Comparison of once-daily ebastine 20 mg, ebastine 10 mg, loratadine 10 mg, and placebo in the treatment of seasonal allergic rhinitis. The Ebastine Study Group.
BACKGROUND
Ebastine and loratadine are 2 nonsedating second-generation H(1) antihistamines with once-daily dosing.


OBJECTIVE
We compared the efficacy and safety of ebastine 20 mg and 10 mg, loratadine 10 mg, and placebo administered once daily for 4 weeks in controlling the symptoms of seasonal allergic rhinitis (SAR).


METHODS
In a double-blind, placebo-controlled, randomized, parallel-group study, 565 patients with ragweed SAR, ages 12 to 70 years, received either ebastine 20 mg, ebastine 10 mg, loratadine 10 mg, or placebo once daily for 4 weeks. Patients recorded morning and evening reflective scores (past 12 hours) as well as snapshot scores (at time of recording) for nasal discharge, congestion, sneezing, itching, and total eye symptoms. Total symptom score (TSS) is the sum of these 5 scores.


RESULTS
Ebastine 20 mg produced significantly greater (P <.05) reductions from baseline compared with loratadine 10 mg over the entire treatment period in the mean daily reflective (42.5% vs 36.3%) and mean morning snapshot (40.3% vs 31.3%) TSS. The overall improvement in daily reflective and morning snapshot TSS was comparable between ebastine 10 mg and loratadine 10 mg and significantly better than placebo (P <.05). The total percent of patients with adverse events was similar among all 4 treatment groups (P =.78).


CONCLUSIONS
Ebastine 20 mg given once daily was significantly superior to loratadine 10 mg given once daily at improving the rhinitis total symptom score throughout the day and at awakening over a 4-week period. Ebastine 20 mg and 10 mg doses were both efficacious and well tolerated in the treatment of SAR.
Ratner
P H
PH
Sylvana Research, San Antonio, TX, USA.
Lim
J C
JC
Georges
G C
GC
D000293:Adolescent; D000328:Adult; D000368:Aged; D002090:Butyrophenones / Q000008:administration & dosage* / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage* / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*
D002090:Butyrophenones; D006634:Histamine H1 Antagonists; D010880:Piperidines; D017336:Loratadine; C058249:ebastine