{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T04:02:44Z","timestamp":1784520164288,"version":"3.55.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,12,25]],"date-time":"2025-12-25T00:00:00Z","timestamp":1766620800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,12,25]],"date-time":"2025-12-25T00:00:00Z","timestamp":1766620800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Diabetic ketoacidosis (DKA) is an important identified risk of treatment with the sodium\u2010glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin, particularly in patients with type 1 diabetes mellitus (T1DM). We evaluated the DKA incidence rate (IR) among dapagliflozin\u2010treated Japanese patients with T1DM receiving concomitant insulin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This observational, cohort, post\u2010marketing study utilized data from the JMDC Payer database. All patients had T1DM and were prescribed insulin; the dapagliflozin group included dapagliflozin\u2010treated patients and the control group included SGLT2i nonusers. The study outcomes were DKA events (a composite of DKA resulting in hospitalization and\/or death). Using a prevalent new\u2010user design, time\u2010stratified sequential propensity score (PS) matching was implemented.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Between March 2019 and March 2021, 5886 insulin\u2010treated patients with T1DM were eligible, and 327\/5886 patients newly received dapagliflozin. After up to 1:3 PS\u2010matching, 327 dapagliflozin\u2010treated patients and 980 matched controls were analyzed. The IRs (95% confidence interval) of DKA in the PS\u2010matched cohort were 1.54 per 100 person\u2010years (\/100 PY; 0.42\u20133.95) and 1.14\/100 PY (0.55\u20132.10) in the dapagliflozin and control groups, respectively, with a hazard ratio of 1.28 (0.40\u20134.09). The IRs in the unmatched cohort were 1.54\/100 PY (0.42\u20133.95) and 0.97\/100 PY (0.72\u20131.27) in the dapagliflozin and control groups, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>DKA incidence in dapagliflozin\u2010treated T1DM patients was slightly higher than in SGLT2i nonusers. As the confidence intervals overlapped, these results did not suggest any meaningful differences or unexpected higher risk of DKA, consistent with previous reports in other countries.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70294","type":"journal-article","created":{"date-parts":[[2025,12,26]],"date-time":"2025-12-26T06:21:13Z","timestamp":1766730073000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Incidence of Diabetic Ketoacidosis in Dapagliflozin\u2010Treated Japanese Patients With Type 1 Diabetes Mellitus: An Observational Cohort Database Study"],"prefix":"10.1002","volume":"35","author":[{"given":"Reiko","family":"Tamura","sequence":"first","affiliation":[{"name":"Japan Patient Safety AstraZeneca K.K.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyosung","family":"Kim","sequence":"additional","affiliation":[{"name":"Research &amp; Development AstraZeneca K.K.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Takumi","sequence":"additional","affiliation":[{"name":"Japan Patient Safety AstraZeneca K.K.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miyo","family":"Ishihara","sequence":"additional","affiliation":[{"name":"Japan Patient Safety AstraZeneca K.K.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8533-3052","authenticated-orcid":false,"given":"Tomoko","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Evidence Observational Research AstraZeneca K.K.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Layton","sequence":"additional","affiliation":[{"name":"Safety Epidemiology AstraZeneca Ltd.  Cambridge UK"},{"name":"PEPI Consultancy Ltd.  Southampton UK"},{"name":"University of Hertfordshire  Hatfield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kei","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Japan Patient Safety AstraZeneca K.K.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,25]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213\u20108587(22)00218\u20102"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41574\u2010019\u20100254\u2010y"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/1179551419844521"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41574\u2010021\u201000542\u2010w"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd3180"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15\u20100279"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00045.2011"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000441\u2010200605000\u201000002"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.metabol.2015.12.007"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc09\u20109032"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15\u20100843"},{"key":"e_1_2_10_13_1","unstructured":"AstraZeneca \u201cForxiga Receives Regulatory Approval in Japan for the Treatment of Type 2 Diabetes \u201d2014 https:\/\/www.astrazeneca.com\/media\u2010centre\/press\u2010releases\/2014\/forxiga\u2010approval\u2010japan\u2010type\u20102\u2010diabetes\u2010treatment\u201024032014.html."},{"key":"e_1_2_10_14_1","unstructured":"AstraZeneca \u201cForxiga Approved in Japan for Type\u20101 Diabetes \u201d2019 https:\/\/www.astrazeneca.com\/media\u2010centre\/press\u2010releases\/2019\/forxiga\u2010approved\u2010in\u2010japan\u2010for\u2010type\u20101\u2010diabetes\u201027032019.html."},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14248"},{"key":"e_1_2_10_16_1","unstructured":"PMDA \u201cDapagliflozin Risk Management Plan [Japanese] \u201daccessed February 13 2025 https:\/\/www.pmda.go.jp\/RMP\/www\/670227\/8584b150\u20100d8a\u20104443\u2010910e\u2010a5e8509fcdd1\/670227_3969019F1027_014RMP.pdf."},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4107"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18\u20101160"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.2307\/2290085"},{"key":"e_1_2_10_20_1","volume-title":"Performing a 1:N Case\u2010Control Match on Propensity Score","author":"Parsons L. 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