jardiance
MAKE PROTECTION
IN THE TREATMENT OF HOSPITALISED PATIENTS WITH HFrEF AND HFpEF AFTER STABILISATION§

EMPULSE -
JARDIANCE® has demonstrated its efficacy and safety profile across the LVEF spectrum when initiated in hospital1,3,4,6

overall-36
overall-36
placebo-img
placebo-img

In the EMPULSE trial, primary analysis was determined by a hierarchical composite endpoint of all-cause death, number of HF events, time to 1st HF event, and change from baseline KCCQ-TSS (≥5 points) at 90 days, using a win ratio.#6

The win ratio is a validated approach, in which each patient from the treatment arm is compared with every patient from the control arm.7

proven-safety
proven-safety
IN THE TREATMENT OF HOSPITALISED PATIENTS WITH HFrEF AND HFpEF AFTER STABILISATION§

JARDIANCE® demonstrated a proven clinical benefit consistent across subgroups when initiated in hospital6

primary
primary
Prof Piotr Ponikowski

PROF. PIOTR PONIKOWSKI EXPLAINS

EMPULSE6

Everything you need to know about EMPULSE6 - study design, key outcomes, efficacy & safety aspects.

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Indication & Footnotes

JARDIANCE® is indicated for the treatment of adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance

  • in addition to other medicinal products for the treatment of diabetes

JARDIANCE® is indicated in adults for the treatment of symptomatic chronic heart failure. 

JARDIANCE® is indicated in adults for the treatment of chronic kidney disease.

  • *
    In the EMPA-KIDNEY trial, a randomised, parallel-group, double-blind, placebo-controlled study of 6609 patients with CKD, the efficacy and safety profile of JARDIANCE® 10 mg (n=3304) was evaluated vs placebo (n=3305). The primary endpoint in the EMPA-KIDNEY trial was a composite of CV death or progression of kidney disease defined as end-stage kidney disease (the initiation of maintenance dialysis or receipt of a kidney transplant), a sustained decrease in the eGFR to <10 ml/min/1.73 m2, a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes. Patients treated with JARDIANCE® experienced a 28% RRR in this endpoint (HR=0.72; 95% CI: 0.64, 0.82; p<0.001).2
  • †
    In the EMPEROR-Reduced trial, a randomised, double-blind, parallel-group, placebo-controlled study of 3730 patients with HFrEF, the efficacy and safety profile of JARDIANCE® 10 mg (n=1863) was evaluated vs placebo (n=1867). Patients were adults with chronic heart failure (NYHA class II, III, or IV) and reduced ejection fraction (LVEF ≤ 40%). The primary endpoint in the EMPEROR-Reduced trial was a composite of CV death or HHF, analysed as time to the first event. Patients treated with JARDIANCE® experienced a 25% RRR in this endpoint (HR=0.75; 95% CI: 0.65, 0.86; p<0.001). In the EMPEROR-Preserved trial, a randomised, double-blind, parallel-group, placebo-controlled study of 5988 patients with HFpEF, the efficacy and safety profile of JARDIANCE® 10 mg (n=2997) was evaluated vs placebo (n=2991). Patients were adults with chronic heart failure (NYHA class II, III, or IV) and preserved ejection fraction (LVEF > 40%). 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).3,4
  • ‡
    The primary composite outcome in the EMPA-REG OUTCOME® trial was 3-point MACE, composed of death from CV causes, nonfatal MI, or nonfatal stroke, as analyzed in the pooled JARDIANCE® group vs the placebo group. Patients were adults with insufficiently controlled T2D and CAD, PAD, or a history of MI or stroke. The 14% RRR in 3-point MACE (HR=0.86; 95% CI: 0.74, 0.99; p<0.001 for noninferiority; p=0.04 for superiority) was driven by a reduction in the risk of CV death (HR=0.62; 95% CI: 0.49, 0.77).5
  • §
    Adult patients with chronic heart failure (NYHA class II, III, or IV) and reduced ejection fraction (LVEF ≤ 40%).3 Adult patients with chronic heart failure (NYHA class II, III, or IV) and preserved ejection fraction (LVEF > 40%).4
  • #
    In the EMPULSE trial, a randomized, double-blind, placebo-controlled study of 530 patients with chronic heart failure regardless of LVEF, the efficacy and safety of JARDIANCE® 10 mg (n=265) were evaluated in the hospital setting vs placebo (n=265). The primary endpoint in the EMPULSE trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5-point or greater difference in change from baseline in the KCCQ-TSS at 90 days, as assessed using a win ratio. Patients treated with JARDIANCE® experienced an overall clinical benefit 36% more likely than with placebo (win ratio=1.36; 95% CI: 1.09, 1.68; p=0.0054).6
  • ARR=absolute risk reduction; CAD=coronary artery disease; CI=confidence interval; CKD=chronic kidney disease; CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; HF=heart failure; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; HR=hazard ratio; LVEF=left ventricular ejection fraction; KCCQ-TSS=Kansas City Cardiomyopathy Questionnaire Total Symptom Score; MACE=major adverse cardiovascular events; MI=myocardial infarction; NNT=number needed to treat; NYHA=New York Heart Association; PAD=peripheral artery disease; RRR=relative risk reduction; T2D=type 2 diabetes.
References
  • 1.
    JARDIANCE® [summary of product characteristics]. Ingelheim am Rhein, Germany; Boehringer Ingelheim International GmbH.
  • 2.
    Herrington WG, Staplin N, Wanner C, et al. EMPA-KIDNEY Collaborative Group. Empagliflozin in patients with chronic kidney disease. N Engl J Med. 2023;388(2):117-127. (EMPA-KIDNEY results and the publication’s Supplementary Appendix.)
  • 3.
    Packer M, Anker SD, Butler J, et al. EMPEROR-Reduced Trial Investigators Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383(15):1413-1424. (EMPEROR-Reduced results and the publication’s Supplementary Appendix.)
  • 4.
    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. (EMPEROR-Preserved results and the publication’s Supplementary Appendix.)
  • 5.
    Zinman B, Wanner C, Lachin JM, et al. EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117-2128. (EMPA-REG OUTCOME® results and the publication’s Supplementary Appendix.) 
  • 6.
    Voors AA, Angermann CE, Teerlink JR, et al. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022;28(3):568-574. doi:10.1038/s41591-021-01659-1
  • 7.
    Dong G, Qiu J, Wang D. & Vandemeulebroecke M. The stratified win ratio. J Biopharm Stat. 2018;28:778-796.

Document ID: PC-SA-102639 | Expiry Date: 09/02/2026