Key result
Empagliflozin meets primary clinical endpoint in HFpEF, but does not decrease all-cause mortality.
Why the study?
Previous HFpEF clinical trials have failed to meet their primary end points, raising questions about the appropriateness of all-cause mortality as an end point in this heterogeneous and older patient population.
Questions all-cause mortality as primary endpoint in HFpEF trials; leaves open optimal endpoint selection for future studies.
EMPEROR-PRESERVED, which examined sodium-glucose co-transporter 2 inhibitor empagliflozin, is the first study among patients with heart failure with preserved ejection fraction (HFpEF) to meet its primary end point.1 This is a major development for patients with HFpEF and the broader scientific community; all previous studies in HFpEF have failed to meet their primary end point. This includes the phase III clinical trials of sacubitril-valsartan and spironolactone, which served as the foundations for endorsement as treatment for HFpEF by the US Food and Drug Administration, despite failing to meet their prespecified primary end points.
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Goyal et al. (2022) conducted an editorial in Heart failure with preserved ejection fraction (HFpEF). Empagliflozin was evaluated. Empagliflozin is the first therapy to meet its primary clinical endpoint in patients with heart failure with preserved ejection fraction, although it did not decrease all-cause mortality.
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