Patients with heart failure (HF) and a preserved (>40%) left ventricular ejection fraction (LVEF) have few therapeutic options. Sodium glucose cotransporter 2 inhibitors have been shown to reduce the risk of hospitalization for HF in patients with HF and a reduced LVEF. It is unknown if these drugs can provide a similar benefit for patients with HF with a preserved LVEF (HFpEF).
The phase 3 EMPEROR-Preserved trial (NCT03057951) evaluated the effect of sodium glucose cotransporter 2 inhibitor empagliflozin in patients with HFpEF. Investigators randomized 5988 adults with chronic HFpEF to take either 10 mg of empagliflozin daily (n=2997) or a placebo (n=2997) over a median of 26.2 months. The primary outcome was a composite of time to cardiovascular (CV) death or hospitalization for HF.
In the empagliflozin group, a primary outcome occurred in 415 (13.8%) participants, as compared with 511 (17.1%) in the placebo group (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.69-0.90; p<0.001). This effect was mostly due to a lower risk of hospitalization for HF in the empagliflozin group – 407 hospitalizations for HF occurred in the empagliflozin group, as compared with 541 in the placebo group (HR 0.73; 95% CI 0.61-0.88, p<0.001). The reduced risk of hospitalization or death seen in the empagliflozin group was maintained in patients regardless of the presence or absence of diabetes. In those with diabetes at baseline, the HR was .079 (95% CI 0.67-0.94), and in those without diabetes at baseline, the HR was 0.78 (95% CI 0.64-0.95). Empagliflozin did not significantly lower the risk for CV death alone.
Secondary outcomes of first and recurrent hospitalization for HF and estimated glomerular filtration rate also favoured empagliflozin.
The frequency of serious adverse events was similar between the two groups – 1436 events [47.9%] occurred with empagliflozin, and 1543 events [51.6%] with placebo. The most common adverse events experienced by those taking empagliflozin were uncomplicated genital and urinary tract infections and hypotension.
Researchers concluded that for patients with HFpEF, empagliflozin lowered the relative risk of CV death or hospitalization for HF by 21%.
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Author: Kelly Schoonderwoerd
Original article: Anker et al. N Engl J Med 2021 Oct 14; 385:1451-1464.
