Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.
Medical R&D Division, Development Department, Fuji Yakuhin Co., Ltd., 4-383, Sakuragi-cho, Omiya-ku, Saitama-shi, Saitama, 330-9508, Japan.
Clin Exp Nephrol. 2020 Mar;24(Suppl 1):62-70. doi: 10.1007/s10157-020-01849-0. Epub 2020 Jan 24.
Dotinurad is a novel selective urate reabsorption inhibitor that reduces serum urate levels in hyperuricemic patients with or without gout by selectively inhibiting urate transporter 1. This study was conducted to compare the efficacy and safety of dotinurad with those of benzbromarone.
In this 14-week, randomized, multicenter, double-blind, parallel-group, dose escalation, benzbromarone-controlled, phase 3 study, hyperuricemic patients with or without gout were randomized to two groups that received either dotinurad 2 mg or benzbromarone 50 mg. Dotinurad or benzbromarone was administered once a day for 14 weeks. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit.
A total of 201 Japanese hyperuricemic patients with or without gout (dotinurad: 102, benzbromarone: 99) received at least one dose of the study drug. The mean percent change in serum uric acid level from the baseline to the final visit in the dotinurad and benzbromarone groups was 45.9% and 43.8%, respectively. Non-inferiority of dotinurad 2 mg to benzbromarone 50 mg in lowering serum uric acid was verified by the predefined non-inferiority margin (95% CI - 1.27 to 5.37%). The incidence of adverse events and adverse drug reactions was comparable between the two groups.
Dotinurad 2 mg was verified to have a non-inferior serum uric acid lowering effect compared with benzbromarone 50 mg, in Japanese hyperuricemic patients with or without gout. CLINICALTRIALS.
NCT03100318.
多尼努拉德是一种新型选择性尿酸重吸收抑制剂，通过选择性抑制尿酸转运蛋白 1，可降低高尿酸血症患者（无论是否患有痛风）的血清尿酸水平。本研究旨在比较多尼努拉德与苯溴马隆的疗效和安全性。
这是一项为期 14 周、随机、多中心、双盲、平行分组、剂量递增、苯溴马隆对照的 3 期研究，纳入了伴有或不伴有痛风的高尿酸血症患者，将其随机分为两组，分别接受多尼努拉德 2mg 或苯溴马隆 50mg 治疗。多尼努拉德或苯溴马隆每天给药 1 次，持续 14 周。主要终点为从基线到最后一次访视时血清尿酸水平的变化百分比。
共有 201 例日本伴有或不伴有痛风的高尿酸血症患者（多尼努拉德组 102 例，苯溴马隆组 99 例）至少接受了 1 次研究药物治疗。多尼努拉德组和苯溴马隆组从基线到最后一次访视时血清尿酸水平的平均变化百分比分别为 45.9%和 43.8%。多尼努拉德 2mg 降低血清尿酸的非劣效性通过预设的非劣效性边界（95%CI-1.27 至 5.37%）得到验证。两组不良事件和药物不良反应的发生率相当。
在伴有或不伴有痛风的日本高尿酸血症患者中，与苯溴马隆 50mg 相比，多尼努拉德 2mg 具有非劣效的降低血清尿酸作用。临床试验。
NCT03100318。
