MAKE PROTECTION
YOUR SUPERPOWER

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

MAKE PROTECTION 
YOUR SUPERPOWER

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

cardio-renal-metabolic-diseases
Early_intervention_is_the_best_way_to_protect_patients_from_these_risks

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 T2D+CVD§

38 % RRR IN CV DEATH

IN ADULT PATIENTS WITH T2D + CVD§

4.5 Years Life Extension vs. Placebo

IN ADULT PATIENTS WITH CHRONIC HEART FAILURE††

HF Benefits irrespective of T2D

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 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 insufficiently controlled T2D and CAD, PAD, or a history of MI or stroke.1,5
  • 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
  • ||
    Standard of care included CV medications and glucose-lowering agents given at the discretion of healthcare providers and according to recommendations of local guidelines.1,5
  • **
    According to nonparametric age-based Kaplan-Meier estimates of the survival curve, which were based on actuarial estimates of the age-specific probabilities of death for the pooled JARDIANCE® group and the placebo group in the EMPA-REG OUTCOME® trial. At 45 years of age, the estimated mean survival was 32.1 years in the JARDIANCE® group vs 27.6 years in the placebo group (difference, 4.5 years; 95% CI: 1.3, 7.8; p=0.007).13
  • ††
    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.4
  • ¶¶
    Results of prespecified subgroup analyses. EMPEROR-Reduced: Diabetes at baseline (HR=0.72; 95% CI: 0.60, 0.87); no diabetes at baseline (HR=0.78; 95% CI: 0.64, 0.97). eGFR (CKD-EPI) ≥ 60 mL/min/1.73 m2 at baseline (HR=0.67; 95% CI: 0.55, 0.83); eGFR (CKD-EPI) < 60 mL/min/1.73 m2 at baseline (HR=0.83; 95% CI: 0.69, 1.00).3 EMPEROR-Preserved: Diabetes at baseline (HR=0.79; 95% CI: 0.67, 0.94); no diabetes at baseline (HR=0.78; 95% CI: 0.64, 0.95). eGFR (CKD-EPI) ≥ 60 mL/min/1.73 m2 at baseline (HR=0.81; 95% CI: 0.65, 1.00); eGFR (CKD-EPI) < 60 mL/min/1.73 m2 at baseline (HR=0.78; 95% CI: 0.66, 0.91).4

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; 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. 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.

  13. Claggett B, Lachin JM, Hantel S, et al. Long-term benefit of empagliflozin on life expectancy in patients with type 2 diabetes mellitus and established cardiovascular disease: survival estimates from the EMPA-REG OUTCOME trial. Circulation. 2018;138(15):1599-1601.