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EMPEROR-Preserved trial results published in The New England Journal of Medicine in 20211

A randomised, double blind, parallel group, placebo controlled, event driven trial

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5988

patients with LVEF > 40%

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23

countries

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26.2 months

(median observation)

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926

events observed

Prespecified efficacy endpoints

  • Composite primary endpoint:  Time to first event of adjudicated CV death or adjudicated HHF

  • Confirmatory secondary endpoints: Total number of HHF, including first and recurrent; rate of decline in eGFR from baseline

Key inclusion criteria

  • Chronic heart failure (NYHA class II-IV)

  • Elevated NT proBNP and structural heart changes or documented HHF within 12 months*

  1. Anker SD, Butler J, Filippatos G, et al; EMPEROR Preserved Trial Investigators. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451-1461. doi:10.1056/NEJMoa2107038 (EMPEROR-Preserved results and the publication's Supplementary Appendix.)

  • *
    Defined as a level of > 300 pg /mL or, for patients with atrial fibrillation at baseline, a level of > 900 pg /mL.1
  • †
    Background therapy: All appropriate treatments for heart failure or comorbid conditions could be initiated or altered at
    the discretion of the clinician.1
  • ‡
    Numbers shown are for the JARDIANCE arm.1
  • ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin II receptor blocker; ARNI=angiotensin receptor neprilysin inhibitor; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HHF= hospitalisation for heart failure; LVEF=left ventricular ejection fraction; MRA=mineralocorticoid receptor antagonist; NT proBNP =N terminal pro brain natriuretic peptide; NYHA=New York Heart Association; T2D=type 2 diabetes.

EMPEROR Preserved trial results published in The New England Journal of Medicine in 20211

Patient characteristics

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Background therapy for heart failure included beta blockers (86%), ACEIs/ARBs (79%), MRAs (38%), and ARNIs (2%)†‡
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  1. Anker SD, Butler J, Filippatos G, et al; EMPEROR-Preserved Trial Investigators. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451-1461. doi:10.1056/NEJMoa2107038 (EMPEROR-Preserved results and the publication's Supplementary Appendix.)

  • *
    Defined as a level of > 300 pg/mL or, for patients with atrial fibrillation at baseline, a level of >900 pg/mL.1
  • †
    Background therapy: All appropriate treatments for heart failure or comorbid conditions could be initiated or altered at
    the discretion of the clinician.1
  • ‡
    Numbers shown are for the JARDIANCE arm.1
  • ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin II receptor blocker; ARNI=angiotensin receptor neprilysin inhibitor; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HHF=hospitalisation for heart failure; LVEF=left ventricular ejection fraction; MRA=mineralocorticoid receptor antagonist; NT-proBNP=N terminal pro-brain natriuretic peptide; NYHA=New York Heart Association; T2D=type 2 diabetes.

In the treatment of HF patients with LVEF > 40%*

JARDIANCE is the 1st medicine clinically proven to reduce the risk of CV death or HHF‡1

CV DEATH OR HHF
CV DEATH OR HHF

†Proven=meeting the primary endpoint in clinical trials.

Consistent efficacy across LVEF subgroups and T2D or CKD status1

First and recurrent HHF

In the treatment of HF patients with LVEF > 40%*

JARDIANCE reduced the risk of first and recurrent HHF#1

RRR OF FIRST
RRR OF FIRST

In patients with HFpEF Jardiance® provides early onset of symptomatic relief (NYHA class improvement)21

week-12
week-12

  1. Anker SD, Butler J, Filippatos G, et al; EMPEROR-Preserved Trial Investigators. Empagliflozin in heart failure with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451-1461. doi:10.1056/NEJMoa2107038 (EMPEROR-Preserved results and the publication’s Supplementary Appendix.)

  2. Butler J, Siddiqi TJ, Filippatos G, et al. Early benefit with empagliflozin in heart failure with preserved ejection
    fraction: insights from the EMPEROR-Preserved trial. Eur J Heart Fail. Published online January 5, 2022.
    doi:10.1002/ejhf.2420

  • *
    Adult patients with chronic heart failure (NYHA class II, III, or IV) and preserved ejection fraction (LVEF > 40%).1
  • ‡
    In the EMPEROR-Preserved trial, a randomised , double blind, parallel-group, placebo-controlled study of 5988 patients with HFpEF, the efficacy and safety of JARDIANCE 10 mg (n=2997) were evaluated vs placebo (n=2991). The primary endpoint in the EMPEROR-Preserved trial was a composite of CV death or HHF, analysed as time to the first event. Patients treated with JARDIANCE experienced a 21% RRR in this endpoint (HR=0.79; 95% CI: 0.69, 0.90; p<0.001).1
  • §
    ARR calculation: JARDIANCE number of patients with events 415/total number of patients 2997=13.8%; placebo number of patients with events 511/total number of patients 2991=17.1%; 17.1% 13.8%=3.3%.1
  • ||
    ARR was estimated as the absolute difference in the proportion of events by treatment arm. NNT=1/ARR.1
  • Background treatment: All appropriate treatments for heart failure or comorbid conditions could be initiated or altered at the discretion of the clinician.1
  • #
    The occurrence of all HHF, including first and recurrent events, was a prespecified secondary outcome of the
    EMPEROR-Preserved trial.1
  • ARR=absolute risk reduction; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; HF=heart failure; 
    HFpEF =Heart failure with preserved ejection fraction; HHF=hospitalisation for heart failure; HR=hazard ratio; LVEF=left ventricular ejection fraction; NNT=number needed to treat; NYHA=New York Heart Association; RRR=relative risk reduction; T2D=type 2 diabetes.

PC-IN-103696 Validity till July 2025