P002. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

Abstract

<h3>Background</h3> Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalizations for heart failure in patients with or without diabetes. More evidence is needed regarding their effects across the broad spectrum of heart failure, including those with reduced ejection fraction (HFrEF). <h3>Methods</h3> We randomly assigned, in double-blind fashion, 3730 patients with class II-IV heart failure and left ventricular ejection fraction ≤40% to receive empagliflozin (10 mg once daily) or placebo, in addition to standard therapy for HFrEF. The primary outcome was a composite of cardiovascular death and hospitalization for worsening heart failure. <h3>Results</h3> Over a median of 16 months, the primary outcome occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio 0.75; 95% CI: 0.65-0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of diabetes status. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio 0.70; 95% CI: 0.58-0.85; P<0.001). The rate of decline in estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs -2.28 ml/min/1.73m²/year), P<0.001, and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infections were reported more frequently with empagliflozin. <h3>Conclusions</h3> Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure, regardless of the presence or absence of diabetes.