Introduction and Objective: Clinical trials were not powered to examine if the cardiovascular (CV) benefits of empagliflozin (EMPA) in patients with type 2 diabetes (T2D) are consistent across demographic factors.Methods: Using Medicare data (2014-2020), we compared 1:1 propensity score-matched patients aged ≥65 years with T2D initiating EMPA vs DPP4i for MACE, hospitalization for heart failure (HHF), and mortality, overall and by age, sex, and race or ethnicity, adjusting for 155 baseline confounders. We estimated rate differences (RD) and hazard ratios (HR) with 95% CI, assessing effect heterogeneity via the Wald test.Results: After PS matching, EMPA was associated with decreased risk of MACE [HR=0.77 (0.72, 0.81); RD= -10.10 (-12.38, -7.83)], HHF [HR=0.72 (0.69, 0.76); RD= -17.68 (-20.45, -14.91)], and mortality [HR=0.66 (0.60, 0.72); RD= -8.48 (-10.14, -6.82)] vs DPP4i, with evidence of effect heterogeneity seen only for age on the RD scale (Figure). Specifically, EMPA had greater absolute benefit vs DPP4i in patients aged ≥75 vs 65-74 years, with 17 vs 7 fewer MACE and 25 vs 14 fewer HHF events and 12 vs 6 fewer deaths per 1,000 person-years.Conclusion: This study suggests that EMPA is beneficial for CV events and mortality in subgroups of sex and race or ethnicity, though its absolute benefits vs DPP4i may vary by age, with a higher absolute benefit observed in older adults aged ≥75 vs 65-74 years.
S. Cromer: Other Relationship; Johnson & Johnson Medical Devices Companies. Advisory Panel; Alexion Pharmaceuticals, Inc. Consultant; Wolters Kluwer Health, Patient Square Capital. H. Tesfaye: None. D.J. Wexler: Other Relationship; Novo Nordisk. A. Freedman: None. C.M. Shay: Employee; Boehringer-Ingelheim. J.M. Paik: None. E. Patorno: Research Support; National Institute of Diabetes and Digestive and Kidney Diseases, Patient-Centered Outcomes Research Institute, Food and Drug Administration (FDA), Boehringer-Ingelheim. Other Relationship; UpToDate.
American Diabetes Association (7-21-JDFM-005); This study was supported by a research grant to the Brigham and Women’s Hospital from Boehringer Ingelheim. Boehringer Ingelheim had no role in the design, analysis, or interpretation of the results in this study. Boehringer Ingelheim was given the opportunity to review the abstract for medical and scientific accuracy as it relates to Boehringer Ingelheim substances, as well as intellectual property considerations.
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