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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
Author(s) -
Hampel Frank,
Gillen Michael,
Rohatagi Shashank S.,
Lim Janet,
Georges George
Publication year - 2002
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/009127002237990
Subject(s) - medicine , placebo , adverse effect , double blind , population , anesthesia , alternative medicine , environmental health , pathology
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 ≥ 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 ofpatients 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.