including PubMed, Embase, The Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wan Fang Data, CQVIP, Chinese Biological Medicine, and ClinicalTrials.gov, were systematically searched from their inception until March 2023. Randomized controlled trials (RCTs) comparing the efficacy of Chinese herbal medicine, either alone or in combination with Western medicine, to Western medicine treatment or placebo intervention for treating allergic rhinitis in children were eligible for inclusion. The effectiveness of Chinese herbal medicines for nasal itching was mainly evaluated. The Risk of Bias tool 2.0 assessed the risk of bias. Statistical analysis using RevMan 5.3 and Stata/SE 12. The quality of evidence was evaluated by GRADEpro 3.6. Risk ratios (RR) with corresponding 95% confidence intervals (CI) were utilized to evaluate and present dichotomous data, while mean difference (MD) and standardized mean difference (SMD) were employed for continuous data. A fixed-effects model was applied in cases where the data exhibited homogeneity (p > 0.1, I2 < 50%), whereas a random-effects model was utilized for heterogeneous data. Statistical significance was determined by a p-value <0.05. This study was conducted by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and its review protocol was registered on the International Platform for Registered Systematic Reviews and Meta-Analysis Programs (INPLASY202340076). Results: The review incorporated 23 studies. The meta-analysis indicated that herbal medicine was significantly related to the reduction of nasal itching (MD = -0.59, 95%CI: -0.94-0.24) and the increase of interleukin 10 level (SMD = 1.47, 95% CI: 0.90-2.05). Compared to Western medicine, the combining herbs and Western medicine showed better efficacy in relieving nasal itching, inhibiting immunoglobulin E, interleukin 4 and 33, enhancing interleukin 10, improving therapeutic efficiency, and reducing recurrent. Oral herbal medicine was more effective in treating nasal itching (MD = -0.45, 95% CI: -0.62-0.29). Combining oral and external herbal medicines was more efficient in treating nasal itching (MD = -0.44, 95% CI: -0.54-0.33), inhibiting immunoglobulin E, interleukin 4 (SMD = -0.87, 95% CI: -1.24-0.50) and 33 (SMD = -1.16, 95% CI: -1.54-0.77), and improving therapeutic efficiency. External herbal medicine did not show differences compared to Western medicines. Regarding safety, herbal medicine alone exhibited fewer adverse events than Western medicine; combining herbal and Western medicine showed no significant variation in adverse event incidence. Conclusion: Chinese herbal medicine (CHM) holds great potential in alleviating symptoms, modulating immune factors levels, and reducing relapse in pediatric rhinitis. Meanwhile, CHM is relatively safe. However, the efficacy and safety of CHM in treating pediatric rhinitis still need to be confirmed due to the inclusion of studies with low methodological quality, small sample sizes, and potential heterogeneity. More high-quality research is necessary to provide reliable evidence for the clinical application of CHM. Systematic Review Registration: INPLASY.com, identifier INPLASY202340076.

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

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