{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T17:54:23Z","timestamp":1792086863054,"version":"4.4.0"},"reference-count":23,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T00:00:00Z","timestamp":1723593600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015993","name":"Kowa Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015993","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>Sodium\u2013glucose cotransporter\u20092 (SGLT2) inhibitors effectively and safely reduce fasting and postprandial hyperglycemia while promoting weight loss. However, their unique mechanism of action contributes to concerns regarding their safety. We therefore carried out a large\u2010scale, non\u2010commercial, investigator\u2010initiated study on the safety and effectiveness of the SGLT2 inhibitor tofogliflozin.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>This multicenter, open\u2010label, uncontrolled, prospective observational study was carried out at hospitals and clinics across Japan in participants aged \u226520\u2009years who were SGLT2 inhibitor\u2010na\u00efve and had an established diagnosis of type\u20092 diabetes. The primary endpoint was adverse drug reactions (ADRs) of special interest. Secondary endpoints included all other ADRs and adverse events, glycated hemoglobin (HbA1c), and weight loss.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The study, carried out from June 2014 through February 2020, enrolled 11,480 participants from 1,103 medical institutions; 6,967 participants completed the 104\u2010week follow up. The most common ADRs of special interest were urinary and genital tract infections (1.53%), followed by volume depletion (1.25%). Hypoglycemia occurred in 27 participants (0.24%), adverse events in 1,054 (9.18%) and ADRs in 645 (5.62%). HbA1c decreased by 0.85% (95% confidence interval 0.82%\u20130.88%) and bodyweight decreased by 3.05\u2009kg (95% confidence interval 2.94\u20133.17\u2009kg). The HbA1c target was achieved by 51.70% of participants for target HbA1c &lt;7.0%, 85.3% for &lt;8.0% and 5.4% for &lt;6.0% at week\u2009104.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Tofogliflozin was associated with only mild or moderate ADRs characteristic of SGLT2 inhibitors, with no unpredictable, new, serious, or high\u2010incidence adverse events or ADRs. This independent study confirmed the safety and effectiveness of tofogliflozin in adult type\u20092 diabetes patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.14287","type":"journal-article","created":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T15:39:46Z","timestamp":1723649986000},"page":"1585-1595","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Safety and effectiveness of tofogliflozin in Japanese people with type\u20092 diabetes: A multicenter prospective observational study in routine clinical practice"],"prefix":"10.1111","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1623-0815","authenticated-orcid":false,"given":"Yuichiro","family":"Yamada","sequence":"first","affiliation":[{"name":"Japan Association for Diabetes Education and Care  Tokyo Japan"},{"name":"Yutaka Seino Distinguished Center for Diabetes Research Kansai Electric Power Medical Research Institute  Kyoto Japan"},{"name":"Kansai Electric Power Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5334-7687","authenticated-orcid":false,"given":"Daisuke","family":"Yabe","sequence":"additional","affiliation":[{"name":"Japan Association for Diabetes Education and Care  Tokyo Japan"},{"name":"Yutaka Seino Distinguished Center for Diabetes Research Kansai Electric Power Medical Research Institute  Kyoto Japan"},{"name":"Department of Diabetes, Endocrinology and Metabolism and Department of Rheumatology and Clinical Immunology Gifu University Graduate School of Medicine  Gifu Japan"},{"name":"Center for One Medicine Innovative Translational Research Gifu University  Gifu Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichiro","family":"Shide","sequence":"additional","affiliation":[{"name":"Japan Association for Diabetes Education and Care  Tokyo Japan"},{"name":"Department of Metabolism and Clinical Nutrition Kyoto University Hospital  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Japan Association for Diabetes Education and Care  Tokyo Japan"},{"name":"Department of Endocrinology, Diabetes and Metabolism Fujita Health University  Toyoake Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuo","family":"Terauchi","sequence":"additional","affiliation":[{"name":"Japan Association for Diabetes Education and Care  Tokyo Japan"},{"name":"Department of Endocrinology and Metabolism Yokohama City University Graduate School of Medicine  Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasunori","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Preventive Medicine and Public Health Keio University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuyuki","family":"Shihara","sequence":"additional","affiliation":[{"name":"Japan Association for Diabetes Education and Care  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1099-7989","authenticated-orcid":false,"given":"Yutaka","family":"Seino","sequence":"additional","affiliation":[{"name":"Japan Association for Diabetes Education and Care  Tokyo Japan"},{"name":"Yutaka Seino Distinguished Center for Diabetes Research Kansai Electric Power Medical Research Institute  Kyoto Japan"},{"name":"Kansai Electric Power Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,8,14]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Japan Diabetes Clinical Data Management Study Group.Basic study data in 2021. Available from:http:\/\/jddm.jp\/public\u2010information\/index\u20102021\/. Accessed November 9 2023."},{"key":"e_1_2_7_3_1","volume-title":"Oral Diabetes Medications for Adults with Type 2 Diabetes: An Update. Effective Health Care Program: Comparative Effectiveness Review","author":"Bennett WL","year":"2011"},{"key":"e_1_2_7_4_1","volume-title":"Treatment Guide for Diabetes 2022\u20132023","author":"The Japan Diabetes Society","year":"2022"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/dci22-0034"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-physiol-031620-095920"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrneph.2016.170"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2020.1817388"},{"key":"e_1_2_7_9_1","first-page":"1305","article-title":"Evaluation of safety and efficacy of dapagliflozin in patients with type 2 diabetes: A final report of a special drug use\u2013results survey for long\u2010term use (DAHLIA study)","volume":"48","author":"Hara H","year":"2020","journal-title":"Jpn Pharmacol Ther"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-021-01984-4"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2022.2054987"},{"key":"e_1_2_7_12_1","unstructured":"Committee on proper use of SGLT2 inhibitors.Recommendations for proper use of SGLT2 inhibitors in the treatment of diabetes. 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