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,1,2 Hyung Gu Kim,3 Jeong-Whun Kim,1 Jin Kook Kim,4 Young Hyo Kim,5 Soo Whan Kim,6 Hyo Yeol Kim,7 Dae Woo Kim,8 Sung Wan Kim,9 Chang-Hoon Kim,10 Chae-Seo Rhee2
1 Department of Otorhinolaryngology-Head & Neck Surgery, Seoul National University Bundang Hospital, Seongnam, Korea
2 Department of Otorhinolaryngology-Head & Neck Surgery, Seoul National University Hospital, Seoul, Korea
3 Department of Otorhinolaryngology-Head & Neck Surgery, Hanyang University Guri Hospital, Guri, Korea
4 Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, Konkuk University, Seoul, Korea
5 Department of Otorhinolaryngology, Inha University, Incheon, Korea
6 Department of Otolaryngology–Head and Neck Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
7 Department of Otorhinolaryngology, Samsung Medical Center, Seoul, Korea
8 Department of Otorhinolaryngology, Seoul National University Boramae Medical Center, Seoul, Korea
9 Department of Otorhinolaryngology, Kyunghee University Hospital, Seoul, Korea
10 Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea
Abstract
Background: The efficacy of rupatadine for the treatment of AR has been confirmed in numerous clinical studies, however there are very few studies on asian patients.
Objectives: To assess the safety and efficacy of rupatadine fumarate in the treatment of Korean perennial allergic rhinitis (PAR) patients.
Methods: A multicenter, double-blind, randomized, placebo-controlled, comparative study of rupatadine fumarate and bepotastine besilate was conducted. Each group was administered rupatadine, bepotastine or placebo for 4 weeks. Primary parameters for efficacy included morning and evening symptom reduction from baseline at 4 weeks. Treatment safety and tolerability were evaluated according to a self-reported incidence and type of adverse events at each follow up visit.
Results: Rupatadine showed a significant reduction in symptoms at morning and evening evaluations, in both 5TSS (-5.69, P < 0.0006) and 4NTSS (-4.74, P < 0.0015) compared to placebo. There was a significant reduction from baseline for 5TSS (-65.4%, P = 0.002) and 4NTSS (-63.7%, P = 0.003) with rupatadine compared with placebo. At evening evaluations, there were significant reductions of 5TSS (-63.2%, P = 0.009) and 4NTSS (-61.6%, P = 0.013) for the rupatadine group. Compared with bepotastine, rupatadine showed greater reduction in the morning symptoms at 4 weeks. When individual symptoms were assessed with 12-hour reflective mean daily symptom score, rupatadine showed better efficacy than placebo in sneezing (P = 0.016) and rhinorrhea (P = 0.097). The rate of adverse events showed no statistical significance.
Conclusion: Rupatadine is a safe and effective treatment option for Korean PAR patients and possibly a better choice over bepotastine for controlling morning symptom.
Key words: Perennial Allergic rhinitis, Platelet-activating factor, Histamine antagonists, TNSS, Randomized controlled trial, Clinical trial