Efficacy and safety of bilastine in Japanese patients with chronic spontaneous urticaria: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II/III study
| Autor: | Akiko Yagami, Akihiro Saito, Masutaka Furue, Michihiro Hide, Michinori Togawa |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male lcsh:Immunologic diseases. Allergy Histamine H1 Antagonists Non-Sedating medicine.medical_specialty Adolescent Urticaria Placebo Total symptom score Double blind Young Adult 030207 dermatology & venereal diseases 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Piperidines Internal medicine medicine Humans Immunology and Allergy DLQI Trial registration Aged Early onset Bilastine business.industry General Medicine Middle Aged Chronic spontaneous urticaria Rash Surgery H1-antihistamine Phenotype Treatment Outcome 030228 respiratory system chemistry Chronic Disease Quality of Life Benzimidazoles Female Once daily medicine.symptom business lcsh:RC581-607 |
| Zdroj: | Allergology International, Vol 66, Iss 2, Pp 317-325 (2017) |
| ISSN: | 1323-8930 |
| Popis: | Background: Bilastine, a novel non-sedating second-generation H1-antihistamine, has been widely used in the treatment of allergic rhinoconjunctivitis and urticaria with a recommended dose of 20 mg once daily in most European countries since 2010. We evaluated its efficacy and safety in Japanese patients with chronic spontaneous urticaria (CSU). Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled phase II/III study (trial registration No. JapicCTI-142574). Patients (age, 18–74 years) were randomly assigned to receive bilastine 20 mg, 10 mg or placebo once daily for 2 weeks. The primary efficacy endpoint was the change from baseline (Day −3 to 0) in total symptom score (TSS) at 2 weeks (Day 8–14), consisting of the itch and rash scores. Results: A total of 304 patients were randomly allocated to bilastine 20 mg (101 patients), bilastine 10 mg (100 patients), and placebo (103 patients). The changes in TSS at 2 weeks were significantly decreased by bilastine 20 mg than did placebo (p |
| Databáze: | OpenAIRE |
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