薬理と治療

Abstract

Background　The Japanese Society of Gout and Uric & Nucleic Acids 2019 Guidelines recommend a control target for serum uric acid level at 6.0 mg╱dL or less for patients suffering from gout with tophi. To achieve the control target, dotinurad, a novel uric acid-lowering drug classified as a selective urate reabsorption inhibitor, should be administered at the appropriate dosage. Methods 　A post hoc pooled analysis was performed to investigate the effects of dotinurad on lowering serum uric acid levels based on pretreatment uric acid levels in 420 patients with gout attacks, gouty tophi, or hyperuricemia in four clinical trials conducted from 2014 through 2018 in Japan. Results　To achieve the control target of serum uric acid level, a high maintenance dose of dotinurad was required when serum uric acid levels at pretreatment were high. The minimum maintenance doses of dotinurad were: 0.5 mg for pretreatment serum uric acid levels of 7.0-7.9 mg╱dL, 1 mg for 8.0-8.9 mg╱dL, and 2 mg for 9.0 mg╱dL or higher. There were no safety issues associated with dose escalation. Conclusions　The results of this study suggest that to maintain the control target of 6.0 mg╱dL, the maintenance dose of dotinurad should be escalated based on pretreatment serum uric acid levels.