Dotinurad: a novel selective urate reabsorption inhibitor for the treatment of hyperuricemia and gout

References

• Ministry of Health, Labour and Welfare. Comprehensive survey of living conditions. 2016.
   Google Scholar
• Koto R, Nakajima A, Horiuchi H, et al. Real-world treatment of gout and asymptomatic hyperuricemia: a cross-sectional study of Japanese health insurance claims data. Mod Rheumatol. 2021;31(1):261–269.
   PubMed Web of Science ®Google Scholar
• Hakoda M. Recent trends in hyperuricemia and gout in Japan. Japan Med Assoc J. 2012;55(4):319–323.
   PubMedGoogle Scholar
• Tomita M, Yokota K, Mizuno S. Significance of uric acid measurement in health checks and comprehensive medical examinations. Hyperuricemia and Gout. 2010;18:67–71.
   Google Scholar
• Campion EW, Glynn RJ, DeLabry LO. Asymptomatic hyperuricemia. Risks and consequences in the normative aging study. Am J Med. 1987;82(3):421–426.
   PubMedGoogle Scholar
• Lin KC, Lin HY, Chou P. The interaction between uric acid level and other risk factors on the development of gout among asymptomatic hyperuricemic men in a prospective study. J Rheumatol. 2000;27(6):1501–1505.
   PubMed Web of Science ®Google Scholar
• Sellmayr M, Hernandez Petzsche MR, Ma Q, et al. Only hyperuricemia with crystalluria, but not asymptomatic hyperuricemia, drives progression of chronic kidney disease. J Am Soc Nephrol. 2020;31(12):2773–2792.
   PubMed Web of Science ®Google Scholar
• Preitner F, Laverriere-Loss A, Metref S, et al. Urate-induced acute renal failure and chronic inflammation in liver-specific Glut9 knockout mice. Am J Physiol Renal Physiol. 2013;305(5):F786–795.
   PubMed Web of Science ®Google Scholar
• Iseki K, Ikemiya Y, Inoue T, et al. Significance of hyperuricemia as a risk factor for developing ESRD in a screened cohort. Am J Kidney Dis. 2004;44(4):642–650.
   PubMed Web of Science ®Google Scholar
• Obermayr RP, Temml C, Gutjahr G, et al. Elevated uric acid increases the risk for kidney disease. J Am Soc Nephrol. 2008;19(12):2407–2413.
   PubMed Web of Science ®Google Scholar
• Hisatome I, Li P, Miake J, et al. Uric acid as a risk factor for chronic kidney disease and cardiovascular disease japanese guideline on the management of Asymptomatic Hyperuricemia . Circ J. 2021;85(2):130–138.
   PubMed Web of Science ®Google Scholar
• Yin W, Zhou QL, OuYang SX, et al. Uric acid regulates NLRP3/IL-1β signaling pathway and further induces vascular endothelial cells injury in early CKD through ROS activation and K+ efflux. BMC Nephrol. 2019 Aug 14;20(1):319. PMID: 31412804; PMCID: PMC6694569.
   PubMed Web of Science ®Google Scholar
• Waheed YA, Yang F, Sun D. The role of asymptomatic hyperuricemia in the progression of chronic kidney disease CKD and cardiovascular diseases CVD. Korean J Intern Med. 2020 Oct 6. Doi: https://doi.org/10.3904/kjim.2020.340. Epub ahead of print. PMID: 33045808.
   Web of Science ®Google Scholar
• Ichida K, Matsuo H, Takada T, et al. Decreased extra-renal urate excretion is a common cause of hyperuricemia. Nat Commun. 2012;3(1):764.
   PubMedGoogle Scholar
• Hisatome I, Ichida K, Mineo I, et al. Japanese society of gout and uric & nucleic acids 2019 guidelines for management of hyperuricemia and gout 3rd edition. Gout and Uric & Nucleic Acids; 2020:44(Supplement):1–40.
   Google Scholar
• Otani N, Ouchi M, Kudo H, et al. Recent approaches to gout drug discovery: an update. Expert Opin Drug Discov. 2020;15(8):943–954.
   PubMed Web of Science ®Google Scholar
• Shahid H, Singh JA. Investigational drugs for hyperuricemia. Expert Opin Investig Drugs. 2015;24(8):1013–1030.
   PubMed Web of Science ®Google Scholar
• White WB, Saag KG, Becker MA, et al. Cardiovascular safety of febuxostat or allopurinol in patients with gout. N Engl J Med. 2018;378(13):1200–1210.
   PubMed Web of Science ®Google Scholar
• Mackenzie IS, Ford I, Nuki G, et al. Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial. Lancet. 2020;396(10264):1745–1757.
   PubMed Web of Science ®Google Scholar
• Van Der Klauw MM, Houtman PM, Stricker BH, et al. Hepatic injury caused by benzbromarone. J Hepatol. 1994;20(3):376–379.
   PubMed Web of Science ®Google Scholar
• Locuson CW II, Wahlstrom JL, Rock DA, et al. A new class of CYP2C9 inhibitors: probing 2C9 specificity with high-affinity benzbromarone derivatives. Drug Metab Dispos. 2003;31(7):967–971.
   PubMed Web of Science ®Google Scholar
• Taniguchi T, Ashizawa N, Matsumoto K, et al., Pharmacological evaluation of dotinurad, a selective urate reabsorption inhibitor. J Pharmacol Exp Ther. 2019;371(1):162–170.
   PubMed Web of Science ®Google Scholar
• Viljoen A, Chaudhry R, Bycroft J. Renal stones. Ann Clin Biochem. 2019;56(1):15–27.
   PubMed Web of Science ®Google Scholar
• Nakatani H, Fushimi M, Sasaki T, et al. Clinical pharmacological study of dotinurad administered to male and female elderly or young subjects. Clin Exp Nephrol. 2020;24(Suppl1):8–16.
   PubMedGoogle Scholar
• Fukase H, Okui D, Sasaki T, et al., Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor. Clin Exp Nephrol. 2020;24(Suppl1):17–24.
   PubMedGoogle Scholar
• Kumagai Y, Sakaki M, Furihata K, et al., Dotinurad: a clinical pharmacokinetic study of a novel, selective urate reabsorption inhibitor in subjects with hepatic impairment. Clin Exp Nephrol. 2020;24(Suppl1): 25–35.
   PubMedGoogle Scholar
• Hosoya T, Sano T, Sasaki T, et al., 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. Clin Exp Nephrol. 2020;24(Suppl1): 53–61.
   PubMedGoogle Scholar
• Hosoya T, Sano T, Sasaki T, et al., Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study. Clin Exp Nephrol. 2020;24(Suppl1): 62–70.
   PubMedGoogle Scholar
• Hosoya T, Furuno K, Kanda S. A non-inferiority study of the novel selective urate reabsorption inhibitor dotinurad versus febuxostat in hyperuricemic patients with or without gout. Clin Exp Nephrol. 2020;24(Suppl1):71–79.
   PubMedGoogle Scholar
• Hosoya T, Fushimi M, Okui D, et al., Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout. Clin Exp Nephrol. 2020;24(Suppl1): 80–91.
   PubMedGoogle Scholar
• Omura K, Miyata K, Kobashi S, et al. Ideal pharmacokinetic profile of dotinurad as a selective urate reabsorption inhibitor. Drug Metab Pharmacokinet. 2020;35(3):313–320.
   PubMed Web of Science ®Google Scholar
• Pharmaceutical safety and environmental health bureau, ministry of health, labour and welfare, Japan. Notification No. 0723-4, 2018, Guideline on drug interaction for drug development and appropriate provision of information. pp. 21–23. [ cited 2021 Jan 18]. Available from: https://www.pmda.go.jp/files/000228122.pdf [issued 2019 Feb 8]
   Google Scholar
• Furihata K, Nagasawa K, Hagino A, et al., A drug-drug interaction study of a novel, selective urate reabsorption inhibitor dotinurad and the non-steroidal anti-inflammatory drug oxaprozin in healthy adult males. Clin Exp Nephrol. 2020;24(Suppl1): 36–43.
   PubMedGoogle Scholar
• Lee WM. Drug-induced hepatotoxicity. N Engl J Med. 2003;349(5):474–485.
   PubMed Web of Science ®Google Scholar
• Nakayama S, Atsumi R, Takakusa H, et al. A zone classification system for risk assessment of idiosyncratic drug toxicity using daily dose and covalent binding. Drug Metab Dispos. 2009;37(9):1970–1977.
   PubMed Web of Science ®Google Scholar
• Yamada M, Miyamoto K, Matsumoto K, et al. Nonclinical investigation of dotinurad on the risk of liver toxicity. Jpn Pharmacol Ther. 2020;48(2):157–164.
   Google Scholar
• Hosoya T, Sano T, Sasaki T, et al., Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: an exploratory, randomized, multicenter, double-blind, placebo-controlled, parallel-group early phase 2 study. Clin Exp Nephrol. 2020;24(Suppl1): 44–52.
   PubMedGoogle Scholar
• Taniguchi T, Ashizawa N. Pharmacological properties and clinical efficacy of dotinurad (URECE® tablets), a novel hypouricemic agent. Nihon Yakurigaku Zasshi. 2020;155(6):426–434.
   PubMedGoogle Scholar