A study comparing the inhibitory effects of single and repeated oral doses of ebastine and fexofenadine against histamine-induced skin reactivity

M. J. Barbanoj, R. M. Antonijoan, C. García-Gea, A. Morte, I. Gich, J. Gispert, E. Garcia, R. Esbrí, X. Luria

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15 Citations (Scopus)

Abstract

Objective: The aim of this double-blind, randomized, crossover, placebo-controlled clinical trial was to compare the inhibition of the histamine-induced skin reaction induced by ebastine 20 mg with respect to that induced by fexofenadine 120 mg or placebo. Methods: Eighteen volunteers (10 males, 8 females) received the three treatments once daily for 5 days, with a mean 7-day washout period between treatments. Intradermal tests, using 0.05 ml from a solution containing 100 μg/ml of histamine, were performed at baseline and at 1, 1.5, 2, 3, 10 and 24 h after a single dose and repeated 5-day dose, and in addition after 34, 48, 58 and 72 h after repeated 5-day dose. Results: After 24 h of acute administration, ebastine 20 mg was significantly more effective than fexofenadine 120 mg in reducing the wheal and flare induced by histamine challenge (p < 0.001). Although fexofenadine 120 mg had the shortest onset of action (1.5 vs. 3 h in ebastine 20 mg), the duration of its antihistamine effect was the shortest (24 vs. 58 h in ebastine 20 mg) and wheal reduction after 24 h was not significantly different from placebo. The overall effect after single and repeated 5-day dose, expressed as the AUC of reduction of wheal and flare area (%/h), showed the following order of magnitude: ebastine 20 mg > fexofenadine 120 mg > placebo. No significant differences in the incidence of adverse events were found between the three treatments. Conclusions: The present results clearly show a superior and long-acting effect of ebastine 20 mg compared with fexofenadine 120 mg on the skin response to histamine 24 h after dosing. Copyright © 2003 S. Karger AG, Basel.
Original languageEnglish
Pages (from-to)263-267
JournalInternational Archives of Allergy and Immunology
Volume132
Issue number3
DOIs
Publication statusPublished - 16 Dec 2003

Keywords

  • Ebastine antihistamine
  • Ebastine/fexofenadine, pharmacodynamic effects
  • Fexofenadine antihistamine
  • Histamine-induced skin reactivity
  • Wheal and flare reactions

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