Efficacy of ebastine in the control of nasal congestion associated with allergic rhinitis.
Three similarly designed, multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative studies were carried out in the United States in a total of 1,881 patients to evaluate the efficacy of ebastine 20 mg (E20), ebastine 10 mg (E10), loratadine 10 mg (L10), and placebo (P), all given once daily, in controlling the symptoms of ragweed-induced rhinitis over a 4-week treatment period. Efficacy was assessed, among other means, by nasal congestion symptom scores entered by patients on diary cards in the morning and before bedtime over the previous 12-h period (reflective score, R) and at the time of recording (snapshot score, SS). Mean value of both morning and evening score changes from baseline were analyzed in each study and for each treatment. E20 was more effective than placebo in all studies, in both R and SS symptom scores (6 of 6 scores), while E10 was effective in 4 of 6 scores (2 R and 2 SS). In contrast, L10 was effective in only 1 of 6 scores (1 R). In conclusion, the comparative analysis of the results from these three trials shows that ebastine is efficacious in the reduction of nasal congestion associated with seasonal allergic rhinitis. This symptomatic effect of ebastine may be accounted for by its ability to reduce inflammatory markers, as shown in preclinical studies, in addition to its primary effect of antagonizing histamine H1 receptors.
Ratner
P
P
Sylvana Research Associates, San Antonio, Texas, USA. phratner@swbell.net
Hampel
F
F
Gispert
J
J
D000328:Adult; D031164:Ambrosia / Q000009:adverse effects; D002090:Butyrophenones / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D039563:Histamine H1 Antagonists, Non-Sedating / Q000627:therapeutic use; D006801:Humans; D017336:Loratadine / Q000627:therapeutic use; D008297:Male; D015508:Nasal Obstruction / Q000188:drug therapy* / Q000209:etiology; D010880:Piperidines / Q000008:administration & dosage / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000188:drug therapy*
D002090:Butyrophenones; D006634:Histamine H1 Antagonists; D039563:Histamine H1 Antagonists, Non-Sedating; D010880:Piperidines; D017336:Loratadine; C058249:ebastine