EMPEROR-Preserved 2021 (Empagliflozin in HFpEF)

 Empagliflozin is better than placebo in improving HF outcomes among patients with symptomatic stable HFpEF on good baseline GDMT, regardless of diabetes status, according to the EMPEROR-Preserved study.


The trial's purpose was to see if empagliflozin was safe and effective in patients with symptomatic heart failure with preserved ejection fraction (HFpEF), regardless of diabetes.


Design of the Study:


Patients were randomly assigned to either empagliflozin 10 mg (n = 2,997) or a placebo (n = 2,991) in a 1:1 ratio. Geographic location, diabetes status, estimated glomerular filtration rate (eGFR), and left ventricular ejection fraction were all used to stratify the experiment (LVEF: more or less than 50 percent ). All of the patients were being treated for heart failure.


11,583 people were screened in total.

The total number of students enrolled is 5,988.

Follow-up period: 26.2 months (median)

The average patient is 72 years old.

45 percent of the population is female.




The major outcome, cardiovascular (CV) death or HF hospitalization, was 13.8 percent vs. 17.1 percent for empagliflozin vs. placebo (hazard ratio [HR] 0.79, 95 percent confidence interval [CI] 0.69-0.90, p 0.001).


Death from cardiovascular disease (CVD): 7.3 percent vs. 8.2 percent (HR 0.91, 95 percent CI 0.76-1.09)


Hospitalization for HF: 8.6% vs. 11.8 percent (HR 0.71, 95 percent CI 0.60-0.83)


The advantage was equivalent in persons with and without type 2 diabetes for the primary outcome. The advantage appeared to be diminished in patients with an EF greater than 60%.


Secondary outcomes compared to placebo for empagliflozin:


  • Hospitalizations total: 407 vs. 541 (p 0.001).
  • -1.25 vs. -2.62 (p 0.001) change in mean eGFR slope/year
  • 3.6 percent vs. 3.7 percent (p > 0.05) composite renal outcome
  • 13.4 percent vs. 14.2 percent all-cause mortality (HR 0.92, 95 percent CI 0.77-1.10, p > 0.05)
  • 12.0% vs. 14.0 percent (p > 0.05) of patients with prediabetes develop type 2 diabetes.


In 2021, this is likely to be the most practice-changing trial. It backed up the findings of the SOLOIST-WHF and SCORED studies in patients with heart failure and preserved ejection fraction (HFpEF). Importantly, EMPEROR-Preserved extended those findings to non-diabetic patients.


Find this trial in NEJM

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