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FOR YOUR PATIENTS WITH CKD#

JARDIANCE® reduces kidney disease progression or risk of CV death*1,2

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FOR YOUR PATIENTS WITH T2D+CVD††

JARDIANCE® reduces risk of CV death‡§§5

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FOR YOUR PATIENTS WITH HF‡‡##

JARDIANCE® reduces risk of CV death or HHF†3,4

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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
  • §
    ARR for the primary composite outcome of kidney disease progression or CV death is 3.6% per patient-year at risk. Figure adapted from Herrington et al.2
  • NNT: 28 (95% CI: 19, 53) per 2 years at risk.2
  • #
    Adult patients with an eGFR ≥ 20, < 45 mL/min/1.73 m2; or an eGFR ≥ 45, < 90 mL/min/1.73 m2 with a uACR ≥ 200 mg/g.2​
  • ||
    CV death was part of the composite primary endpoint, 3-point MACE, in the EMPA-REG OUTCOME® trial (HR=0.86; 95% CI: 0.74, 0.99; p<0.001 for noninferiority; p=0.04 for superiority) and 38% RRR in CV death was achieved in the overall EMPA-REG OUTCOME® population for the duration of the trial (HR=0.62; 95% CI: 0.49, 0.77; p<0.001).1,5
  • **
    Pooled data from 10-mg and 25-mg doses of JARDIANCE®; both doses showed a comparable reduction in the risk of CV death.1,5
  • ††
    Adult patients with insufficiently controlled T2D and CAD, PAD, or a history of MI or stroke.1,5
  • §§
    In addition to reducing the risk of CV death when added to the standard of care, JARDIANCE® also lowered HbA1c. In addition, JARDIANCE® demonstrated reduction in weight and blood pressure. JARDIANCE® is not indicated for weight loss or reduction of blood pressure.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
  • ***
    ARR calculation: JARDIANCE® number of patients with events 361/total number of patients 1863=19.4%; placebo number of patients with events 462/total number of patients 1867=24.7%; 24.7%–19.4%=5.3%.3
  • †††
    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%.4
  • ‡‡‡
    ARR was estimated as the absolute difference in the proportion of events by treatment arm. NNT=1/ARR.
  • ARR=absolute risk reduction; CAD=coronary artery disease; CI=confidence interval; CKD=chronic kidney disease; 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; 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® [Local summary of product characteristics]. Ingelheim am Rhein, Germany.

  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. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024;105(4S):S117-S314. doi:10.1016/j.kint.2023.10.018

Document ID: PC-SA-102620 | Expiry Date: 01/30/2027