Bilastine Safety Established via a High-speed Simulator Driving Test in Drivers who Need Antihistamines


eMediNexus    30 December 2022

Bilastine, a highly selective, nonsedating antihistamine, is indicated for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. Evidence indicates that bilastine interferes neither with driving ability nor with flying-related performance. However, the effect of bilastine on driving ability in extreme conditions remains unclear. The present study analyzed the effect of 7 days of treatment with 20 mg bilastine in patients with allergic rhinitis and/or chronic urticaria on psychophysical performance assessed by the Formula One (F1) high-speed simulator-driving test.


It enrolled 18 patients affected by allergic rhinitis and/or chronic urticaria who could perform a preliminary driving test on an F1 simulator (V-1). First, the patients underwent screening visits to assess their eligibility (V0). Visit 1 (V1) commenced at the end of the placebo but before bilastine treatment, and Visit 2 (V2) commenced at the end of bilastine treatment. The study looked for the ability of the patient to maintain the vehicle in a central position at different speeds (50, 150 and 250 km/h).


The study found:


  • The good safety profile of bilastine, which was well tolerated in terms of adverse events, laboratory parameters and vital signs.
  • No negative effect of bilastine on the ability to maintain the requested path, a constant speed, and attention and reactivity levels, even in extreme driving conditions.


This pioneering study in patients with allergic rhinitis and/or chronic urticaria using an F1-high speed simulator-driving test evaluating subjects′ performance under bilastine treatment has demonstrated a good safety profile of its use even in drivers who need to be constantly alert.


Source: Demonte A, Guanti MB, Liberati S, et al. Bilastine safety in drivers who need antihistamines: new evidence from high-speed simulator driving test on allergic patients. Eur Rev Med Pharmacol Sci. 2018;22(3):820-8. 

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