A double-blind, placebo-controlled study of the efficacy and safety of ebastine 20 mg once daily given with and without food in the treatment of seasonal allergic rhinitis.

Abstract

The efficacy and safety of ebastine 20 mg once daily given with and without food were compared in patients ages 12 to 70 years with seasonal allergic rhinitis (SAR) caused by mountain cedar allergen. This double-blind, placebo-controlled study was conducted at six centers in Texas. Efficacy and safety analyses were performed on the intent-to-treat population, which comprised 652 patients; 540 patients completed the study. Following 2 weeks' treatment, no significant differences (p > or = 0.91) were found between the ebastine with and without food groups in the percentage change from baseline of daily "reflective" total rhinitis symptom scores (i.e., patients' assessment of severity over the previous 12 h), but both ebastine groups exhibited significantly greater reductions versus patients receiving placebo (p < 0.0001). There were also no significant differences in the percentages of patients experiencing adverse events between the ebastine with and without food groups. Mean steady-state plasma concentrations of ebastine and its active metabolite carebastine were, respectively, 5.5% (ns) and 15.1% (p < 0.05) higher when ebastine was given with food versus its administration without food. Overall, these results indicate that in clinical practice, ebastine does not need to be administered with reference to food.

• Authors: Hampel Frank Jr, Michael Gillen, Shashank S Rohatagi, Janet Lim, George George, Ebastine Study Group
• Journal: Journal of clinical pharmacology (J Clin Pharmacol) Vol. 42 Issue 10 Pg. 1097-104 (Oct 2002) ISSN: 0091-2700 [Print] England
• PMID: 12362923 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Butyrophenones
• Histamine H1 Antagonists
• Piperidines
• carebastine
• ebastine

Topics

• Adolescent
• Adult
• Aged
• Butyrophenones (blood, pharmacokinetics, pharmacology, therapeutic use)
• Child
• Double-Blind Method
• Female
• Food-Drug Interactions
• Histamine H1 Antagonists (pharmacokinetics, pharmacology, therapeutic use)
• Humans
• Male
• Middle Aged
• Piperidines (blood, pharmacokinetics, pharmacology, therapeutic use)
• Rhinitis, Allergic, Seasonal (blood, drug therapy)
• Severity of Illness Index
• Treatment Outcome