EMPEROR-Preserved Clinical Trial Review

EMPEROR-Preserved Clinical Trial Review

EMPEROR-Preserved Clinical Trial is an important study which has shown benefit in patients with heart failure and a preserved ejection fraction (HFpEF) [1].
It was a double blind randomized trial in which 5988 patients with class II-IV heart failure and ejection fraction above 40% were allocated to receive empagliflozin 10 mg daily or placebo, in addition to usual therapy.
The median ejection fraction noted in the study patients was 54%, with two thirds of patients having a left ventricular ejection fraction of 50% or more.
Primary outcome measure in the study was a composite of cardiovascular death or hospitalization for heart failure.
The median follow-up period was 26.2 months. Primary outcome event occurred in 415 of those on empagliflozin and 511 in the placebo group. This was mainly due to the lower risk of hospitalization for heart failure in the empagliflozin group.
The effect appeared to be similar in those with and without diabetes mellitus. Total number of hospitalization was 407 in empagliflozin group and 541 with placebo (P<0.001).
As expected, uncomplicated genital and urinary tract infections and hypotension were more frequently reported in the empagliflozin group.
In summary, SGLT2 inhibition with empagliflozin led to a 21% lower relative risk of the composite end point of cardiovascular death or hospitalization. Reduction in risk of hospitalization for heart failure was 29%.
The results are similar to that of EMPEROR-Reduced in patients with heart failure and reduced ejection fraction [2].
It is noteworthy that previous large scale trials of medications in patients with heart failure and preserved ejection fraction failed to show significant overall benefit.

References

  1. Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Böhm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Piña IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Aug 27. doi: 10.1056/NEJMoa2107038. Epub ahead of print. PMID: 34449189.
  2. Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Böhm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28. PMID: 32865377.