- Bilastine is a novel, oral, non-sedating antihistamine drug, with a selective affinity for histamine H1-receptors, approved for the symptomatic treatment of allergic rhinoconjunctivitis - seasonal and perennial - and idiopathic urticaria.
- Efficacy and safety of bilastine for the treatment of seasonal allergic rhinitis have been assessed and compared in two randomised, double-blind clinical trials. The first trial (N=721) compared bilastine vs desloratadine and placebo, and the second trial (N=683) vs cetirizine and placebo. At both, the main efficacy outcome was the area under the curve of the reflective total nasal and non-nasal symptoms score recorded by the patient, twice a day (from baseline to the end of the treatment). The European Medicines Agency does not, nevertheless, consider this outcome and defines it as secondary outcome. Efficacy and safety of bilastine vs levocetirizine and placebo for the treatment of chronic idiopathic urticaria have been evaluated in a randomised, double-blind clinical trial.
- Bilastine was not different to desloratadine and cetirizine in relieving symptoms of seasonal allergic rhinitis. There are no comparative studies available for perennial allergic rhinitis. In the treatment of chronic idiopathic urticaria, comparison of bilastine to levocetorizine indicated both compounds to be equally efficacious in reducing pruritus symptoms and the number of wheals, but less effective regarding maximum size of wheals.
- Bilastine is well tolerated and has a safety profile similar to other compared antihistamines, although it does show more drug interactions. The most frequently reported adverse events, throughout the studies, were headache, somnolence and fatigue.
- Dose administration is delicate compared to other antihistamines since it has to be taken an hour before or two hours after the intake of food or fruit juices to avoid reducing bioavailability of the drug.
- Bilastine adds nothing new to the treatment of the authorised indications since it has not shown to be superior – in efficacy or safety - to the drugs it has been compared to. In addition, it has the disadvantage of the dosage regimen and also a higher cost than other previously commercialised antihistamines with larger experience of use available, such is the case of loratadine and cetirizine.