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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

Patients with chronic HF need broad protection by reducing escalating risks6-8

Patients with chronic HF need broad protection by reducing escalating risks6-8
Early_intervention_is_the_best_way_to_protect_patients_from_these_risks

HELP PROTECT YOUR PATIENTS WITH HF - WITH JARDIANCE®

Early intervention is the best way to protect patients from these risks10-14

JARDIANCE® protects patients across the LVEF spectrum by reducing the risk of CV death or HHF1,3,4

JARDIANCE® protects patients across the LVEF

Build on the proven CV protection of JARDIANCE® 

With ~10,000 patients studied in randomized controlled trials 3,4,9, you can rely on the proven CV protection of JARDIANCE®

IN PATIENTS WITH LVEF ≤40%

IN PATIENTS WITH LVEF ≤40%#

JARDIANCE® reduced the risk of CV death or HHF in patients with HFrEF†3

Learn more about EMPEROR-Reduced
IN PATIENTS WITH LVEF >40%

IN PATIENTS WITH LVEF >40%#

JARDIANCE® reduced the risk of CV death or HHF in patients with HFpEF†4

Learn more about EMPEROR-Preserved
EMPULSE - Efficacy and safety profiles now confirmed in the hospital setting9

In the treatment of hospitalised patients ACROSS THE LVEF SPECTRUM AFTER STABILISATION#

EMPULSE - Efficacy and safety profiles now confirmed in the hospital setting9

Learn more about EMPULSE

IN THE TREATMENT OF PATIENTS WITH HF

JARDIANCE® significantly increased KCCQ score across the LVEF spectrum§§15,16

With JARDIANCE®, patients were more likely to experience early and sustained symptom relief§§## when added to background therapy vs placebo15,16

JARDIANCE® significantly increased KCCQ score across the LVEF spectrum

Related Content

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 insufficiently controlled T2D and CAD, PAD, or a history of MI or stroke.1,5
  • 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​
  • #
    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%. NNT=1/ARR.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).2 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).3,4
  • §§
    Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the KCCQ at Week 52 was a prespecified secondary endpoint in the EMPEROR-Reduced and EMPEROR-Preserved trials. KCCQ change from baseline to 52 weeks. EMPEROR-Reduced: JARDIANCE® 5.8 ± 0.4; placebo 4.1 ± 0.4. EMPEROR-Preserved: JARDIANCE® 4.51, placebo 3.18. Patient-reported outcomes measured changes in KCCQ summary scores. JARDIANCE® led to significant improvements in mean KCCQ-CSS, -TSS, and -OSS, which were apparent as early as 3 months and were sustained at 8 and 12 months. Patients treated with JARDIANCE® were more likely to show clinically meaningful improvements (≥ 5, ≥ 10, and ≥ 15 points) and less likely to experience clinically meaningful deterioration in health status when compared to placebo.3,4,16,17
  • ##
    Symptoms: shortness of breath, fatigue, or ankle, feet, and/or leg swelling.

ARR=absolute risk reduction; CAD=coronary artery disease; CI=confidence interval; CKD=chronic kidney disease; CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration; CSS=Clinical Summary Score; 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; KCCQ=Kansas City Cardiomyopathy Questionnaire; LVEF=left ventricular ejection fraction; MACE=major adverse cardiovascular events; MI=myocardial infarction; NNT=number needed to treat; NYHA=New York Heart Association; OSS=Overall Summary Score; PAD=peripheral artery disease; RRR=relative risk reduction; SE=standard error of the mean; TSS=Total Symptom Score; 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. Shah KS, Xu H, Matsouaka RA, et al. Heart failure with preserved, borderline, and reduced ejection fraction: 5-year outcomes. J Am Coll Cardiol. 2017;70(20):2476-2486. doi:10.1016/j.jacc.2017.08.074

  7. Sepehrvand N, Savu A, Spertus JA, et al; Alberta HEART Investigators. Change of health-related quality of life over time and its association with patient outcomes in patients with heart failure. J Am Heart Assoc. 2020;9(17):e017278. doi:10.1161/JAHA.120.017278

  8. House AA, Wanner C, Sarnak MJ, et al; Conference Participants. Heart failure in chronic kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2019;95(6):1304-1317. doi.org/10.1016/j.kint.2019.02.022

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Butler J, Anker SD, Filippatos G, et al; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021;42(13):1203-1212. doi:10.1093/eurheartj/ehaa1007

  16. Butler J, Filippatos G, Siddiqi J, et al. Empagliflozin, health status, and quality of life in patients with heart failure and preserved ejection fraction: the EMPEROR-Preserved trial. Circulation. 2022;145(3):184-193. doi:10.1161/CIRCULATIONAHA.121.057812