Abstract
The EMPA-REG OUTCOME trial reported cardioprotective effects of empagliflozin (EMPA) in patients with established cardiovascular diseases (CVD). We evaluated the association between EMPA and the risk of cardiovascular events, versus GLP1 receptor agonist (GLP-1RA) or DPP4 inhibitor (DPP-4i) in the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) study of type 2 diabetes (T2D) patients in routine care, updating a prior analysis using data from 08/2014 through 09/2018. Using 2 commercial and Medicare claims databases, we identified 88,826 pairs of 1:1 propensity score-matched (PSM) T2D patients ≥18 years initiating EMPA or a GLP-1RA [Cohort 1], and 69,610 pairs initiating EMPA or a DPP-4i [Cohort 2]. Our outcomes were (i) a composite of atherosclerotic cardiovascular diseases (ASCVD): MI, stroke, unstable angina and coronary revascularization and (ii) heart failure hospitalization in primary discharge (HHF-Primary) or any position (HHF-Any). In each cohort, we estimated hazard ratios (HR) and 1-year numbers needed to treat (NNT), accounting for death as a competing risk, pooled across databases adjusting for >140 baseline covariates. After PSM, exposure groups had similar characteristics (Table 1). Compared to GLP-1RA, EMPA had a similar risk of ASCVD [HR (95% CI): 1.05 (0.96,1.15)] and a decreased risk of HHF-Primary: 0.64 (0.54,0.76) and HHF-Any: 0.83 (0.77,0.90). One-year NNTs for EMPA vs GLP-1RA were 235 for HHF-Primary and 133 for HHF-Any. Results for EMPA vs DPP-4i were similar: ASCVD [0.94 (0.85,1.03)], HHF-Primary [0.46 (0.38,0.55)] and HHF-Any [0.66 (0.60,0.72)]. One-year NNTs for EMPA vs DPP-4i were 100 for HHF-Primary and 52 for HHF-any. Results for the individual components of the ASCVD outcome were consistent. The updated analysis from EMPRISE showed that relative to GLP-1RA or DPP-4i, EMPA was associated with a similar risk of ASCVD and a reduced risk of HHF in routine care, with more precise estimates compared to prior analyses.
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