BACKGROUND Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalization
for heart failure in patients with heart failure and a reduced ejection fraction,
but their effects in patients with heart failure and a preserved ejection fraction
are uncertain. METHODS In this double-blind trial, we randomly assigned 5988 patients
with class II-IV heart failure and an ejection fraction of more than 40% to receive
empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary
outcome was a composite of cardiovascular death or hospitalization for heart failure.
RESULTS Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997
patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in
the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90;
P<0.001). This effect was mainly related to a lower risk of hospitalization for heart
failure in the empagliflozin group. The effects of empagliflozin appeared consistent
in patients with or without diabetes. The total number of hospitalizations for heart
failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin
and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated
genital and urinary tract infections and hypotension were reported more frequently
with empagliflozin. CONCLUSIONS Empagliflozin reduced the combined risk of cardiovascular
death or hospitalization for heart failure in patients with heart failure and a preserved
ejection fraction, regardless of the presence or absence of diabetes.
