{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T10:50:01Z","timestamp":1784544601219,"version":"3.55.0"},"reference-count":56,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2018,9,20]],"date-time":"2018-09-20T00:00:00Z","timestamp":1537401600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008349","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008349","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","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":[[2019,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>We investigated the safety and tolerability of empagliflozin (<jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content>) in East Asian patients with type 2 diabetes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>Data were pooled from participants with type 2 diabetes evenly randomized to a placebo, <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> 10 mg or <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> 25 mg in 15 phase I\u2013<jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> trials. Adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) were analyzed in the subgroup of trial participants from East Asian countries\/regions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 709, 724 and 708 East Asian trial participants with type 2 diabetes received a placebo, <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> 10 mg and <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> 25 mg, respectively; total exposure was 953, 1,072, and 1,033 patient\u2010years in these groups, respectively. The <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> and placebo groups had similar incidences of severe <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s and <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s leading to discontinuation. Incidences of hypoglycemia differed according to anti\u2010diabetes medication used at baseline. Higher rates of events consistent with genital infection were observed with <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> (<jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> 1.5\u20131.7\/100, placebo 0.2\/100 patient\u2010years). Rates of <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s consistent with volume depletion were comparable among treatment groups (0.8\u20131.4\/100 patient\u2010years), but in trial participants aged \u226565 years, the rate was greater with <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> 25 mg (<jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> 25 mg 3.5\/100, placebo 2.0\/100 patient\u2010years). Incidences of events consistent with urinary tract infection, thromboembolic events, renal events, hepatic <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, diabetic ketoacidosis, fractures and lower limb amputation were similar between <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> and the placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In the present pooled analysis, <jats:styled-content style=\"fixed-case\">EMPA<\/jats:styled-content> was well tolerated in East Asian type 2 diabetes patients based on &gt;2,100 patient\u2010years\u2019 exposure, consistent with results from the overall analysis population.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.12910","type":"journal-article","created":{"date-parts":[[2018,8,12]],"date-time":"2018-08-12T11:04:05Z","timestamp":1534071845000},"page":"418-428","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":36,"title":["Safety and tolerability of empagliflozin in East Asian patients with type 2 diabetes: Pooled analysis of phase I\u2013<scp>III<\/scp> clinical trials"],"prefix":"10.1111","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5334-7687","authenticated-orcid":false,"given":"Daisuke","family":"Yabe","sequence":"first","affiliation":[{"name":"Kansai Electric Power Medical Research Institute Kobe Japan"},{"name":"Kyoto University Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsutaka","family":"Yasui","sequence":"additional","affiliation":[{"name":"Nippon Boehringer Ingelheim Co., Ltd. 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