{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:09:18Z","timestamp":1787015358470,"version":"build-2736575974"},"reference-count":25,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,7,8]],"date-time":"2019-07-08T00:00:00Z","timestamp":1562544000000},"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":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims\/Introduction<\/jats:title>\n                    <jats:p>Due to the paucity of tofogliflozin data, we assessed the safety and effectiveness of tofogliflozin among Japanese patients with type\u00a02 diabetes mellitus in the clinical setting, stratifying the patients by age, sex, estimated glomerular filtration (eGFR) rate and body mass index. We report the results of a 12\u2010month interim analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>This was a 3\u2010year prospective, observational and multicenter post\u2010marketing study (Japanese Study of tofogliflozin with type\u00a02 diabetes mellitus Patients\/Long Term).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Out of 6,897 patients enrolled, the safety and effectiveness analysis populations consisted of 6,712 and 6,449 patients, respectively. During 12\u00a0months, adverse drug reactions and their incidence were 9.12 and 0.88%, respectively. The incidence of hypoglycemia was 0.67%. Polyuria\/pollakiuria occurred more frequently in patients aged \u226565\u00a0years than in patients aged &lt;65\u00a0years. Women experienced higher rates of urinary tract and genital infection than men. The lowest eGFR subgroup experienced maximum volume depletion\u2010related events. Cardiovascular and cerebrovascular disorders occurred in 0.55% of the patients. Glycated hemoglobin (HbA1c) and bodyweight significantly decreased by \u22120.76% and \u22122.73\u00a0kg, respectively, from baseline to the last observation carried forward (\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      &lt;\n                      <jats:italic>\u00a0<\/jats:italic>\n                      0.0001). Except for the lowest eGFR subgroup, other eGFR subgroups showed significantly decreased HbA1c values. All eGFR subgroups showed significantly decreased bodyweight, and all body mass index subgroups showed significantly decreased HbA1c and bodyweight.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our interim 12\u2010month data suggest that tofogliflozin could be used safely and effectively in Japanese patients with type\u00a02 diabetes mellitus, as tofogliflozin was well tolerated with low hypoglycemia risk, and significantly improved HbA1c and bodyweight.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jdi.13097","type":"journal-article","created":{"date-parts":[[2019,6,14]],"date-time":"2019-06-14T03:40:16Z","timestamp":1560483616000},"page":"132-141","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 in real\u2010world practice: Results of 12\u2010month interim analysis of a long\u2010term post\u2010marketing surveillance study (J\u2010STEP\/LT)"],"prefix":"10.1111","volume":"11","author":[{"given":"Kazunori","family":"Utsunomiya","sequence":"first","affiliation":[{"name":"Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine The Jikei University School of Medicine 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"}]},{"given":"Seigo","family":"Kakiuchi","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Kameda","sequence":"additional","affiliation":[{"name":"Medical Affairs Sanofi K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Tamura","sequence":"additional","affiliation":[{"name":"Medical Affairs Sanofi K.K. 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"}]},{"given":"Ryoji","family":"Gunji","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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\/0000-0003-1574-0565","authenticated-orcid":false,"given":"Kohei","family":"Kaku","sequence":"additional","affiliation":[{"name":"Department of Medicine Kawasaki Medical School Kurashiki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,8]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"Treatment Guide for Diabetes 2016\u20132017","author":"The Japan Diabetes Society","year":"2016"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000007201"},{"issue":"1","key":"e_1_2_7_4_1","first-page":"S73\u2013S85","article-title":"8. 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