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Survey of dotinurad use in hyperuricemic patients with impaired renal function
-A retrospective observational study-

Survey of dotinurad use in hyperuricemic patients with impaired renal function
-A retrospective observational study-

298

Cases with a history of dotinurad prescription (n=414) Cases that meet the selection criteria (n=404) Cases that do not violate the selection/exclusion criteria (n=359) Cases included in the analysis (FAS) (n=298) Cases included in the analysis (PPS) (n=284)

The results were published within the scheduled research period (until March 31, 2025).

No occurrence due to retrospective observational study

The study included 298 patients (219 men and 79 women), with a mean age of 68.2 +- 15.0 years. The number of patients by GFR category was as follows: G1,2: 51 patients (17.1%), G3a: 70 patients (23.5%), G3b: 87 patients (29.2%), G4: 64 patients (21.5%), and G5: 26 patients (8.7%). In addition, 215 patients (72.1%) were naive to dotinurad, 46 patients (15.4%) were switching to dotinurad, and 37 patients (12.4%) were using dotinurad concomitantly. In all subjects, serum uric acid levels significantly decreased from 8.25 (8.04-8.46) mg/dL [point estimate (95% confidence interval)] at baseline to 6.10 (5.97-6.22) mg/dL after 12 months. The percentage of patients achieving a serum uric acid level of 6.0 mg/dL or less at 12 months post-initiation was 56.8% (50.0-63.4) overall, with the following percentages by GFR category, G1,2: 58.7% (44.4-71.7), G3a: 49.4% (34.8-64.1), G3b: 55.8% (40.0-70.4), G4: 65.3% (52.8-75.9), and G5: 46.0% (25.1-68.4). Furthermore, a significant decrease in serum uric acid was observed regardless of whether the status at the time of starting dotinurad treatment was naive, switched, or concomitant use. The uric acid-lowering effect of dotinurad was supported by changes in the uric acid excretion rate. In patients with GFR classifications G3a, G3b, and G4, a significant improvement in the eGFR slope was observed after the start of dotinurad treatment.

Dotinurad demonstrated a serum uric acid-lowering effect even in patients with hyperuricemia complicated by chronic kidney disease, including those with severely reduced renal function, suggesting a potential renal protective effect.

Mar. 28, 2025

Jan. 08, 2025

https://www.shinryo-to-shinyaku.com/sin_0061_11.html

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1051230149

Shimazu keiji

Osaka Saiseikai Nakatsu Hospital.

2-10-39 Shibata, Kita-ward, Osaka city, Osaka prefecture

k_shimazu@nakatsu.saiseikai.or.jp

Shimazu keiji

Osaka Saiseikai Nakatsu Hospital.

2-10-39 Shibata, Kita-ward, Osaka city, Osaka prefecture

+81-6-6372-0333

k_shimazu@nakatsu.saiseikai.or.jp

Complete

Dec. 21, 2023

Observational

1)Of the patients who were prescribed dotinurad at Osaka Saiseikai Nakatsu Hospital (hereafter referred to as "this hospital") during the study period, those patients could be classified into eGFR categories G1 to G5 at the start of dotinurad administration.
2)Patients (of any gender) 20 years of age or older at the start of dotinurad treatment.

1)Patients who visited our clinic after being started on dotinurad at another medical institution (patients who were already taking dotinurad at the time of their first visit to our clinic).
2)Patients who indicated their intention not to participate by opting out.

Both

Patients with hyperuricemia (renal function as eGFR category G1-G5)

Percentage of patients achieving a serum uric acid level of 6.0 mg/dL or less at 12 months after the start of treatment with dotinurad

1)Percentage of patients achieving serum uric acid levels of 6.0 mg/dL or less and 7.0 mg/dL or less at 3, 6, and 12 months after the start of dotinurad treatment (excluding assessments related to the primary endpoint)
2)Serum uric acid level and its change (rate and amount) at 3, 6, and 12 months after the start of dotinurad administration
3)eGFR and its change (rate and amount) at 3, 6, and 12 months after the start of dotinurad treatment
4)Serum uric acid levels for each of the 12 months before and after the start of treatment with dotinurad
5)eGFR at 12 months before and after the start of treatment with dotinurad

+81-6-6372-0333

Dec. 01, 2023

none