{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T07:53:22Z","timestamp":1773388402017,"version":"3.50.1"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T00:00:00Z","timestamp":1770595200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T00:00:00Z","timestamp":1770595200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabet Med"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To evaluate diabetic ketoacidosis (DKA) risk among new users of ertugliflozin versus sulfonylureas (SU) or thiazolidinediones (TZD) and incretin\u2010based drugs in patients with type 2 diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We used Medicare and Medicaid fee\u2010for\u2010service adjudicated claims within the Innovation in Medical Evidence and Development Surveillance network to identify three new\u2010user cohorts: (1) ertugliflozin; (2) SU\/TZD; and (3) incretin\u2010based drugs. The outcome was a principal hospital discharge diagnosis for DKA. Adjusted hazard ratios (HRs) were estimated after 1:1 propensity score (PS) matching, separately for ertugliflozin vs. SU\/TZD and vs. incretin\u2010based drugs. Subgroup analyses were performed based on baseline insulin use.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      After PS matching, baseline characteristics were similarly distributed in each cohort. For ertugliflozin (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200942,907) vs. SU\/TZD (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200942,907), the incidence rates of DKA per 1000 person\u2010years (PY) were 2.95 and 1.49, respectively. For ertugliflozin (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200942,247) vs. incretin\u2010based drugs (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200942,247), the incidence rates of DKA per 1000 PY were 2.76 and 1.06, respectively. For ertugliflozin vs. SU\/TZD, the HR [95% confidence interval (CI)] was 1.88 [1.17\u20133.02]; in non\u2010insulin users, 2.34 [1.27\u20134.31]; and in insulin users, 1.17 [0.54\u20132.52]. For ertugliflozin vs. incretin\u2010based drugs, the HR [95% CI] was 2.40 [1.40\u20134.11]; in non\u2010insulin users, 2.84 [1.42\u20135.66]; and in insulin users, 1.87 [0.79\u20134.46].\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Ertugliflozin was associated with a higher risk of DKA relative to comparators. HRs were higher among new users with no\u2010concomitant insulin use than those with concomitant insulin use. Results were consistent with prior SGLT2i data and highlighted the importance of caution by both patients and physicians.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dme.70208","type":"journal-article","created":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T18:39:38Z","timestamp":1770662378000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Post\u2010authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycaemic agents in a Medicare and Medicaid population"],"prefix":"10.1111","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7131-7580","authenticated-orcid":false,"given":"Ashish","family":"Rai","sequence":"first","affiliation":[{"name":"Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Marshall","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sampada","family":"Nandyala","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meg","family":"Her","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna A.","family":"Agan","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8896-6138","authenticated-orcid":false,"given":"Ting\u2010Ying","family":"Huang","sequence":"additional","affiliation":[{"name":"Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carla","family":"Rodriguez\u2010Watson","sequence":"additional","affiliation":[{"name":"Reagan\u2010Udall Foundation for the FDA  Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alecia","family":"Clary","sequence":"additional","affiliation":[{"name":"Evidence to Practice  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3725-3410","authenticated-orcid":false,"given":"Brandon","family":"Diessner","sequence":"additional","affiliation":[{"name":"Optum Life Sciences  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret B.","family":"Nolan","sequence":"additional","affiliation":[{"name":"HealthPartners Institute  Bloomington Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3378-0691","authenticated-orcid":false,"given":"Djeneba Audrey","family":"Djibo","sequence":"additional","affiliation":[{"name":"CVS Healthspire Payor and Life Sciences, LLC  Blue Bell Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"DeVries","sequence":"additional","affiliation":[{"name":"Humana Healthcare Research  Louisville Kentucky USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly","family":"Daniels","sequence":"additional","affiliation":[{"name":"Carelon Research, Inc  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiao","family":"Zhang","sequence":"additional","affiliation":[{"name":"Merck &amp; 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