The Efficacy and Safety of Bilastine in the Treatment of Perennial Allergic Rhinitis in Patients with Moderate and Severe Forms of the Disease. Comparison of bilastine 20 mg with desloratadine 5 mgСергей

Медицинский совет

I. Gogunska¹  L. Romanyuk²  V. Pravdyva³  B. Bil⁴  I. Lymar⁵  S. Pukhlik⁶  S. Ryazantsev⁷  V. Lapshyn⁸  V. Koshlia⁹ 

[1] A.I. Kolomiychenko Institute of Otolaryngology of the National Academy of Medical Sciences of Ukraine;Allergology Department No. 1 -- Kiev City Clinical Hospital No. 8;Allergology and Rheumatology Department of the Municipal Institution of the Kiev Regional Clinical Hospital of the Kiev Regional Council;City Clinical Hospital No. 9;Consultation and Diagnostic Centre of the Desnyansky District;Otolaryngology Chair, Odessa National Medical University;Saint-Petersburg Research Institute of Ear, Throat, Nose, and Speech;State Institution Institute of Pediatrics, Obstetrics and Gynecology of NAMS of Ukraine;Zaporozhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine, Multidisciplinary Clinical Hospital No. 9.;

关键词: allergic rhinitis;    bilastine;    desloratadine;    itchy eyes;    watery eyes;   

DOI  :  10.21518/2079-701X-2019-20-58-67

来源: DOAJ

【 摘 要 】

Background: Bilastine is a new non-sedating H1 antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis (ARC) and urticaria in adults and children over 12 years of age. In this paper, bilastine was compared with desloratadine in the treatment of various forms of allergic rhino-conjunctivitis classified according to the ARIA recommendations.Materials and Methods: This was an international, multi-centre, open-label, prospective randomized, parallel-group, phase III study which enrolled a total of 226 patients with ARC. The diagnosis of the allergic rhino-conjunctivitis was established on the basis of nasal and non-nasal symptoms and confirmed by the skin prick test. Patients were randomized to one of the two treatment groups: bilastine 20 mg daily or desloratadine 5 mg daily.Results: The results for the primary and secondary endpoints showed a comparable reduction in TSS, NSS, and NNSS from the baseline to the end of the treatment between the treatment groups, with slightly better effects for bilastine. Additional tests carried out in the subgroup of patients with moderate / severe persistent (MSP) ARC demonstrated comparable results for the bilastine and desloratadine groups regarding the mean change in TSS from the baseline until the 28th day, except for the sneezing score, for which bilastine showed the higher response (-1.60 ± 0.60 vs. -1.39 ± 0.63), and a statistically significant difference between the treatment groups regarding AUC for TSS ( -26.07 [95% CI: -48.6, -3.53] p = 0.024), NNSS (-10.51 [95% CI:-19.42, -1.59] p = 0.021), the sneezing score (-4.79 [95% CI:-9.06, -0.51] p = 0.028) and the ocular redness score (-5.50 [95% CI: -8.91, -2.08] p = 0.02).Conclusion: In general, bilastine and desloratadine showed a comparable efficacy profile in the treatment of ARC; however, the results obtained in the subgroup of patients with moderate / severe persistent symptoms indicate that bilastine has a stronger therapeutic effect

【 授权许可】

Unknown