jardiance
MAKE PROTECTION

CKD-Expanded

DID YOU KNOW THAT CKD ACTS AS A RISK MULTIPLIER?6,7

Cardio, renal, and metabolic diseases are interconnected!8

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help-protect

HELP PROTECT YOUR PATIENTS WITH JARDIANCE®

Early intervention is the best way to help protect patients from these interrelated conditions6,9-12
IN ADULT PATIENTS WITH CHRONIC KIDNEY DISEASE§

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

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IN ADULT PATIENTS WITH CHRONIC KIDNEY DISEASE§

JARDIANCE® helped protect patients by giving more time out of hospital*††2

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deepdrive
Deep Dive into EMPA-KIDNEY2 

Secondary Endpoints, Statistical Analyses and more insights.

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summary
Summary Video EMPA-KIDNEY2

Prof. Will Herrington explains the key outcomes of the broadest SGLT2i CKD trial to date.

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IN ADULT PATIENTS WITH CHRONIC KIDNEY DISEASE§

JARDIANCE® demonstrated consistent kidney and CV efficacy outcomes across the broadest spectrum of subgroups*2

JARDIANCE® is appropriate for a broad CKD patient population§ you see every day in your practice

jardiance-demonstrated-consistent-kidney-and-cv-efficacy-outcomes-across-the-broadest-spectrum-of-subgroups
jardiance-demonstrated-consistent-kidney-and-cv-efficacy-outcomes-across-the-broadest-spectrum-of-subgroups
IN THE TREATMENT OF PATIENTS WITH CKD WITH OR WITHOUT T2D

JARDIANCE® protected the kidney by slowing the decline of renal function over time*§§2

By slowing the decline, JARDIANCE® may prolong better kidney function vs standard of care##

jardiance-protected-the-kidney-by-slowing-the-decline-of-renal-function-over-time
jardiance-protected-the-kidney-by-slowing-the-decline-of-renal-function-over-time
IN THE TREATMENT OF PATIENTS WITH CKD WITH OR WITHOUT T2D

New evidence across the spectrum of uACR in a previously understudied*** patient population*2

In the primary endpoint, the benefit of JARDIANCE® was greater in patients with severely increased baseline albuminuria

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new-evidence-across-the-spectrum-of-uacr
IN THE TREATMENT OF PATIENTS WITH CKD WITH OR WITHOUT T2D

JARDIANCE® helped protect††† the kidneys across the spectrum of uACR by slowing eGFR decline

JARDIANCE® can protect††† kidney function by slowing eGFR decline even in patients with reduced eGFR§ who do not show kidney damage (indicated by uACR)

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jardiance-helped-protect-the-kidneys-across

Related Content

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 of JARDIANCE® 10 mg (n=1863) were 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 of JARDIANCE 10 mg (n=2997) were 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).4,5
  • †
    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 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
  • ||
    Standard of care: All patients received a RAASi unless an investigator judged that a RAASi was not indicated or tolerated.2​
  • #
    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
  • **
    History of diabetes was defined as a patient-reported history of diabetes of any type, use of glucose-lowering medication, or a glycated hemoglobin level of at least 48 mmol per mole (6.5%) at the randomization visit. More than 95% of patients with diabetes had type 2.2
  • ††
    Hospitalization for any cause was a key secondary outcome of the EMPA-KIDNEY trial. The analysis of hospitalizations for any cause included the first and all subsequent events (JARDIANCE®, 1611 hospitalizations in 960 patients; placebo, 1895 hospitalizations in 1035 patients).2
  • ‡‡
    Values represent the measurement recorded at the randomization visit or the most recent local laboratory result recorded before randomisation.2
  • §§
    Progression of kidney disease was a prespecified secondary outcome of the EMPA-KIDNEY trial.2
  • ##
    JARDIANCE® gives you the opportunity to delay the initiation of dialysis for patients with CKD2
  • ¶¶
    Values represent the mean (± SE) changes from 2 months after the first dose of JARDIANCE® or placebo to the final follow-up visit.2
  • ***
    Patients enrolled in the EMPA-KIDNEY trial included groups excluded from or under-represented in the other SGLT2i trials with a primary focus on kidney disease progression.2
  • †††
    Annual rate of change in eGFR was a prespecified exploratory outcome in the EMPA-KIDNEY trial. Shown are the results of long-term slope, representing the mean (±SE) changes from 2 months after the first dose of JARDIANCE® or placebo to the final follow-up visit.1,2
  • 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; RAASi=renin-angiotensin-aldosterone system inhibitor; RRR=relative risk reduction; T2D=type 2 diabetes; uACR=urinary albumin-to-creatinine ratio.
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. GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020;395(10225):709-733.

  7. Jankowski J, Floege J, Fliser D, Böhm N, Marx N. Cardiovascular disease in chronic kidney disease: pathophysiological insights and therapeutic options. Circulation. 2021;143(11):1157-1172.

  8. Kalra S, Aydin H, Sahay M, et al. Cardiorenal syndrome in type 2 diabetes mellitus—rational use of sodium-glucose cotransporter-2 inhibitors. Eur Endocrinol. 2020;16(2):113-121.

  9. McDonagh TA, Metra M, Adamo M, et al. ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-3726.

  10. Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycemia in type 2 diabetes, 2022: a consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753-2786.

  11.  Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Acad Cardiol. 2022;79(17):e263-e421.

  12. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2013;3(1):1-150.

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