当前位置： SCI文献检索 > Clinical and Experimental Nephrology期刊下所有文献 > Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study.

Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study.

Abstract：

BACKGROUND:Dotinurad, a novel selective urate reabsorption inhibitor (SURI), reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1) for the treatment of hyperuricemia with or without gout. We confirmed the serum uric acid lowering effect and safety of dotinurad. METHODS:This was a confirmatory, 12-week, randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose escalation, late phase 2 study. The study arms were dotinurad 0.5, 1, 2, or 4 mg and placebo. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit. The secondary endpoint was the percentage of patients achieving a serum uric acid level ≤ 6.0 mg/dL at the final visit. RESULTS:The study drugs were administered to 200 Japanese hyperuricemic patients with or without gout. The mean percent change in serum uric acid level from the baseline to the final visit in the dotinurad 0.5, 1, 2, and 4 mg groups and the placebo group was 21.81%, 33.77%, 42.66%, 61.09%, and - 2.83%, respectively. The percentage of patients achieving a serum uric acid level ≤ 6.0 mg/dL at the final visit in each group was 23.1%, 65.9%, 74.4%, 100%, and none, respectively. Regarding safety, the incidence of adverse events did not increase with dose escalation in the dotinurad groups. No significant differences were observed in the incidence of gouty arthritis in each group. CONCLUSION:The serum uric acid lowering effect and safety of dotinurad were confirmed in hyperuricemic patients with or without gout. CLINICALTRIALS. GOV IDENTIFIER:NCT02416167.

journal_name

Clin Exp Nephrol

journal_title

Clinical and experimental nephrology

authors

Hosoya T,Sano T,Sasaki T,Fushimi M,Ohashi T

doi

10.1007/s10157-019-01818-2

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

53-61

issue

Suppl 1

eissn

1342-1751

issn

1437-7799

pii

10.1007/s10157-019-01818-2

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study.