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This randomized, placebo-controlled, double-blind, comparative study was carried out to examine the efficacy and safety of rupatadine in 330 patients diagnosed with perennial allergic rhinitis (PAR).
Rupatadine fumarate is an effective and safe therapeutic
choice for the management of perennial allergic rhinitis patients. Also,
rupatadine showed superiority over bepotastine besilate in controlling morning
symptoms.
This randomized, placebo-controlled, double-blind,
comparative study was carried out to examine the efficacy and safety of
rupatadine in 330 patients diagnosed with perennial allergic rhinitis (PAR).
In this multicenter study, participants were randomized to
the rupatadine group (n=108), bepotastine group (reference drug, n=111) and
placebo group (n=111) for four weeks. A decline in the morning and evening
symptoms from baseline after four weeks of therapy was the major efficacy
endpoint. In addition, the safety and tolerability of therapy were assessed as
per a self-reported incidence and type of side effects at each visit.
Rupatadine demonstrated a considerable decline in symptoms at morning and evening evaluations, in both total symptom score (5TSS, -5.69) and four nasal total symptom scale (4NTSS, -4.74) in comparison with placebo.
In the morning assessments, there was a remarkable drop from baseline for 5TSS (-65.4%) and 4NTSS (-63.7%) with rupatadine in comparison with placebo. A substantial drop of 5TSS (-63.2%) and 4NTSS (-61.6%) in the evening assessments was noted for the rupatadine recipients.
In comparison with bepotastine, rupatadine illustrated more decrease in the
morning symptoms at four weeks. When individual symptoms were evaluated with a
12-hour reflective mean daily symptom score, rupatadine displayed better
efficacy compared to placebo in rhinorrhea and sneezing. Regarding safety, no
statistically significant rate of adverse events was reported.
In patients with PAR, rupatadine
led to a greater decline in the severity of ocular and nasal symptoms than
placebo. It is an effective and safe pharmacological option and maybe a better
choice over bepotastine for managing morning symptoms.
The Asian Pacific Journal of Allergy and Immunology
Efficacy and safety of rupatadine fumarate in the treatment of perennial allergic rhinitis: A multicenter, double-blinded, randomized, placebo-controlled, bridging study in Koreans
Tae-Bin Won et al.
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