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Article ; Online: Uric acid-lowering effect of dotinurad, a novel selective urate reabsorption inhibitor, in hypertensive patients with gout or asymptomatic hyperuricemia: a pooled analysis of individual participant data in phase II and III trials.

Takahashi, Toshinari / Beppu, Takanobu / Hidaka, Yuji / Hosoya, Tatsuo

Clinical and experimental hypertension (New York, N.Y. : 1993)

2021 Volume 43, Issue 8, Page(s) 730–741

Abstract: ... ...

Abstract	Background
MeSH term(s)	Benzothiazoles ; Clinical Trials, Phase II as Topic ; Gout/complications ; Gout/drug therapy ; Gout Suppressants/therapeutic use ; Humans ; Hypertension/complications ; Hypertension/drug therapy ; Hyperuricemia/complications ; Hyperuricemia/drug therapy ; Pharmaceutical Preparations ; Uric Acid ; Uricosuric Agents/therapeutic use
Chemical Substances	Benzothiazoles ; Gout Suppressants ; Pharmaceutical Preparations ; Uricosuric Agents ; Uric Acid (268B43MJ25) ; dotinurad (305EB53128)
Language	English
Publishing date	2021-08-23
Publishing country	England
Document type	Journal Article ; Meta-Analysis
ZDB-ID	604757-9
ISSN	1525-6006 ; 0730-0077
ISSN (online)	1525-6006
ISSN	0730-0077
DOI	10.1080/10641963.2021.1950752
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Article ; Online: Mass-like Lesions Causing Compression of Large Vessels in Granulomatosis with Polyangiitis.

Hanzawa, Satoshi / Noda, Seiji / Hosoya, Tadashi / Kawahara, Tatsuo / Nukui, Yoshihisa

Internal medicine (Tokyo, Japan)

2022 Volume 62, Issue 16, Page(s) 2427–2431

Abstract: A 69-year-old woman with a history of otitis media with anti-neutrophil cytoplasmic antibody-associated vasculitis who had been receiving corticosteroid monotherapy presented with shortness of breath. The otitis media had been alleviated, but she had ... ...

Abstract	A 69-year-old woman with a history of otitis media with anti-neutrophil cytoplasmic antibody-associated vasculitis who had been receiving corticosteroid monotherapy presented with shortness of breath. The otitis media had been alleviated, but she had saddle nose. Chest enhanced computed tomography showed stenoses of the bronchi and large vessels surrounded by mass-like lesions in the mediastinum. These manifestations indicated an active state of granulomatosis with polyangiitis (GPA). After she was started on high-dose corticosteroids and intravenous cyclophosphamide, the mass-like lesions disappeared with improvements of the stenoses. Ameliorating mass-like lesions resulting from GPA requires therapeutic intervention using corticosteroids and immunosuppressants.
MeSH term(s)	Female ; Humans ; Aged ; Granulomatosis with Polyangiitis/complications ; Granulomatosis with Polyangiitis/diagnosis ; Granulomatosis with Polyangiitis/drug therapy ; Constriction, Pathologic ; Cyclophosphamide/therapeutic use ; Adrenal Cortex Hormones/therapeutic use ; Otitis Media/drug therapy ; Antibodies, Antineutrophil Cytoplasmic/therapeutic use
Chemical Substances	Cyclophosphamide (8N3DW7272P) ; Adrenal Cortex Hormones ; Antibodies, Antineutrophil Cytoplasmic
Language	English
Publishing date	2022-12-28
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	32371-8
ISSN	1349-7235 ; 0021-5120 ; 0918-2918
ISSN (online)	1349-7235
ISSN	0021-5120 ; 0918-2918
DOI	10.2169/internalmedicine.0561-22
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Article: [110th Scientific Meeting of the Japanese Society of Internal Medicine: presidential lecture; internal medicine for variability among individuals].

Hosoya, Tatsuo

Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine

2013 Volume 102, Issue 9, Page(s) 2145–2151

MeSH term(s)	Humans ; Internal Medicine/trends ; Kidney/physiology ; Uric Acid/metabolism
Chemical Substances	Uric Acid (268B43MJ25)
Language	Japanese
Publishing date	2013-10-31
Publishing country	Japan
Document type	Journal Article
ZDB-ID	952816-7
ISSN	1883-2083 ; 0021-5384
ISSN (online)	1883-2083
ISSN	0021-5384
DOI	10.2169/naika.102.2145
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Article: [The 40th scientific meeting: perspectives of internal medicine; present situation and future extension of organ transplantation in Japan; 1. Preface].

Hosoya, Tatsuo

Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine

2013 Volume 102, Issue 3, Page(s) 543–544

MeSH term(s)	Humans ; Internal Medicine/trends ; Japan ; Organ Transplantation/legislation & jurisprudence ; Organ Transplantation/trends
Language	Japanese
Publishing date	2013-05-21
Publishing country	Japan
Document type	Introductory Journal Article
ZDB-ID	952816-7
ISSN	1883-2083 ; 0021-5384
ISSN (online)	1883-2083
ISSN	0021-5384
DOI	10.2169/naika.102.543
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Zs.B 594: Show issues

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Article ; Online: Dotinurad: a novel selective urate reabsorption inhibitor for the treatment of hyperuricemia and gout.

Ishikawa, Tomohiko / Takahashi, Toshinari / Taniguchi, Tetsuya / Hosoya, Tatsuo

Expert opinion on pharmacotherapy

2021 Volume 22, Issue 11, Page(s) 1397–1406

Abstract: Introduction: Gout is an inflammatory disease triggered by deposition of urate crystals secondary to longstanding hyperuricemia, and its management implies both the treatment of flares and management of hyperuricemia. Dotinurad is a selective urate ... ...

Abstract	Introduction: Gout is an inflammatory disease triggered by deposition of urate crystals secondary to longstanding hyperuricemia, and its management implies both the treatment of flares and management of hyperuricemia. Dotinurad is a selective urate reabsorption inhibitor (SURI), potently inhibits urate transporter 1 in the apical surface of renal proximal tubular cells, and has been approved for the treatment of gout and hyperuricemia in Japan. Areas covered: This overview of dotinurad covers nonclinical and clinical pharmacology studies in special populations and its efficacy and safety in Japanese hyperuricemic patients with and without gout. Expert opinion: Dotinurad, as an SURI, is expected to inhibit urate reabsorption more effectively than conventional urate-lowering agents. It is noninferior to benzbromarone or febuxostat in reducing serum urate levels in hyperuricemic patients with or without gout. Its efficacy is not attenuated in patients with mild to moderate renal impairment or with hepatic impairment. At a maintenance dose of 2 or 4 mg once daily, most patients achieved the target serum urate level of ≤6 mg/dL in a long-term study. No findings that raised safety concerns, including liver injury, were identified. Dotinurad is expected to be a new therapeutic option in hyperuricemic patients with and without gout.
MeSH term(s)	Benzothiazoles ; Febuxostat/therapeutic use ; Gout/drug therapy ; Gout Suppressants/therapeutic use ; Humans ; Hyperuricemia/drug therapy ; Uric Acid ; Uricosuric Agents/therapeutic use
Chemical Substances	Benzothiazoles ; Gout Suppressants ; Uricosuric Agents ; Febuxostat (101V0R1N2E) ; Uric Acid (268B43MJ25) ; dotinurad (305EB53128)
Language	English
Publishing date	2021-04-30
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2001535-5
ISSN	1744-7666 ; 1465-6566
ISSN (online)	1744-7666
ISSN	1465-6566
DOI	10.1080/14656566.2021.1918102
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Zs.A 5130: Show issues

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Article ; Online: Comparative study of a novel selective urate reabsorption inhibitor "dotinurad" among patient groups with different stages of renal dysfunction.

Takahashi, Toshinari / Beppu, Takanobu / Hidaka, Yuji / Hosoya, Tatsuo

Clinical and experimental nephrology

2021 Volume 25, Issue 12, Page(s) 1336–1345

Abstract: Background: Dotinurad is a selective urate reabsorption inhibitor (SURI), which selectively inhibits URAT1 to lower serum uric acid levels in patients with hyperuricemia. Herein, the effects of dotinurad were compared among patient groups with different ...

Abstract	Background: Dotinurad is a selective urate reabsorption inhibitor (SURI), which selectively inhibits URAT1 to lower serum uric acid levels in patients with hyperuricemia. Herein, the effects of dotinurad were compared among patient groups with different stages of renal dysfunction. Methods: Patient data from four clinical trials were pooled and divided into four groups according to the stage of renal dysfunction to compare the effects of dotinurad at different stages. The grouping (stages G1-G3b) was based on the estimated glomerular filtration rate (eGFR) of the patients. In addition, patient data from a long-term study (34 or 58 weeks) were evaluated in the same manner. Results: In the pooled analysis, the percentage of patients achieving a serum uric acid level of ≤ 6.0 mg/dL was 64.7-100.0% at a dose of 2 or 4 mg. In the long-term analysis, the percentage of patients achieving a serum uric acid level of ≤ 6.0 mg/dL was 60.0-100.0% at a dose of 2 or 4 mg. Although the outcomes in stage G3b were worse due to higher baseline serum uric acid levels, satisfactory outcomes were observed in all stages. Even in stages G3a and G3b, when renal function declined, the eGFR remained constant throughout the dose period. Conclusion: The efficacy of dotinurad was confirmed in hyperuricemic patients with normal renal function (stage G1) and mild to moderate renal dysfunction (stage G2-G3b). Dotinurad was found to be effective in the treatment of hyperuricemia in patients with mild to moderate renal dysfunction.
MeSH term(s)	Adult ; Aged ; Benzothiazoles/adverse effects ; Benzothiazoles/therapeutic use ; Biomarkers/blood ; Clinical Trials as Topic ; Female ; Glomerular Filtration Rate ; Humans ; Hyperuricemia/blood ; Hyperuricemia/diagnosis ; Hyperuricemia/drug therapy ; Hyperuricemia/physiopathology ; Kidney/drug effects ; Kidney/metabolism ; Kidney/physiopathology ; Kidney Diseases/diagnosis ; Kidney Diseases/physiopathology ; Male ; Middle Aged ; Renal Reabsorption/drug effects ; Treatment Outcome ; Uric Acid/blood ; Uricosuric Agents/adverse effects ; Uricosuric Agents/therapeutic use
Chemical Substances	Benzothiazoles ; Biomarkers ; Uricosuric Agents ; Uric Acid (268B43MJ25) ; dotinurad (305EB53128)
Language	English
Publishing date	2021-07-30
Publishing country	Japan
Document type	Comparative Study ; Journal Article
ZDB-ID	1338768-6
ISSN	1437-7799 ; 1342-1751
ISSN (online)	1437-7799
ISSN	1342-1751
DOI	10.1007/s10157-021-02115-7
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Zs.A 4922: Show issues

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Article ; Online: A clinical pharmacology study of the novel, selective urate reabsorption inhibitor dotinurad in outpatients.

Hosoya, Tatsuo / Furuno, Kazuki / Kanda, Shingo

Clinical and experimental nephrology

2020 Volume 24, Issue Suppl 1, Page(s) 103–111

Abstract: Background: Dotinurad is a novel, selective urate reabsorption inhibitor (SURI), which reduces serum uric acid levels by selective inhibition of the urate transporter 1 (URAT1). The Japanese guideline for the management of hyperuricemia and gout ... ...

Abstract	Background: Dotinurad is a novel, selective urate reabsorption inhibitor (SURI), which reduces serum uric acid levels by selective inhibition of the urate transporter 1 (URAT1). The Japanese guideline for the management of hyperuricemia and gout recommends that drug selection should be based on classification of hyperuricemia as a fundamental principle. However, there may be some cases where this principle is not observed. We investigated the pharmacodynamics and safety of dotinurad in outpatients with uric acid overproduction or uric acid underexcretion type. Methods: This was a multicenter, open-label, forced titration study. Patients were classified as uric acid overproduction or underexcretion type. Study treatment was initiated at 0.5 mg/day, followed by dose titration to the estimated maximum dose of 4 mg/day over 14 weeks. The primary endpoint was urinary uric acid excretion at each 24-h urine collection. Results: A total of 26 hyperuricemic patients with or without gout were enrolled in the study and assigned to the uric acid overproduction group (overproduction group) or the uric acid underexcretion group (underexcretion group). Although urinary uric acid excretion, the primary endpoint, tended to be slightly greater in the overproduction group, no notable difference was noted between the two hyperuricemic types. Neither type had noteworthy safety concerns associated with dotinurad. Conclusion: The results of the study demonstrated no relevant differences between the hyperuricemic types in terms of pharmacodynamic action and safety of dotinurad.
MeSH term(s)	Adult ; Aged ; Benzothiazoles/adverse effects ; Benzothiazoles/pharmacology ; Benzothiazoles/therapeutic use ; Humans ; Hyperuricemia/classification ; Hyperuricemia/drug therapy ; Japan ; Male ; Middle Aged ; Outpatients ; Uric Acid/blood ; Uric Acid/urine ; Uricosuric Agents/therapeutic use
Chemical Substances	Benzothiazoles ; Uricosuric Agents ; Uric Acid (268B43MJ25) ; dotinurad (305EB53128)
Language	English
Publishing date	2020-02-18
Publishing country	Japan
Document type	Clinical Trial ; Journal Article ; Multicenter Study
ZDB-ID	1338768-6
ISSN	1437-7799 ; 1342-1751
ISSN (online)	1437-7799
ISSN	1342-1751
DOI	10.1007/s10157-020-01857-0
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Article ; Online: A non-inferiority study of the novel selective urate reabsorption inhibitor dotinurad versus febuxostat in hyperuricemic patients with or without gout.

Hosoya, Tatsuo / Furuno, Kazuki / Kanda, Shingo

Clinical and experimental nephrology

2020 Volume 24, Issue Suppl 1, Page(s) 71–79

Abstract: Background: Dotinurad is a novel, selective urate reabsorption inhibitor, which reduces serum uric acid levels by selective inhibition of the urate transporter 1. We evaluated the efficacy and safety of dotinurad versus febuxostat, a widely used drug in ...

Abstract	Background: Dotinurad is a novel, selective urate reabsorption inhibitor, which reduces serum uric acid levels by selective inhibition of the urate transporter 1. We evaluated the efficacy and safety of dotinurad versus febuxostat, a widely used drug in Japan, in hyperuricemic Japanese patients with or without gout. Methods: This was a multicenter, randomized, double-blind, active-controlled, parallel-group, forced-titration study in hyperuricemic patients. Study treatment in the dotinurad and febuxostat groups was initiated at 0.5 and 10 mg/day, followed by dose titration to 2 and 40 mg/day, respectively, over 14 weeks. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit. Results: A total of 203 hyperuricemic patients with or without gout were enrolled in the study and randomized to receive dotinurad or febuxostat. The percent change in serum uric acid level from the baseline to the final visit was 41.82% in the dotinurad group and 44.00% in the febuxostat group. The mean difference was - 2.17% (two-sided 95% confidence interval - 5.26% to 0.92%). The lower limit of the interval was above the non-inferiority margin (- 10%), demonstrating the non-inferiority of dotinurad to febuxostat. The profiles of adverse events and adverse drug reactions raised no noteworthy safety concerns in either group. Conclusion: The non-inferiority of dotinurad to febuxostat in terms of serum uric acid lowering effect was confirmed. No noteworthy safety concerns arose.
MeSH term(s)	Adult ; Aged ; Benzothiazoles/administration & dosage ; Benzothiazoles/adverse effects ; Benzothiazoles/therapeutic use ; Double-Blind Method ; Febuxostat/administration & dosage ; Febuxostat/adverse effects ; Febuxostat/therapeutic use ; Gout/drug therapy ; Humans ; Hyperuricemia/drug therapy ; Japan ; Male ; Middle Aged ; Treatment Outcome ; Uric Acid/blood ; Uricosuric Agents/therapeutic use
Chemical Substances	Benzothiazoles ; Uricosuric Agents ; Febuxostat (101V0R1N2E) ; Uric Acid (268B43MJ25) ; dotinurad (305EB53128)
Language	English
Publishing date	2020-01-22
Publishing country	Japan
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	1338768-6
ISSN	1437-7799 ; 1342-1751
ISSN (online)	1437-7799
ISSN	1342-1751
DOI	10.1007/s10157-020-01851-6
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Article ; Online: Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study.

Hosoya, Tatsuo / Sano, Takafumi / Sasaki, Tomomitsu / Fushimi, Masahiko / Ohashi, Tetsuo

Clinical and experimental nephrology

2020 Volume 24, Issue Suppl 1, Page(s) 62–70

Abstract: Background: Dotinurad is a novel selective urate reabsorption inhibitor that reduces serum urate levels in hyperuricemic patients with or without gout by selectively inhibiting urate transporter 1. This study was conducted to compare the efficacy and ... ...

Abstract	Background: Dotinurad is a novel selective urate reabsorption inhibitor that reduces serum urate levels in hyperuricemic patients with or without gout by selectively inhibiting urate transporter 1. This study was conducted to compare the efficacy and safety of dotinurad with those of benzbromarone. Methods: In this 14-week, randomized, multicenter, double-blind, parallel-group, dose escalation, benzbromarone-controlled, phase 3 study, hyperuricemic patients with or without gout were randomized to two groups that received either dotinurad 2 mg or benzbromarone 50 mg. Dotinurad or benzbromarone was administered once a day for 14 weeks. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit. Results: A total of 201 Japanese hyperuricemic patients with or without gout (dotinurad: 102, benzbromarone: 99) received at least one dose of the study drug. The mean percent change in serum uric acid level from the baseline to the final visit in the dotinurad and benzbromarone groups was 45.9% and 43.8%, respectively. Non-inferiority of dotinurad 2 mg to benzbromarone 50 mg in lowering serum uric acid was verified by the predefined non-inferiority margin (95% CI - 1.27 to 5.37%). The incidence of adverse events and adverse drug reactions was comparable between the two groups. Conclusion: Dotinurad 2 mg was verified to have a non-inferior serum uric acid lowering effect compared with benzbromarone 50 mg, in Japanese hyperuricemic patients with or without gout. CLINICALTRIALS. Gov identifier: NCT03100318.
MeSH term(s)	Adult ; Aged ; Benzbromarone/administration & dosage ; Benzbromarone/adverse effects ; Benzothiazoles/administration & dosage ; Benzothiazoles/adverse effects ; Double-Blind Method ; Female ; Gout/drug therapy ; Humans ; Hyperuricemia/classification ; Hyperuricemia/drug therapy ; Japan ; Male ; Middle Aged ; Treatment Outcome ; Uric Acid/blood ; Uricosuric Agents/administration & dosage
Chemical Substances	Benzothiazoles ; Uricosuric Agents ; Uric Acid (268B43MJ25) ; dotinurad (305EB53128) ; Benzbromarone (4POG0RL69O)
Language	English
Publishing date	2020-01-24
Publishing country	Japan
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	1338768-6
ISSN	1437-7799 ; 1342-1751
ISSN (online)	1437-7799
ISSN	1342-1751
DOI	10.1007/s10157-020-01849-0
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Article: [Gout and hyperuricemia: Introduction].

Hosoya, Tatsuo

Nihon rinsho. Japanese journal of clinical medicine

2008 Volume 66, Issue 4, Page(s) 621–623

MeSH term(s)	Drug Design ; Gout ; Gout Suppressants ; Humans ; Hyperuricemia/etiology ; Hyperuricemia/therapy ; Medicine ; Organic Anion Transporters/genetics ; Organic Cation Transport Proteins/genetics ; Practice Guidelines as Topic ; Specialization
Chemical Substances	Gout Suppressants ; Organic Anion Transporters ; Organic Cation Transport Proteins ; SLC22A12 protein, human
Language	Japanese
Publishing date	2008-04
Publishing country	Japan
Document type	Introductory Journal Article
ZDB-ID	390903-7
ISSN	0047-1852
ISSN	0047-1852
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