{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T17:58:56Z","timestamp":1770487136712,"version":"3.49.0"},"reference-count":17,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2016,4,24]],"date-time":"2016-04-24T00:00:00Z","timestamp":1461456000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Kowa company, Ltd."},{"name":"Sanofi K. K."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>Sodium\u2010glucose co\u2010transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1\u2010year post\u2010marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12\u2010week interim analysis, focusing on adverse drug reactions of special interest.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>The present prospective observational study included all type 2 diabetes mellitus patients aged \u226565 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow\u2010up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria\/pollakiuria, volume depletion\u2010related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; <jats:italic>P<\/jats:italic> &lt; 0.0001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This interim analysis characterized the safety profile of tofogliflozin in Japanese elderly patients with type 2 diabetes mellitus during the early post\u2010marketing period.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.12513","type":"journal-article","created":{"date-parts":[[2016,3,3]],"date-time":"2016-03-03T07:48:45Z","timestamp":1456991325000},"page":"755-763","source":"Crossref","is-referenced-by-count":8,"title":["Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J\u2010<scp>STEP<\/scp>\/<scp>EL<\/scp>): A 12\u2010week interim analysis"],"prefix":"10.1111","volume":"7","author":[{"given":"Kazunori","family":"Utsunomiya","sequence":"first","affiliation":[{"name":"Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine Jikei University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoki","family":"Shimmoto","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masayuki","family":"Senda","sequence":"additional","affiliation":[{"name":"Post Marketing Clinical Research Sanofi K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Kurihara","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryoji","family":"Gunji","sequence":"additional","affiliation":[{"name":"Post Marketing Surveillance Department Kowa Company, Ltd. 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. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanako","family":"Mihara","sequence":"additional","affiliation":[{"name":"Medical Affairs Sanofi K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kohei","family":"Kaku","sequence":"additional","affiliation":[{"name":"Department of General Internal Medicine 1 Kawasaki Medical School Kurashiki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,4,24]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Ministry of Health Labour and Welfare Japan.The National Health and Nutrition SurveyJapan2012. Available from:http:\/\/www.mhlw.go.jp\/stf\/houdou\/0000032074.htmlAccessed October 17 2015 (in Japanese)."},{"key":"e_1_2_7_3_1","volume-title":"Treatment Guide for Diabetes 2014\u20132015","author":"Japan Diabetic Society","year":"2014"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2011.01511.x"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2010.512"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-014-0229-1"},{"key":"e_1_2_7_7_1","unstructured":"Committee on Proper Use of SGLT2 Inhibitors.Recommendations on the proper use of SGLT2 inhibitors.2014(in Japanese)."},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1358\/dot.2014.50.11.2232267"},{"key":"e_1_2_7_9_1","unstructured":"Japan Pharmaceutical Manufacturers Association.A guide for preparing risk management plans for drug products (provisional). 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Accessed October 17 2015."},{"key":"e_1_2_7_13_1","unstructured":"Kowa Company Ltd.Package insert for Deberza 20 mg Tablet(in Japanese)"},{"key":"e_1_2_7_14_1","unstructured":"SanofiKKPackage insert for Apleway 20 mg Tablet(in Japanese)."},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2014.887680"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2011.01359.x"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.466"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2013.356"}],"container-title":["Journal of Diabetes Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjdi.12513","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdi.12513","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jdi.12513","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdi.12513","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,2]],"date-time":"2023-10-02T12:21:29Z","timestamp":1696249289000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdi.12513"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,4,24]]},"references-count":17,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2016,9]]}},"alternative-id":["10.1111\/jdi.12513"],"URL":"https:\/\/doi.org\/10.1111\/jdi.12513","archive":["Portico"],"relation":{},"ISSN":["2040-1116","2040-1124"],"issn-type":[{"value":"2040-1116","type":"print"},{"value":"2040-1124","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,4,24]]}}}