Rupatadine 10 mg and ebastine 10 mg in seasonal allergic rhinitis: a comparison study.
BACKGROUND
The aim of this study is to establish the efficacy and safety of rupatadine vs ebastine and placebo in the treatment of seasonal allergic rhinitis (SAR). Rupatadine is a new second generation H(1)-antihistamine with once-daily dosing that may provide better control of symptoms than the currently used H(1)-receptor blockers because of its dual pharmacological profile (anti-PAF and anti-H(1)).


METHODS
In a multicentre study, 250 patients with SAR were included in a double-blind, randomized, parallel-group and placebo-controlled study. Patients received either rupatadine 10 mg, ebastine 10 mg or placebo once daily for 2 weeks. The main efficacy outcome was based on the patient's record of severity of nasal symptoms (sneezing, nasal itching, runny nose and nasal obstruction) and nonnasal symptoms (conjunctival itching, tearing and pharyngeal itching). The daily total symptom score (DTSS) was the mean of the DSS recorded for each of the seven symptoms assessed, and the mean DTSS (mDTSS) was the mean of the DTSS values for each study day.


RESULTS
Significant differences in mDTSS were detected between rupatadine and placebo (33% lower for rupatadine group; P = 0.005) after 2 weeks of treatment. The TSS for rupatadine were 22% lower than for ebastine, although the differences were not statistically significant. No serious adverse events were reported during the study period.


CONCLUSIONS
Rupatadine 10 mg once daily was clearly superior to placebo in alleviating the symptoms of SAR over a 2-week period. In comparison with ebastine, rupatadine shows a trend towards a better profile as regard several secondary efficacy variables.
Guadaño
E M
EM
Hospital Sant Pere Claver, Barcelona, Spain.
Serra-Batlles
J
J
Meseguer
J
J
Castillo
J A
JA
De Molina
M
M
Valero
A
A
Picado
C
C
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002090:Butyrophenones / Q000009:adverse effects / Q000627:therapeutic use*; D003533:Cyproheptadine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D002090:Butyrophenones; D006634:Histamine H1 Antagonists; D010880:Piperidines; C103639:rupatadine; D003533:Cyproheptadine; C058249:ebastine