徳島大学 教育・研究者情報データベース(EDB)

1. (英) Tanaka A

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2. (英) Taguchi I

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3. (英) Hisauchi I

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4. (英) Yoshida H

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5. 島袋 充生

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6. (英) Hongo H

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7. (英) Ishikawa T

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8. (英) Kadokami T

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9. 八木 秀介([徳島大学.大学院医歯薬学研究部.医学域.医科学部門.内科系.地域・家庭医療学])

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10. 佐田 政隆([徳島大学.大学院医歯薬学研究部.医学域.医科学部門.内科系.循環器内科学])

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11. (英) Node K

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(英) Clinical effects of a selective urate reabsorption inhibitor dotinurad in patients with hyperuricemia and treated hypertension: a multicenter, prospective, exploratory study (DIANA)

(英) Dotinurad is a newer urate-lowering agent that selectively inhibits urate transporter 1 in the renal proximal tubule and increases urinary urate excretion. Currently, little is known about the clinical efficacies of dotinurad in patients with hyperuricemia and hypertension. The aim of this study was to assess the clinical effects of a selective urate reabsorption inhibitor dotinurad on serum uric acid (SUA) levels and relevant vascular markers in patients with hyperuricemia and treated hypertension. This investigator-initiated, multicenter, prospective, single-arm, open-label, exploratory clinical trial in Japan enrolled patients with hyperuricemia and treated hypertension who received a 24-week dotinurad therapy (a starting dose at 0.5 mg once daily and up-titrated to 2 mg once daily). The primary endpoint was a percentage change in the SUA level from baseline to week 24. The secondary endpoints were cardiovascular and metabolic measurements, including changes in the cardio-ankle vascular index (CAVI) and derivatives of reactive oxygen metabolites (d-ROMs) concentration at week 24. Fifty patients (mean age 70.5 ± 11.0 years, with 76.0% being men, and mean SUA level 8.5 ± 1.2 mg/dL) were included in the analysis. The percentage change from baseline in the SUA level at week 24 was - 35.8% (95% confidence interval [CI] - 39.7% to - 32.0%, P < 0.001), with approximately three quarters of patients achieving an SUA level of ≤ 6.0 mg/dL at week 24. The proportional changes from baseline in the geometric mean of CAVI and d-ROMs at week 24 were 0.96 (95% CI 0.92 to 1.00, P = 0.044) and 0.96 (95% CI 0.92 to 1.00, P = 0.044), respectively. In addition to meaningful SUA-lowering effects, 24 weeks of dotinurad therapy may favorably affect arterial stiffness and oxidative stress markers, suggesting off-target vascular protection of dotinurad. Further research is expected to verify our findings and elucidate the entire off-target effects of dotinurad. Trial registration jRCTs021210013, registration date June 24, 2021.

1. (英) Male
2. (英) Humans
3. (英) Middle Aged
4. (英) Aged
5. (英) Aged, 80 and over
6. (英) Female
7. (英) Hyperuricemia
8. (英) Uric Acid
9. (英) Prospective Studies
10. (英) Uricosuric Agents
11. (英) Hypertension

1. (英) Article.ELocationID: 238

2. (英) Article.ELocationID: 10.1186/s40001-023-01208-1

3. (英) Article.PublicationTypeList.PublicationType: Multicenter Study

4. (英) Article.PublicationTypeList.PublicationType: Journal Article

5. (英) KeywordList.Keyword: Arterial stiffness

6. (英) KeywordList.Keyword: Dotinurad

7. (英) KeywordList.Keyword: Hyperuricemia

8. (英) KeywordList.Keyword: Oxidative stress

9. (英) KeywordList.Keyword: Selective urate transporter 1 inhibitor

10. (英) CoiStatement: AT has received honoraria from Boehringer Ingelheim and research funding from GlaxoSmithKline, Takeda, Bristol Myers Squibb, and Novo Nordisk. HY has received lecture fee from Kyowa Kirin and outsourcing fees from Organization for Clinical Medicine Promotion. MS received honoraria from Mochida. SY has received honoraria from Bayer and Mitsubishi Tanabe. MS has received honoraria from Bayer, Mitsubishi Tanabe, Nippon Boehringer Ingelheim, Kowa, Novartis, and Mochida, as well as unrestricted research funding from Mitsubishi Tanabe, Nippon Boehringer Ingelheim, Bayer, and Otsuka. KN has received honoraria from Astellas, Bayer, Boehringer Ingelheim Japan, Daiichi Sankyo, Eli Lilly Japan, Kowa, Mitsubishi Tanabe, Mochida, Novartis, Novo Nordisk, Ono, Otsuka, Takeda, Tsumura, and MSD; research grant from Asahi Kasei, Astellas, Boehringer Ingelheim Japan, Fuji Yakuhin, Mitsubishi Tanabe, Mochida, Novartis, Teijin; scholarship from Bayern, Japan Lifeline, and Teijin. All other authors declare no competing interests.