Efficacy and safety of bilastine vs. levocetirizine for the treatment of chronic idiopathic urticaria: A multicenter, double-blind, double-dummy, phase III, non-inferiority, randomized clinical trial
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Cited by 3 publications
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Data mining in FAERS: association of newer-generation H1-antihistamines with nervous system disorders
Background H1-antihistamines are widely used to treat symptoms depending on histamine release in a variety of conditions. However, neurological adverse events have been reported in post-marketing surveillance studies and there are limited literatures comparing the neurological disorders associated with newer-generation H1-antihistamines from real-world datasets. Aims We performed a comparative analysis of nervous system disorders and several newer-generation H1-antihistamines including: cetirizine, loratadine, levocetirizine, desloratadine and fexofenadine. Methods Disproportionality analysis was used to identify the suspected drug neurological adverse events associated with H1-antihistamines of interest via the Food and Drug Administration Adverse Event Reporting System. The proportional reporting ratio (PRR), χ 2 (chi-square) and the reporting odds ratio (ROR) with 95% confidence interval (CI) were used to estimate the association. Results AE reports of 43,815 cases from 2017 to 2021 were extracted from FAERS. The H1-antihistamines included in our study were associated with various neurological adverse events that could be classified into 12 aspects, containing 42 preferred terms. The majority of adverse event reports were concentrated at somnolence: cetirizine [ N = 1342, ROR (95%CI) = 11.8 (11.2–12.5), PRR = 10.8, χ 2 = 11755.4], levocetirizine [ N = 1276, ROR(95%CI) = 28.5 (26.7–30.3), PRR = 22.7, χ 2 = 26218.4], loratadine[ N = 516, ROR(95%CI) = 4.6 (4.2-5.0), PRR = 4.4, χ 2 = 1378.1], desloratadine [ N = 33, ROR(95%CI) = 6.1 (4.3–8.6), PRR = 5.8, χ 2 = 131.9], fexofenadine [ N = 498, ROR(95%CI) = 5.0 (4.6–5.5), PRR = 4.8, χ 2 = 1519.0]. Conclusion Neurological AEs associated with individual newer generation H1-antihistamines of interest varies a lot, whereas somnolence was the most common AE reports. Fexofenadine was highly associated with headaches. Sedative effects associated with levocetirizine and cetirizine should arouse more concern. Seizures significantly associated with levocetirizine and desloratadine were infrequently reported, further research is needed to avoid possible serious outcomes. Patients taking cetirizine probably have higher risk of dystonia and anticholinergic syndrome. Supplementary Information The online version contains supplementary material available at 10.1186/s40360-024-00822-x.
Data mining in FAERS: association of newer-generation H1-antihistamines with nervous system disorders
Background H1-antihistamines are widely used to treat symptoms depending on histamine release in a variety of conditions. However, neurological adverse events have been reported in post-marketing surveillance studies and there are limited literatures comparing the neurological disorders associated with newer-generation H1-antihistamines from real-world datasets. Aims We performed a comparative analysis of nervous system disorders and several newer-generation H1-antihistamines including: cetirizine, loratadine, levocetirizine, desloratadine and fexofenadine. Methods Disproportionality analysis was used to identify the suspected drug neurological adverse events associated with H1-antihistamines of interest via the Food and Drug Administration Adverse Event Reporting System. The proportional reporting ratio (PRR), χ 2 (chi-square) and the reporting odds ratio (ROR) with 95% confidence interval (CI) were used to estimate the association. Results AE reports of 43,815 cases from 2017 to 2021 were extracted from FAERS. The H1-antihistamines included in our study were associated with various neurological adverse events that could be classified into 12 aspects, containing 42 preferred terms. The majority of adverse event reports were concentrated at somnolence: cetirizine [ N = 1342, ROR (95%CI) = 11.8 (11.2–12.5), PRR = 10.8, χ 2 = 11755.4], levocetirizine [ N = 1276, ROR(95%CI) = 28.5 (26.7–30.3), PRR = 22.7, χ 2 = 26218.4], loratadine[ N = 516, ROR(95%CI) = 4.6 (4.2-5.0), PRR = 4.4, χ 2 = 1378.1], desloratadine [ N = 33, ROR(95%CI) = 6.1 (4.3–8.6), PRR = 5.8, χ 2 = 131.9], fexofenadine [ N = 498, ROR(95%CI) = 5.0 (4.6–5.5), PRR = 4.8, χ 2 = 1519.0]. Conclusion Neurological AEs associated with individual newer generation H1-antihistamines of interest varies a lot, whereas somnolence was the most common AE reports. Fexofenadine was highly associated with headaches. Sedative effects associated with levocetirizine and cetirizine should arouse more concern. Seizures significantly associated with levocetirizine and desloratadine were infrequently reported, further research is needed to avoid possible serious outcomes. Patients taking cetirizine probably have higher risk of dystonia and anticholinergic syndrome. Supplementary Information The online version contains supplementary material available at 10.1186/s40360-024-00822-x.
Bilastine-Loaded Transethosome Based Nanogel for the Treatment of Allergic Reactions: An In vitro Characterization
Objective: The goal of the current study was to formulate and evaluate bilastine-loaded transethosomal nanogel. Bilastine has 60% oral bioavailability, which restricts the rate of absorption and dissolution and classifies it under BCS class II drugs, which can be overcome by incorporating bilastine in transethosomal nanogel formulation in the treatment of urticaria. Method: Bilastine-loaded transethosomes were prepared using a thin film hydration method with different proportions of Tween 80 and ethanol by using a rotary evaporator and incorporated into a transethosomal gel using Carbopol 934 as a polymer by dispersion method. Results: The bilastine-loaded transethosomal formulation was optimized by using the “Box Behnken design” and evaluated for various parameters. The optimized formulation was found to be stable, as determined by the zeta potential of −27.0 mV and polydispersity index (PDI) of 0.167, and vesicle size was found to be 183nm and exhibiting the maximum entrapment efficiency of up to 80.23%. The drug content of the transethosomal gel was found to be 81.56%. The best results were obtained with a transethosomal gel prepared with 1% Carbopol 934 (TF7G2). The optimized batch showed prolonged in-vitro release of bilastine for 8hrs. Ex vivo skin permeation studies showed 76.23 ± 2.63% permeation in comparison with plain gel. Conclusion: Transethosomal nanogel batches were optimized based on drug content, viscosity, uniformity of drug content, zeta potential, spreadability, pH, drug release, and stability testing, exhibiting good results. The results of this investigation showed that the transethosomal nanogel loaded with bilastine might be used to improve bilastine delivery through the skin with greater bioavailability. result: The Bilastine loaded transethosomal formulation was found to be stable, which was confirmed by the zeta potential of −27.0 mV and polydispersity index (PDI) of 0.167, vesicle size was found to be 183nm, exhibiting the maximum entrapment efficiency of up to 80.23%. It was determined that 81.56% of the transethosomal gel contained drug. The best results were obtained with a transethosomal gel which was prepared with 1
Bilastine Reimagined: A Comprehensive Exploration of Pruritus Management With a Novel Antihistamine
Managing pruritic conditions is essential due to their significant impact on patients' quality of life. Chronic urticaria (CU), characterized by persistent itching and hives, severely affects daily activities and sleep. CU includes chronic inducible urticaria and chronic spontaneous urticaria, with the latter lacking identifiable triggers, making treatment especially challenging. CU is a condition that occurs across all age groups, with a higher prevalence among young adults and middle-aged women. Current antihistamine treatments include first-generation antihistamines, which are associated with sedation, and second-generation antihistamines such as cetirizine and fexofenadine, which cause less sedation but have varying efficacy and safety profiles. Bilastine, a novel second-generation H1-antihistamine, offers advantages due to its potent antihistaminic activity, rapid onset of action, and minimal sedation. This narrative review thoroughly synthesizes the evidence for the efficacy and safety of bilastine in treating CU and other pruritic conditions. By analyzing clinical trials, real-world evidence, and comparative studies, this review aims to provide a comprehensive understanding of the role of bilastine in managing pruritic conditions, emphasizing its pharmacokinetic properties, clinical efficacy, and safety profile compared to other antihistamines.
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