The EMPA-REG study: What has it told us? A diabetologist’s perspective
Abstract
EMPA-REG (Zinman et al., 2015) is the first study to conclusively demonstrate that a medication developed to reduce glycemia (Abdul-Ghani, Norton, & DeFronzo, 2011) in patients with type 2 diabetes mellitus (T2DM) decreases cardiovascular events. In 7020 T2DM patients with established cardiovascular (CV) disease, empagliflozin (pooled 10 and 25 mg/day doses) significantly reduced the primary MACE outcome (cardiovascular death, nonfatal MI, nonfatal stroke) by 14% compared to placebo (HR = 0.86, 95% CI = 0.74–0.99, P = 0.04 for superiority). It is noteworthy that a striking disconnect was observed between the three MACE components; (i) for nonfatal MI, the HR (= 0.87) decreased slightly but not significantly (P = 0.22); (ii) for stroke, the HR (=1.24) increased slightly but not significantly (P = 0.22); (iii) for cardiovascular death, the HR (=0.62) decreased significantly by 38% (p < 0.001). The reduction in CV death (5.9% to 3.6%, p < 0.001) was observed across all diagnostic categories (sudden death, 1.6% to 1.1%; worsening heart failure, 0.8% to 0.2%; acute MI, 0.5% to 0.3%; stroke, 0.5% to 0.3%; “other cardiovascular death”, 2.4% to 1.6%). The latter category includes deaths that cannot be explained by any other known cause. The majority of such cases have been shown to result from acute MI or, less commonly, arrhythmias and this category is not as diagnostically sound as the others. Other
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