{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T22:03:51Z","timestamp":1770329031766,"version":"3.49.0"},"reference-count":50,"publisher":"Public Library of Science (PLoS)","issue":"3","license":[{"start":{"date-parts":[[2021,3,15]],"date-time":"2021-03-15T00:00:00Z","timestamp":1615766400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Taisho Pharmaceutical Co., Ltd"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\"><jats:title>Aims<\/jats:title><jats:p>The safety and efficacy, particularly, the factors associated with the renal prognosis, were assessed over 12 months after the initiation of luseogliflozin therapy in Japanese patients with type 2 diabetes and renal impairment.<\/jats:p><\/jats:sec><jats:sec id=\"sec002\"><jats:title>Methods<\/jats:title><jats:p>In total, 238 patients treated with luseogliflozin (2.5 mg, once daily) were studied as the safety analysis set. Two hundred and two subjects whose medication was continued over 12 months were investigated as the full analysis set. The subjects were divided into 3 groups based on the estimated glomerular filtration rate (eGFR): high eGFR (<jats:italic>n<\/jats:italic>= 49), normal eGFR (<jats:italic>n<\/jats:italic>= 116) and low eGFR (<jats:italic>n<\/jats:italic>= 37) groups.<\/jats:p><\/jats:sec><jats:sec id=\"sec003\"><jats:title>Results<\/jats:title><jats:p>The body weight, systolic blood pressure, HbA1c and urinary protein excretion gradually decreased from baseline in all eGFR groups. While the eGFR was significantly reduced from baseline in the high and normal eGFR groups, the eGFR did not significantly differ over time in the low eGFR group. There was no marked difference in the frequency of adverse events that were specific for SGLT2 inhibitors among the 3 groups in the safety analysis set.<\/jats:p><\/jats:sec><jats:sec id=\"sec004\"><jats:title>Conclusions<\/jats:title><jats:p>Luseogliflozin can preserve the renal function in the medium term in patients with type 2 diabetes and renal impairment without an increase in specific adverse events.<\/jats:p><\/jats:sec>","DOI":"10.1371\/journal.pone.0248577","type":"journal-article","created":{"date-parts":[[2021,3,15]],"date-time":"2021-03-15T17:30:49Z","timestamp":1615829449000},"page":"e0248577","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":10,"title":["Different renoprotective effects of luseogliflozin depend on the renal function at the baseline in patients with type 2 diabetes: A retrospective study during 12 months before and after initiation"],"prefix":"10.1371","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8143-0082","authenticated-orcid":true,"given":"Hiroyuki","family":"Ito","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suzuko","family":"Matsumoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takuma","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eiji","family":"Kusano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiro","family":"Kondo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideyuki","family":"Inoue","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinichi","family":"Antoku","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoko","family":"Yamasaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiko","family":"Mori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michiko","family":"Togane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2021,3,15]]},"reference":[{"key":"pone.0248577.ref001","doi-asserted-by":"crossref","first-page":"152","DOI":"10.1111\/dom.12403","article-title":"A 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In: The National Health and Nutrition Survey in Japan, 2017. 2018. https:\/\/www.mhlw.go.jp\/content\/000681194.pdf, Accessed 4 January 2021."},{"key":"pone.0248577.ref011","unstructured":"Japan Diabetes Clinical Data Management Study Group. http:\/\/jddm.jp\/data\/index-2018\/. Accessed 4 January, 2021."},{"key":"pone.0248577.ref012","doi-asserted-by":"crossref","first-page":"2073","DOI":"10.1080\/14656566.2016.1232395","article-title":"SGLT2 inhibitors in the pipeline for the treatment of diabetes mellitus in Japan","volume":"17","author":"H Ito","year":"2016","journal-title":"Expert Opin Pharmacother"},{"key":"pone.0248577.ref013","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1536\/ihj.54.93","article-title":"Trends in antidiabetic prescription patterns in Japan from 2005 to 2011","volume":"54","author":"T Kohro","year":"2013","journal-title":"Int Heart J"},{"key":"pone.0248577.ref014","first-page":"163","article-title":"Anagliptin in the treatment of type 2 diabetes: safety, efficacy, and patient acceptability","volume":"8","author":"S Nishio","year":"2015","journal-title":"Diabetes Metab Syndr Obes"},{"key":"pone.0248577.ref015","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1517\/14656566.2015.995091","article-title":"Comparison of 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Rosenstock","year":"2019","journal-title":"JAMA"},{"key":"pone.0248577.ref021","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1007\/s00125-012-2827-3","article-title":"Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis","volume":"56","author":"YG Kim","year":"2013","journal-title":"Diabetologia"},{"key":"pone.0248577.ref022","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1517\/14656566.2016.1145668","article-title":"Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study","volume":"17","author":"Y Terauchi","year":"2016","journal-title":"Expert Opin Pharmacother"},{"key":"pone.0248577.ref023","doi-asserted-by":"crossref","first-page":"1995","DOI":"10.1080\/14656566.2016.1219341","article-title":"Real-world evidence for the safety of ipragliflozin in elderly Japanese 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Yamanouchi","year":"2019","journal-title":"Diabetes Care"},{"key":"pone.0248577.ref029","doi-asserted-by":"crossref","first-page":"1161","DOI":"10.1093\/ndt\/gfp579","article-title":"High frequencies of diabetic micro- and macroangiopathies in patients with type 2 diabetes mellitus with decreased estimated glomerular filtration rate and normoalbuminuria","volume":"25","author":"H Ito","year":"2010","journal-title":"Nephrol Dial Transplant"},{"key":"pone.0248577.ref030","doi-asserted-by":"crossref","first-page":"1033","DOI":"10.1007\/s10157-020-01935-3","article-title":"The prognosis of subjects showing a reduced estimated glomerular filtration rate without albuminuria in Japanese patients with type 2 diabetes: a cohort study for diabetic kidney disease","volume":"24","author":"H Ito","year":"2020","journal-title":"Clin Exp Neprol"},{"key":"pone.0248577.ref031","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1016\/j.clinthera.2015.10.025","article-title":"Influence of Renal 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Samukawa","year":"2018","journal-title":"Clin Pharmacol Drug Dev"},{"key":"pone.0248577.ref034","doi-asserted-by":"crossref","first-page":"982","DOI":"10.1053\/j.ajkd.2008.12.034","article-title":"Revised equations for estimated GFR from serum creatinine in Japan","volume":"53","author":"S Matsuo","year":"2009","journal-title":"Am J Kidney Dis"},{"key":"pone.0248577.ref035","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1515\/CCLM.2001.106","article-title":"Evaluation of Aution Max AX-4280 automated urine test-strip analyser","volume":"39","author":"Z Zaman","year":"2001","journal-title":"Clin Chem Lab Med"},{"key":"pone.0248577.ref036","doi-asserted-by":"crossref","first-page":"330","DOI":"10.5414\/CN109188","article-title":"Association between chronic kidney disease and the cognitive function in subjects without overt dementia","volume":"89","author":"H Ito","year":"2018","journal-title":"Clin 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Ito","year":"2017","journal-title":"J Clin Med Res"},{"key":"pone.0248577.ref040","doi-asserted-by":"crossref","first-page":"1510","DOI":"10.1111\/jdi.13064","article-title":"Protective effect of sodium-glucose cotransporter 2 inhibitors in patients with rapid renal function decline, stage G3 or G4 chronic kidney disease and type 2 diabetes","volume":"10","author":"H Miyoshi","year":"2019","journal-title":"J Diabetes Investig"},{"key":"pone.0248577.ref041","doi-asserted-by":"crossref","first-page":"267","DOI":"10.14740\/jocmr3761","article-title":"Renoprotective Effects of additional SGLT2 inhibitor therapy in patients with type 2 diabetes mellitus and chronic kidney disease stages 3b-4: a real world report from a Japanese specialized diabetes care center","volume":"11","author":"S Sugiyama","year":"2019","journal-title":"J Clin Med Res"},{"key":"pone.0248577.ref042","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1186\/s13098-020-0516-9","article-title":"Impact of sodium-glucose cotransporter 2 inhibitors on renal function in participants with type 2 diabetes and chronic kidney disease with normoalbuminuria","volume":"12","author":"A Nakamura","year":"2020","journal-title":"Diabetol Metab Syndr"},{"key":"pone.0248577.ref043","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1016\/S0140-6736(99)12323-7","article-title":"Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy","volume":"355","author":"Heart Outcomes Prevention Evaluation Study Investigators","year":"2000","journal-title":"Lancet"},{"key":"pone.0248577.ref044","doi-asserted-by":"crossref","first-page":"861","DOI":"10.1056\/NEJMoa011161","article-title":"Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy","volume":"345","author":"BM Brenner","year":"2001","journal-title":"N Engl J 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