Critical appraisal of bilastine for the treatment of allergic rhinoconjunctivitis and urticaria

Sádaba, Belén; Azanza, J. R.; Gomez-Guiu, Almundena; Rodil, Raquel

doi:10.2147/tcrm.s16079

Cited by 15 publications

(26 citation statements)

References 31 publications

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“…These results confirm that, in children, bilastine 10 mg has a safety and tolerability profile similar to that of placebo [5]. In adults, bilastine at the recommended dose of 20 mg has an excellent safety profile, with good tolerability and no sedative effects or cardiotoxicity [2,[7][8][9].…”

Section: Discussionsupporting

confidence: 70%

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Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Rodríguez¹,

Vozmediano²,

García-Bea

et al. 2020

Eur J Pediatr

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Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years. Pharmacokinetic data for children aged 6-11 years were extracted post hoc from a study in which children (2-11 years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10 mg/day). Maximum plasma concentration (C max) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). Safety data for children aged 6-11 years were extracted post hoc from a phase III randomized controlled trial of children (2-11 years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10 mg or placebo for 12 weeks. Exposure and C max values were similar for children (6-11 years) and adults: median pediatric/adult ratios for AUC 0-24 and C max were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo. Conclusion: Pharmacokinetic and safety analyses in children aged 6-11 years support the suitability of the pediatric dose of bilastine 10 mg and confirm that the safety profiles of bilastine and placebo are similar. What is Known: • Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults (20 mg/day) and children aged ≥ 6 years (10 mg/day). • An ontogenic model based on adult data and pharmacokinetic/pharmacodynamic simulations supported the selection of a bilastine dose of 10 mg/day in children aged 2-11 years. Bilastine 10 mg/day was shown to have a safety profile similar to that of placebo in a large phase III randomized clinical trial in children aged 2-11 years. What is New: • As bilastine is approved in Europe for children aged ≥6 years, the current study reports the results of two post hoc analyses of pharmacokinetic and safety data in children aged 6-11 years. • Analysis of pharmacokinetic and safety data in children aged 6-11 years supports the suitability of the pediatric dose of bilastine 10 mg and confirms that its safety profile is similar to that of placebo.

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Section: Discussionsupporting

confidence: 70%

“…Recently, bilastine has also been approved in Mexico for children aged ≥ 2 years. The efficacy of bilastine is similar to that of other second-generation oral H 1 -antihistamines [7][8][9].…”

Section: Introductionmentioning

confidence: 58%

Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Rodríguez¹,

Vozmediano²,

García-Bea

et al. 2020

Eur J Pediatr

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“…Bilastine epitomizes the evolution of research on antihistamines concerning both efficacy and safety [ 40 ]. In AR treatment, its efficacy has been documented in several large controlled clinical trials [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

Bilastine: new insight into antihistamine treatment

et al. 2015

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Bilastine is a new second generation H1-antihistamine recently approved for the symptomatic treatment of allergic rhinitis (AR) and chronic urticaria (CU). Bilastine epitomizes the evolution of research on antihistamines concerning both efficacy and safety. In AR treatment, a number of large controlled clinical trials documented its efficacy, as assessed by improvement of all nasal and ocular symptoms and quality of life. These outcomes show that bilastine meets current EAACI/ARIA criteria for medications used in the treatment of AR. Also in CU, the review of the literature indicates that once-daily treatment with bilastine 20 mg was effective in managing symptoms and improving patient’s quality of life. Concerning safety and tolerability, the profile of bilastine is very similar to placebo and in particular the adverse effects on central nervous system are insignificant. The balance of efficacy and safety of bilastine is particularly helpful when dosages higher than standard are needed to control the symptoms, as frequently occurs in patients with urticaria, in whom antihistamines doses up to four times the standard dose may be administered.

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“…Since it is common for parents to mix the medication with food or beverages35 to improve palatability, it is beneficial to understand the compatibility of different medicine formats with food and beverages. Food–drug interactions are also important to consider, since certain antihistamines such as fexofenadine37 and bilastine38 interact with grapefruit juice or any acidic fruit juice,39 and this decreases drug bioavailability.…”

Section: Patient Profilesmentioning

confidence: 99%

<p>Using Patient Profiles To Guide The Choice Of Antihistamines In The Primary Care Setting In Malaysia: Expert Consensus And Recommendations</p>

Abdullah¹,

Latiff²,

Woo³

et al. 2019

TCRM

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H1-antihistamines are recognized to be effective for conditions such as allergic rhinitis and chronic spontaneous urticaria. However, management of such conditions in the real-world primary care setting may be challenging due to diverse patient-specific considerations, the wide range of antihistamines available, choice of other treatment modalities, and the complexity of interpreting specialist treatment algorithms. Despite regular updates to international guidelines, regional/national surveys of healthcare professionals show a clear gap between guidelines and real-world practice, particularly at the primary care level. This article thus presents the consensus opinion of experts from relevant specialties in Malaysia – allergology, pediatrics, otorhinolaryngology, and dermtology – on harmonizing the use and choice of antihistamines in primary care. Patient profiling is recommended as a tool to guide primary care practitioners in prescribing the appropriate antihistamine for each patient. Patient profiling is a three-step approach that involves 1) identifying the individual’s needs; 2) reviewing patient-specific considerations; and 3) monitoring treatment response and referral to specialists in more severe or difficult-to-treat cases. Concurrently, guidelct 3ines should be reviewed and updated periodically to include recommendations that are easily actionable for primary care practitioners.

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Critical appraisal of bilastine for the treatment of allergic rhinoconjunctivitis and urticaria

Cited by 15 publications

References 31 publications

Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria

Bilastine: new insight into antihistamine treatment

<p>Using Patient Profiles To Guide The Choice Of Antihistamines In The Primary Care Setting In Malaysia: Expert Consensus And Recommendations</p>

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