{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:26:57Z","timestamp":1747186017247,"version":"3.40.5"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,3,15]],"date-time":"2020-03-15T00:00:00Z","timestamp":1584230400000},"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":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>Tofogliflozin is a potent and highly selective sodium\u2013glucose cotransporter\u00a02 inhibitor, and is currently used to treat patients with type\u00a02 diabetes mellitus. We designed a 3\u2010year study of tofogliflozin in patients with type\u00a02 diabetes mellitus to evaluate the safety and effectiveness in routine clinical practice. The 3\u2010 and 12\u2010month interim analysis showed tofogliflozin was well\u2010tolerated, safe and clinically effective. Here, we report the results of the 24\u2010month interim analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>This is a 3\u2010year prospective, observational and multicenter post\u2010marketing study (Japanese Study of Tofogliflozin with Type\u00a02 Diabetes Mellitus Patients\/Long Term).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 6,897 patients enrolled, 6,712 and 6,461 patients were analyzed for the safety and effectiveness of tofogliflozin, respectively. During the 24\u2010month observation period, the incidence rates of adverse drug reactions (ADRs) and serious adverse drug reactions were 11.25 and 1.21%, respectively. As to adverse drug reactions of special interest, the incidence rates of hypoglycemia, polyuria\/pollakiuria, volume depletion\u2010related events, urinary tract infections and genital infection were 0.83, 1.28, 1.46, 1.18 and 1.62%, respectively. Renal disorders, and cardiovascular and cerebrovascular disorders occurred in 0.63 and 0.76% of the patients, respectively. Glycated hemoglobin A1c and bodyweight decreased significantly by \u22120.70% (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001) and \u22122.95\u00a0kg (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.0001), respectively, from baseline to week 104 (last observation carried forward).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Significant safety concerns have not been observed, and clinical benefit including a long\u2010term reduction in glycated hemoglobin A1c over a 104\u2010week (24\u00a0months) observation period with weight loss was suggested in this 24\u2010month interim analysis of the 3\u2010year Japanese Study of Tofogliflozin with Type\u00a02 Diabetes Mellitus Patients\/Long Term in routine clinical practice.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.13233","type":"journal-article","created":{"date-parts":[[2020,2,8]],"date-time":"2020-02-08T14:28:48Z","timestamp":1581172128000},"page":"906-916","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Safety and effectiveness of tofogliflozin in Japanese patients with type\u00a02 diabetes mellitus: Results of 24\u2010month interim analysis of a long\u2010term post\u2010marketing study (J\u2010STEP\/LT)"],"prefix":"10.1111","volume":"11","author":[{"given":"Kazunori","family":"Utsunomiya","sequence":"first","affiliation":[{"name":"Center for Preventive Medicine The Jikei University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6673-1429","authenticated-orcid":false,"given":"Masayuki","family":"Senda","sequence":"additional","affiliation":[{"name":"Post Marketing Clinical Research Sanofi K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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":[{"role":"author","vocabulary":"crossref"}]},{"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":[{"role":"author","vocabulary":"crossref"}]},{"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":[{"role":"author","vocabulary":"crossref"}]},{"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":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Kameda","sequence":"additional","affiliation":[{"name":"Post Marketing Clinical Research Sanofi K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Tamura","sequence":"additional","affiliation":[{"name":"Post Marketing Clinical Research Sanofi K.K. 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