Abstract
This 12-week survey was a prospective, multicenter, post-marketing surveillance study conducted to evaluate the safety and efficacy of rupatadine fumarate (hereinafter referred to as rupatadine) in patients with allergic rhinitis in the real-world setting.
The safety analysis set included 1,332 patients; 58.1% of the subjects were female, 0.1% were children (<12 years old), 10.7% were adolescents (12–17 years old), and 21.5% were elderly (≥65 years old). The incidence of adverse drug reactions (ADRs) was 4.73%, and the incidence of somnolence, an adverse effect of special interest as well as the most common ADR in this survey, was 3.98%. The incidence of ADRs was 4.90% in adolescents, 4.99% in non-elderly subjects (18–64 years old), and 3.85% in elderly, with no statistically significant differences among these age groups. No ADRs were observed in 9 patients with liver dysfunction and 5 patients with renal dysfunction. The efficacy analysis set included 1,219 patients. Of these, 1,186 patients were analyzed for the response rate (great/moderate/mild improvement) during the observation period. The response rate was 91.5%, and no significant differences in the response rate were observed by age (adolescents, non-elderly and elderly) or presence/absence of liver/renal dysfunction. Improvements in the symptom scores for all three symptons of allergic rhinitis (paroxysmal sneezing, rhinorrhea, and nasal congestion) were observed after one week of treatment with rupatadine.
In conclusion, there were no new safety and efficacy concerns in the real-world setting as compared with reports from previous clinical trials.
