Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor
Clinical and Experimental Nephrology, ISSN: 1437-7799, Vol: 24, Issue: Suppl 1, Page: 17-24
2020
- 5Citations
- 12Captures
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
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Metrics Details
- Citations5
- Citation Indexes5
- CrossRef4
- Captures12
- Readers12
- 12
Article Description
Background: Dotinurad, a novel selective urate reabsorption inhibitor, exerts a serum uric acid-lowering effect by selectively inhibiting urate transporter 1 (URAT1) in patients with hyperuricemia. It is generally known that the progression of renal dysfunction is associated with a reduction in the serum uric acid-lowering effects of uricosuric drugs. We, therefore, investigated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of dotinurad in subjects with renal dysfunction. Methods: This was a parallel-group, open-label, single-dose clinical pharmacology study. Dotinurad (1 mg) was administered once, orally to subjects with mild (estimated glomerular filtration rate [eGFR], ≥ 60 to < 90 mL/min/1.73 m) or moderate (eGFR, ≥ 30 to < 60 mL/min/1.73 m) renal dysfunction or normal (eGFR, ≥ 90 mL/min/1.73 m) renal function. Results: The time-course of mean plasma concentration of dotinurad had similar profiles across the groups. Regarding PK, there was no significant difference between the renal dysfunction groups and normal renal function group. Regarding PD, the maximum reduction rate in serum uric acid levels and the fractional uric acid excretion (FE) ratio (FE/FE) were significantly lower in the moderate renal dysfunction group than in the normal renal function group. However, other PD parameters were not significantly different among the groups. No notable adverse events or adverse drug reactions were observed in this study. Conclusion: These results suggested that no dose adjustment might be necessary when administering dotinurad to patients with mild-to-moderate renal dysfunction. ClinicalTrials.gov Identifier: NCT02347046.
Bibliographic Details
http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85076603693&origin=inward; http://dx.doi.org/10.1007/s10157-019-01825-3; https://clinicaltrials.gov/ct2/show/NCT02347046; http://www.ncbi.nlm.nih.gov/pubmed/31823130; https://link.springer.com/10.1007/s10157-019-01825-3; https://dx.doi.org/10.1007/s10157-019-01825-3; https://link.springer.com/article/10.1007/s10157-019-01825-3
Springer Science and Business Media LLC
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