A Comparative, Three-Arm, Randomized Clinical Trial to Evaluate the Effectiveness and Tolerability of Bilastine vs Fexofenadine vs Levocetirizine at the Standard Dose and Bilastine vs Fexofenadine at Higher Than the Standard Dose (Up-Dosing) vs Levocetirizine and Hydroxyzine (in Combination) in Patients with Chronic Spontaneous Urticaria
Abstract
Bela Shah,1 Dhiraj Dhoot,2 Ankita Choudhary,1 Neha Jangid,1 Deval Mistry,1 Shikha Shah,1 Shruti Kamat,1 Hanmant Barkate3 1Department of Dermatology, Venereology and Leprosy, B.J.Medical College, Civil Hospital, Ahmedabad, India; 2DGM, Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, India; 3Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, IndiaCorrespondence: Dhiraj Dhoot, DGM, Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, 400099, India, Tel +91 9619811219, Email [email protected]: Though second-generation antihistamines (SGAH) are first-line drugs in chronic spontaneous urticaria (CSU), 50% of patients do not respond to them. In such patients, guidelines recommend either up-dosing of SGAH or combination of different antihistamines. However, the studies comparing these treatment regimens are limited.Methods: In this comparative, three-arm study, CSU patients were randomized to receive standard dose of either bilastine, fexofenadine, or levocetirizine for 2 weeks. After 2 weeks of treatment, non-responders received double dose of either bilastine or fexofenadine, while hydroxyzine 25 mg once daily was added in the levocetirizine group. Patients were primarily evaluated for improvement in CSU, quality of life, and somnolence.Results: A total of 110 patients with CSU were recruited. At the end of 4 weeks, 33/39, 26/35, and 22/36 patients in the bilastine, fexofenadine,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 110 participants or records.
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