{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T02:10:31Z","timestamp":1792807831525,"version":"4.5.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"S1","license":[{"start":{"date-parts":[[2020,1,22]],"date-time":"2020-01-22T00:00:00Z","timestamp":1579651200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,1,22]],"date-time":"2020-01-22T00:00:00Z","timestamp":1579651200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Exp Nephrol"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u00a0mg\/day, followed by dose titration to 2 and 40\u00a0mg\/day, respectively, over 14\u00a0weeks. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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 \u2212\u20092.17% (two-sided 95% confidence interval \u2212\u20095.26% to 0.92%). The lower limit of the interval was above the non-inferiority margin (\u2212\u200910%), 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The non-inferiority of dotinurad to febuxostat in terms of serum uric acid lowering effect was confirmed. No noteworthy safety concerns arose.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10157-020-01851-6","type":"journal-article","created":{"date-parts":[[2020,1,22]],"date-time":"2020-01-22T08:02:52Z","timestamp":1579680172000},"page":"71-79","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["A non-inferiority study of the novel selective urate reabsorption inhibitor dotinurad versus febuxostat in hyperuricemic patients with or without gout"],"prefix":"10.1007","volume":"24","author":[{"given":"Tatsuo","family":"Hosoya","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuki","family":"Furuno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shingo","family":"Kanda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,1,22]]},"reference":[{"key":"1851_CR1","unstructured":"Japanese Society of Gout and Nucleic Acid Metabolism. Japanese guideline for the management of hyperuricemia and gout: 2nd ed. Osaka: Medical Review Co., Ltd; 2010. p. 30\u20131, p. 79\u201382, p. 95\u20138."},{"key":"1851_CR2","unstructured":"Japanese Society of Gout and Nucleic Acid Metabolism. Japanese guideline for the management of hyperuricemia and gout: 3rd ed. Osaka: Medical Review Co., Ltd; 2018. p. 72\u20133, p. 95\u20138, p. 99\u2013101."},{"key":"1851_CR3","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1053\/j.ajkd.2005.10.006","volume":"47","author":"YP Siu","year":"2006","unstructured":"Siu YP, Leung KT, Tong MK, et al. Use of allopurinol in slowing the progression of renal disease through its ability to lower serum uric acid level. 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KF and SK are employees of Mochida Pharmaceutical Co. Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted according to the Declaration of Helsinki, International Committee on Harmonization Good Clinical Practice guideline, and applicable local laws and regulations. The protocol was approved by the regulatory authorities in Japan and by the ethics committees of study centre. All patients provided written informed consent before starting any procedure in this study. The information of this study was registered with Clinical Trials.gov (ClinicalTrials.gov number: NCT03372200).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical standards"}}]}}