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NOW APPROVED FOR CKD!

MAKE PROTECTION
YOUR SUPERPOWER

JARDIANCE® protects by reducing risk for 
adult patients with CKD*1,2, HF†3,4 and T2D+CVD.‡5

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MAKE PROTECTION 
YOUR SUPERPOWER

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

EMPULSE - JARDIANCE® has demonstrated its efficacy and safety profile across the LVEF spectrum when initiated in hospital
EMPULSE Flowchart

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

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 efficacy
prof piotr

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 with 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. 28, 778–796 (2018).