{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T19:49:32Z","timestamp":1791575372477,"version":"4.3.4"},"reference-count":37,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2017,9,29]],"date-time":"2017-09-29T00:00:00Z","timestamp":1506643200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Metabolism Res"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Regulatory agencies have concluded that sodium glucose cotransporter 2 (SGLT2) inhibitors lead to ketoacidosis, but published literature on this point remains controversial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We searched the FDA Adverse Event Reporting System (FAERS) for reports of acidosis in patients treated with canagliflozin, dapagliflozin, or empagliflozin (from the date of each drug's FDA approval until May 15, 2015). We compared the number of SGLT2 inhibitor\u2010related reports to reports of acidosis in patients treated with the 2 most commonly used DPP4 inhibitors: sitagliptin and saxagliptin. We estimated relative risks of acidosis by relating the number of reports to cumulative drug sales (a surrogate for patient exposure).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>FAERS contained 259 reports of acidosis (including 192 reports of ketoacidosis) for SGLT2 inhibitors compared with 477 reports of acidosis for DPP4 inhibitors (including 71 reports of ketoacidosis). Based on estimated patient exposure, the overall risk of developing acidosis was ~14\u2010fold higher for SGLT2 inhibitors. Among 51 SGLT2 inhibitor\u2010related reports with quantifiable metabolic information, 20 cases occurred in patients with type 1 diabetes (T1D), 25 in type 2 diabetes (T2D), and 6 in patients with unspecified type of diabetes. After excluding patients with T1D and focusing on patients identified as having T2D, we estimate that SGLT2 inhibitors were associated with ~7\u2010fold increase in developing acidosis. Seventy\u2010one percent had euglycemic ketoacidosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our results support the FDA's warning that SGLT2 inhibitors lead to ketoacidosis, as evidenced by an increased reporting rate for acidosis above that in a comparator population treated with DPP4 inhibitors.<\/jats:p><\/jats:sec>","DOI":"10.1002\/dmrr.2924","type":"journal-article","created":{"date-parts":[[2017,7,24]],"date-time":"2017-07-24T07:06:39Z","timestamp":1500879999000},"source":"Crossref","is-referenced-by-count":227,"title":["Ketoacidosis associated with SGLT2 inhibitor treatment: Analysis of FAERS data"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6725-4262","authenticated-orcid":false,"given":"Jenny E.","family":"Blau","sequence":"first","affiliation":[{"name":"Diabetes, Endocrinology, and Obesity Branch, NIDDK  Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8878-1283","authenticated-orcid":false,"given":"Sri Harsha","family":"Tella","sequence":"additional","affiliation":[{"name":"Diabetes, Endocrinology, and Obesity Branch, NIDDK  Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7500-7854","authenticated-orcid":false,"given":"Simeon I.","family":"Taylor","sequence":"additional","affiliation":[{"name":"Diabetes, Endocrinology, and Obesity Branch, NIDDK  Bethesda MD USA"},{"name":"Division of Endocrinology, Diabetes, and Nutrition, Department of Medicine University of Maryland School of Medicine  Baltimore MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8421-131X","authenticated-orcid":false,"given":"Kristina I.","family":"Rother","sequence":"additional","affiliation":[{"name":"Diabetes, Endocrinology, and Obesity Branch, NIDDK  Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,9,29]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504720"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1611925"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1515920"},{"key":"e_1_2_6_5_1","unstructured":"AstraZeneca.Multicenter trial to evaluate the effect of Dapagliflozin on the incidence of cardiovascular events (DECLARE\u2010TIMI58). 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