Setastine Hydrochloride

In order to assess the effects of Loderix (setastine) on the EEG ten healthy male volunteers were investigated in double-blind, placebo-controlled, cross-over arrangement. In addition to the test compound (Loderix) volunteers were treated with vehicle and with two referent drugs (terfenadine, Teldane, and chloropyramine HCl, Suprastin) possessing sedative effects of very different degrees. The different effects of the referent drugs on the central nervous system (CNS) were precisely indicated by the posterior alpha/theta ratio in the EEG. This marker parameter was affected by Loderix in the same direction as by Teldane and in the opposite direction as compared to Suprastin. In addition, Loderix increased the beta frequency range in the median areas of both hemispheres, moreover, it increased the total EEG power. The latter changes raise the question if Loderix has an "own" action on the EEG. (The observed "own" effect could not even be brought into connection with decrease of the vigilance level). The results strengthen the view that the action of Loderix on the EEG is similar to that of induced by Teldane, a drug very favourable in respect of the sedative side effects. Moreover, the drug did not affect the EEG power spectra in a direction that referred to sedative action. The spectral parameters in the "pharmaco" EEG recordings seem to be useful in the objective definition of the central (psychotropic) side-effects of drugs. This is a methodical achievement of the present study.

The action and side-effects of Loderix (EGIS) were examined in comparison with Hismanal (Janssen) containing the non-sedative H1-receptor antagonist astemizole, by double-blind, cross-over, self-controlled method. On the basis of the changes observed in response to the two drugs in the symptoms of rhinoconjunctivitis and asthma of 21 patients suffering from pollenosis Loderix proved to be of the same value as Hismanal considering both clinical effectivity and side-effects.