Real-World Effectiveness and Safety of Dotinurad in Chinese Patients with Gout: A Comparative Analysis.

Abstract

Background: Dotinurad, a novel selective uric acid (UA) reabsorption inhibitor, exerts its hypouricemic effect through the selective inhibition of urate transporter 1 (URAT1). The present study aimed to investigate the short-term effectiveness and safety of dotinurad in the treatment of Chinese patients with gout, while also conducting a comparative analysis with febuxostat.

Methods: This retrospective study enrolled 70 consecutive eligible inpatients and outpatients with gout from the Department of Rheumatology and Immunology, The Affiliated Guangdong Second Provincial General Hospital of Jinan University, were screened during the period from 1 January 2025 to 30 December 2025. Treatment was prescribed at the discretion of the treating clinician: 35 patients receiving dotinurad and 35 receiving febuxostat. The primary analyses focused on serum uric acid (UA) target attainment (≤ 360 μmol/L or ≤ 300 μmol/L) for patients with dotinurad or febuxostat) and short-term urate-lowering effectiveness after 4 weeks of treatment. Short-term changes in hepatic and renal function parameters were also evaluated.

Results: After one month of treatment, the attainment rates for UA ≤ 360 μmol/L in the dotinurad group and the febuxostat group were 60.0% and 45.7%, respectively. The attainment rates for UA ≤ 300 μmol/L were 45.7% and 14.3%, respectively. While baseline UA levels did not differ significantly between the two groups (P = 0.227), a significant difference was observed after 4 weeks of treatment (The serum UA levels at week-4 after treatment in the dotinurad group and febuxostat group were 294.47 ± 19.31 and 380.85 ± 21.43, respectively; P = 0.003). After one month of treatment, significant intergroup differences were observed in the changes from baseline of UA and serum creatinine (SCR) (P = 0.003 and P = 0.029, respectively), whereas no statistically significant intergroup differences were found in the changes from baseline of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (P = 0.761 and P = 0.551, respectively).

Conclusions: It was found that 2 mg/day of Dotinurad was superior to 40 mg/day of febuxostat in achieving serum UA levels ≤ 360 μmol/L or ≤ 300 μmol/L after 4 weeks in Chinese patients with gout and exerted superior short-term urate-lowering effectiveness to febuxostat. Additionally, dotinurad is not associated with a risk of hepatic or renal injury in the short term, whereas febuxostat may increase SCR levels over the short course. The conclusions are only applicable to the clinical medication setting where febuxostat is initiated at a dose of 40 mg in Chinese patients with gout.