{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T15:49:54Z","timestamp":1792511394858,"version":"4.5.0"},"reference-count":54,"publisher":"American Medical Association (AMA)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Intern Med"],"published-print":{"date-parts":[[2023,3,1]]},"abstract":"<jats:sec id=\"ab-ioi220086-4\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>\n                      Sodium-glucose cotransporter 2 inhibitor (SGLT2i) therapy has been associated with cardiovascular benefits and a few adverse events; however, whether the comparative effectiveness and safety profiles vary with differences in baseline hemoglobin A\n                      <jats:sub>1c<\/jats:sub>\n                      (HbA\n                      <jats:sub>1c<\/jats:sub>\n                      ) levels is unknown.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ioi220086-5\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To compare cardiovascular effectiveness and safety of treatment with SGLT2i vs dipeptidyl peptidase 4 inhibitor (DPP-4i) in adults with type 2 diabetes (T2D) (1) overall and (2) at varying baseline HbA\n                      <jats:sub>1c<\/jats:sub>\n                      levels.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ioi220086-6\">\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>\n                      A new-user comparative effectiveness and safety research study was conducted among 144\u202f614 commercially insured adults, initiating treatment with SGLT2i or DPP-4i and with a recorded T2D diagnosis at baseline and at least 1 HbA\n                      <jats:sub>1c<\/jats:sub>\n                      laboratory result recorded within 3 months before treatment initiation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ioi220086-7\">\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>The intervention consisted of the initiation of treatment with SGLT2i or DPP-4i.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ioi220086-8\">\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>Primary outcomes were a composite of myocardial infarction, stroke, or all-cause death (modified major adverse cardiovascular events [MACE]) and hospitalization for heart failure (HHF). Safety outcomes were hypovolemia, fractures, falls, genital infections, diabetic ketoacidosis (DKA), acute kidney injury (AKI), and lower-limb amputation. Incidence rate (IR) per 1000 person-years, hazard ratios (HR) and rate differences (RD) with their 95% CIs were estimated controlling for 128 covariates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ioi220086-9\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 144\u202f614 eligible adults (mean [SD] age, 62 [12.4] years; 54% male participants) with T2D initiating treatment with a SGLT2i (n\u2009=\u200960\u202f523) or a DPP-4i (n\u2009=\u200984\u202f091) were identified; 44\u202f099 had an HbA\n                      <jats:sub>1c<\/jats:sub>\n                      baseline value of less than 7.5%, 52\u202f986 between 7.5% and 9%, and 47\u202f529 greater than 9%. Overall, 87\u202f274 eligible patients were 1:1 propensity score\u2013matched: 24\u202f052 with HbA\n                      <jats:sub>1c<\/jats:sub>\n                      less than 7.5%; 32\u202f290 with HbA\n                      <jats:sub>1c<\/jats:sub>\n                      between 7.5% and 9%; and 30\u202f932 with HbA\n                      <jats:sub>1c<\/jats:sub>\n                      greater than 9% (to convert percentage of total hemoglobin to proportion of total hemoglobin, multiply by 0.01). The initiation of SGLT2i vs DPP-4i was associated with a reduction in the risk of modified MACE (IR per 1000 person-years 17.13 vs 20.18, respectively; HR, 0.85; 95% CI, 0.75-0.95; RD, \u22123.02; 95% CI, \u22125.23 to \u20130.80) and HHF (IR per 1000 person-years 3.68 vs 8.08, respectively; HR, 0.46; 95% CI, 0.35 to 0.57; RD \u22124.37; 95% CI, \u22125.62 to \u22123.12) over a mean follow-up of 8 months, with no evidence of treatment effect heterogeneity across the HbA\n                      <jats:sub>1c<\/jats:sub>\n                      levels. Treatment with SGLT2i showed an increased risk of genital infections and DKA and a reduced AKI risk compared with DPP-4i. Findings were consistent by HbA\n                      <jats:sub>1c<\/jats:sub>\n                      levels, except for a more pronounced risk of genital infections associated with SGLT2i for HbA\n                      <jats:sub>1c<\/jats:sub>\n                      levels of 7.5% to 9% (IR per 1000 person-years 68.5 vs 22.8, respectively; HR, 3.10; 95% CI, 2.68-3.58; RD, 46.22; 95% CI, 40.54-51.90).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ioi220086-10\">\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>\n                      In this comparative effectiveness and safety research study among adults with T2D, SGLT2i vs DPP-4i treatment initiators had a reduced risk of modified MACE and HHF, an increased risk of genital infections and DKA, and a lower risk of AKI, regardless of baseline HbA\n                      <jats:sub>1c<\/jats:sub>\n                      .\n           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