Cardiovascular (CV) Benefit of Empagliflozin Across the Spectrum of CV Risk Factor Control in the EMPA-REG OUTCOME Trial.

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Control of multiple cardiovascular (CV) risk factors reduces CV events in individuals with type 2 diabetes (T2D).To investigate this association in a contemporary clinical trial population, including how CV risk factor control affects the CV benefits of empagliflozin, a sodium-glucose co-transporter-2 inhibitor.Post hoc analysis.Randomized CV outcomes trial (EMPA-REG OUTCOME).Empagliflozin or placebo.Risk of CV outcomes - including treatment effect of empagliflozin - by achievement of seven goals for CV risk factor control at baseline: glycated hemoglobin <7.5%, low-density lipoprotein cholesterol <100 mg/dL or statin use, systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, pharmacological renin-angiotensin-aldosterone system blockade, normoalbuminuria, aspirin use, non-smoking.In the placebo group, the hazard ratio (HR) for CV death was 4.00 (95% CI 2.26-7.11) and 2.48 (1.52-4.06) for patients achieving only 0-3 or 4-5 risk factor goals at baseline, respectively, compared to those achieving 6-7 goals. Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]). Empagliflozin significantly reduced these outcomes across all risk factor control categories (P>0.05 for treatment-by-subgroup interactions).CV risk in EMPA-REG OUTCOME was inversely associated with baseline CV risk factor control. Empagliflozin's cardioprotective effect was consistent regardless of multiple baseline risk factor control.

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