Rupatadine is a second-generation antihistamine indicated for the treatment of AR and urticaria. The aim and strength of this study was to provide information regarding the safety and efficacy of rupatadine in very young children (two-five years) suffering from AR. There is very little published research on children diagnosed according with ARIA classification and treated with second-generation anti-H1 compounds. Most of the available paediatric literature with antihistamines are published with seasonal or perennial AR in older children (over six years old).
Safety assessments were collected during the study including spontaneous adverse events, vital signs, and electrocardiogram (QTc interval). Additionally, evaluations of Total Five Symptoms Score (T5SS, including: nasal congestion; sneezing; rhinorrhoea; itchy nose, mouth, throat, and/or ears; and itchy, watery, and red eyes) were analysed. Symptoms were evaluated by parents/legal guardian before and after four weeks of rupatadine administration, dosed according to body weight.
A total of 44 children received the study treatment. Only 15 adverse events were reported. All of them were of mild intensity and considered not related to the study treatment.
From a maximum score value of 15, T5SS values at day 14 (6.35) and day 28 (5.42) were both statistically significant different (p<0.001) from the baseline T5SS value (mean 8.65), with a reduction of 26% and 37%, respectively. All individual symptoms, including nasal congestion, also showed a decrease from baseline at both 14 and 28 days.
The percentage of improvement in symptoms after four weeks of treatment (37%) is close to a major pivotal trial using the same endpoint with a placebo-controlled design, and this similarity gives external validation of the present data in very young children. In addition, all symptoms improved individually, at least an average 20% of improvement, even for nasal congestion. The improvement obtained in T5SS after 28 days was somewhat higher than after 14 days (mean value 26%), showing that there was no tachyphylaxis.
This study showed that once-daily rupatadine oral solution was found to be safe and was correlated with an improvement of AR symptoms in young children (two-five years old) with a magnitude similar to that observed in older ones (6-11 years old).
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