{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T18:54:32Z","timestamp":1789844072029,"version":"4.0.1"},"reference-count":50,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,8,25]],"date-time":"2020-08-25T00:00:00Z","timestamp":1598313600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>Tofogliflozin is a sodium\u2013glucose cotransporter\u00a02 (SGLT2) inhibitor that lowers plasma glucose levels by enhancing urinary glucose excretion. After its approval in Japan in 2014 for the treatment of type\u00a02 diabetes mellitus, we carried out a 3\u2010year prospective observational post\u2010marketing surveillance study in Japanese patients (Japanese Study of Tofogliflozin with Type\u00a02 Diabetes Mellitus Patients\/Long Term [J\u2010STEP\/LT]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>This surveillance was carried out between September 2014 and February 2019, and recorded safety in terms of adverse drug reactions (ADRs) and ADRs of special interest, and effectiveness in terms of changes in glycated hemoglobin and bodyweight from baseline to last observation carried forward.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 6,897 patients with type\u00a02 diabetes mellitus registered, 6,711 and 6,451 were analyzed for safety and effectiveness, respectively. ADRs were reported in 846 patients (12.61%), with serious ADRs in 101 patients (1.5%). ADRs of special interest included hypoglycemia (62 patients [0.9%]), polyuria\/pollakiuria (90 [1.3%]), volume depletion\u2010related disorders (135 [2.0%]), urinary tract infections (91 [1.4%]), genital infections (117 [1.7%]) and skin diseases (53 [0.8%]). One case of diabetic ketoacidosis was reported. The mean\u00a0\u00b1\u00a0standard deviation changes from baseline to last observation carried forward in glycated hemoglobin and bodyweight were \u22120.68\u00a0\u00b1\u00a01.34% (<jats:italic>n<\/jats:italic>\u00a0=\u00a06,158, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001) and \u22123.13\u00a0\u00b1\u00a04.67\u00a0kg (<jats:italic>n<\/jats:italic>\u00a0=\u00a05,213, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001), respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>J\u2010STEP\/LT, a 3\u2010year, prospective, observational, post\u2010marketing study in Japan, found no unprecedented ADRs, and consistent reductions from baseline in glycated hemoglobin and bodyweight over the observation period. The present results provide further evidence regarding the safety and tolerability of tofogliflozin in Japanese patients with type\u00a02 diabetes mellitus.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.13333","type":"journal-article","created":{"date-parts":[[2020,6,29]],"date-time":"2020-06-29T11:35:58Z","timestamp":1593430558000},"page":"184-199","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Safety and effectiveness of tofogliflozin in Japanese patients with type\u00a02 diabetes mellitus treated in real\u2010world clinical practice: Results of a 36\u2010month post\u2010marketing surveillance study (J\u2010STEP\/LT)"],"prefix":"10.1111","volume":"12","author":[{"given":"Kazunori","family":"Utsunomiya","sequence":"first","affiliation":[{"name":"Center for Preventive Medicine The Jikei University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4726-7282","authenticated-orcid":false,"given":"Ryusuke","family":"Koshida","sequence":"additional","affiliation":[{"name":"Medical Affairs Sanofi K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2293-1100","authenticated-orcid":false,"given":"Seigo","family":"Kakiuchi","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6673-1429","authenticated-orcid":false,"given":"Masayuki","family":"Senda","sequence":"additional","affiliation":[{"name":"Medical Affairs Sanofi K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6029-5643","authenticated-orcid":false,"given":"Shoko","family":"Fujii","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3464-0669","authenticated-orcid":false,"given":"Yuji","family":"Kurihara","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4241-9657","authenticated-orcid":false,"given":"Ryoji","family":"Gunji","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1574-0565","authenticated-orcid":false,"given":"Kohei","family":"Kaku","sequence":"additional","affiliation":[{"name":"Kawasaki Medical School Kurashiki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,8,25]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrneph.2016.170"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1812389"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504720"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611925"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.032038"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1811744"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1515920"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/dci18-0033"},{"key":"e_1_2_7_10_1","unstructured":"The Japan Diabetes Society.Treatment Guide for Diabetes 2016\u20132017 (English version). Available from:http:\/\/www.fa.kyorin.co.jp\/jds\/uploads\/Treatment_Guide_for_Diabetes_2016\u20102017.pdf. Accessed November 11 2019."},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-022577"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.13150"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12401"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-1251"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-0843"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-1380"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k4365"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.2903"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13424"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13115"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2018.10.019"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12957"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.13066"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13213"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2014.887680"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12626"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.13017"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.13097"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.13097"},{"key":"e_1_2_7_30_1","unstructured":"U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry.Diabetes Mellitus \u00ad\u2014 Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes 2008. Accessed March 9 2020. Withdrawn from the web March 9 2020."},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31184-X"},{"key":"e_1_2_7_32_1","unstructured":"MedDRA.Standardised MedDRA Queries (SMQs). How to use.Available from:https:\/\/www.meddra.org\/how\u2010to\u2010use\/tools\/smqs. Accessed March 9 2020."},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12933-015-0215-2"},{"key":"e_1_2_7_34_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2017.1408792"},{"key":"e_1_2_7_35_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2017.1392293"},{"key":"e_1_2_7_36_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2020.1694659"},{"key":"e_1_2_7_37_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0183235"},{"key":"e_1_2_7_38_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajprenal.00267.2015"},{"key":"e_1_2_7_39_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b5444"},{"key":"e_1_2_7_40_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.00800209"},{"key":"e_1_2_7_41_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2019-00286"},{"key":"e_1_2_7_42_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i3625"},{"key":"e_1_2_7_43_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13531"},{"key":"e_1_2_7_44_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2017.06.018"},{"key":"e_1_2_7_45_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13820"},{"key":"e_1_2_7_46_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2014.890925"},{"key":"e_1_2_7_47_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00592-018-1116-0"},{"key":"e_1_2_7_48_1","first-page":"e1","article-title":"Frequency of genital infections according to body mass index in dapagliflozin\u2010treated patients with type 2 diabetes mellitus","volume":"5","author":"Rudofsky G","year":"2017","journal-title":"Exp Clin Endocrinol Diabetes Rep"},{"key":"e_1_2_7_49_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2015.1055250"},{"key":"e_1_2_7_50_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(17)30327-3"},{"key":"e_1_2_7_51_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2011.03347.x"}],"container-title":["Journal of Diabetes Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjdi.13333","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdi.13333","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jdi.13333","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdi.13333","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,2]],"date-time":"2023-09-02T08:05:59Z","timestamp":1693641959000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdi.13333"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,25]]},"references-count":50,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,2]]}},"alternative-id":["10.1111\/jdi.13333"],"URL":"https:\/\/doi.org\/10.1111\/jdi.13333","archive":["Portico"],"relation":{},"ISSN":["2040-1116","2040-1124"],"issn-type":[{"value":"2040-1116","type":"print"},{"value":"2040-1124","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,25]]},"assertion":[{"value":"2020-03-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-06-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}