[Visual evoked potentials in the in evaluation of the safety profile of levocetirizine].

UNLABELLED: Because human histamine H1 receptors were visualized at different brain levels, we evaluated the effects of levocetirizine (LCZ) on the visual evoked potentials (VEP).

MATERIAL AND METHOD: Eighteen volunteer subjects were included in a placebo-controlled study, VEP recordings (pattern-reversal technique) were performed at baseline and 240 min. post-medication, and the N75-P100-N135 complex parameters (latency, duration, amplitude and surface of the components) were measured in the leads FzOL5, FzOz and FzOR5.

RESULTS: LCZ 5 mg p.o. induced no statistically significant changes, neither in the mean values of all P100 parameters, nor in the mean latency of N75 and N135 components. No unilateral or bilateral alterations of VEP parameters were detected, suggesting that LCZ has no influence on the functional integrity of visual sensorial pathway.

CONCLUSION: Our study may initiate a novel approach in the neurological safety profile evaluation of new H, antihistamines using VEP, with the advantage of no radiological exposure.