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

MAKE PROTECTION 
YOUR SUPERPOWER

The interconnectivity of cardio, renal, and metabolic diseases amplifies and accelerates risk16, as evidenced by the latest treatment guidelines that emphasize the importance of reducing the risk of CV events and/or disease progression in patients with T2D, HF, and/or CKD.6-15

Global guidelines recommend SGLT2i to reduce 
CV risk for patients with T2D, HF, and/or CKD6-15

ADA, EASD, ESC and other guidelines endorse the early and foundational use of an SGLT2i to reduce cardio-renal risk for patients with T2D and elevated CV risk.6,7,9 SGLT2i are also recommended in patients with T2D and CKD to reduce the risk of HF.11

guideline risk reduction

Related Content

Indication

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.

Footnotes
  • *
    In the EMPA-KIDNEY trial, a randomised, parallel-group, double-blind, placebo-controlled study of 6609 patients with CKD, the efficacy and safety of JARDIANCE® 10 mg (n=3304) were 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).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 analysed 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
  • §
    For patients with T2D who have established/ high risk of ASCVD, HF, and/or, CKD, the 2023 ADA Standards of Care in Diabetes and the 2022 ADA/EASD Consensus Report recommend a treatment regimen that include agents reducing cardio-renal risk and recommend an SGLT2 inhibitor and/or GLP-1 receptor agonist with demonstrated CVD benefit as part of the glucose-lowering regimen and comprehensive cardiovascular risk reduction, independent of A1C and in consideration of person-specific factors.6,7
  • For patients with T2D and CVD, or at very high/high risk, the 2019 ESC/EASD guidelines on diabetes, pre-diabetes, and cardiovascular diseases recommend an SGLT2 inhibitor to reduce CV events and to reduce the risk of death.9
  • #
    For patients with T2D and established HFrEF or HFpEF, the 2023 ADA Standards of Care in Diabetes recommend an SGLT2i with proven benefit in such population to reduce the risk of worsening HF and CV death.6
  • ||
    For patients with diabetes, the 2019 ESC/EASD guidelines on diabetes, pre-diabetes, and cardiovascular diseases recommend treatment with an SGLT2i that is associated with a lower risk of renal endpoints if eGFR is 30 to <90 mL/min/ 1.73 m2 to prevent and manage CKD.9
  • **
    The 2021 ESC guidelines and the 2023 Focused Update for the diagnosis and treatment of acute and chronic heart failure recommends (class I, level A) an SGLT2 inhibitor in patients with HFrEF, HFmREF, and HFpEF to reduce the risk of HHF or CV death.10,11 
  • ††
    The 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure recommends an SGLT2i to reduce HHF and CV death in patients with HFrEF, regardless of T2D status (1A), and in patients with HFmrEF and HFpEF (2a, B-R).12 
  • ‡‡
    The 2021 CCS/CHFS Heart Failure Guidelines Update recommends an SGLT2i to improve symptoms and quality of life and to reduce the risk of HHF and/or CV mortality in patients with HFrEF with or without concomitant T2D.13
  • §§
    For patients with HFrEF, the CCS/CHFS Heart Failure Guidelines Update recommends an SGLT2i to improve symptoms and QoL and to reduce the risk of HHF and/or CV death.13 
  • ##
    For patients with T2D and CKD, the 2022 KDIGO Diabetes Management in CKD Guideline recommends a comprehensive strategy to reduce the risk of kidney disease progression and CV disease, which includes metformin, SGLT2 inhibitors, RAS blockade and statins as first-line therapies in addition to a foundation of lifestyle modification and self-management for all patients.14 
  • ¶¶
    According to both the 2022 ADA/KDIGO Consensus Report and 2022 KDIGO Diabetes Management in CKD Guideline, SGLT2i should be initiated when eGFR is ≥ 20 mL/min/1.73 m2 and continued, as tolerated, until dialysis or kidney replacement therapy is initiated.8,14

ACC=American College of Cardiology; ADA=American Diabetes Association; AHA=American Heart Association; ARR=absolute risk reduction; ASCVD=atherosclerotic cardiovascular disease; CAD=coronary artery disease; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; EASD=European Association for the Study of Diabetes; eGFR=estimated glomerular filtration rate; ESC=European Society of Cardiology; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HF=heart failure; HFSA=Heart Failure Society of America; HHF=hospitalisation for heart failure; HFpEF=heart failure with preserved ejection fraction; HFmrEF=heart failure with mildly reduced ejection fraction; HFrEF=heart failure with reduced ejection fraction; HR=hazard ratio; KDIGO=Kidney Disease: Improving Global Outcomes; LVEF=left ventricular ejection fraction; MACE=major adverse cardiovascular events; MI=myocardial infarction; NYHA=New York Heart Association; PAD=peripheral artery disease; QoL=quality of life; RAS=renin-angiotensin system; RRR=relative risk reduction; SGLT2=sodium-glucose cotransporter 2; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes; uACR=urinary albumin-to-creatinine ratio.

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. Standards of care in diabetes—2023. Khan SE, ed. Diabetes Care. 2023;46(suppl 1):S1-S291.

  7. 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.

  8. de Boer IH, Khunti K, Sadusky T, et al. Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO). Diabetes Care. 2022;45(12):3075-3090.

  9. Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD [published correction appears in Eur Heart J. 2020 Dec 1;41(45):4317]. Eur Heart J. 2020;41(2):255-323. doi:10.1093/eurheartj/ehz486 

  10. McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-3726. https://doi.org/10.1093/eurheartj/ehab368 

  11. McDonagh TA, Metra M, Adamo M, et al. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure [published online ahead of print, 2023 Aug 25]. Eur Heart J. 2023;ehad195. doi:10.1093/eurheartj/ehad195.

  12. 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 

  13. McDonald M, Virani S, Chan M, et al. CCS/CHFS heart failure guidelines update: defining a new pharmacologic standard of care for heart failure with reduced ejection fraction. Can J Cardiol. 2021;37(4):531-546. doi:10.1016/j.cjca.2021.01.017 

  14. Rossing P, Caramori ML, Chan JCN, et al. Executive summary of the KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease: an update based on rapidly emerging new evidence. Kidney Int. 2022;102(5):990-999.

  15. Levin A, Stevens P, et al. KDIGO 2023 Clinical Practice Guideline for the evaluation and management of chronic kidney disease. Public Review Draft. July 2023. Accessed January 17, 2024. https://kdigo.org/wp-content/uploads/2017/02/KDIGO-2023-CKD-Guideline-Public-Review-Draft_5-July-2023.pdf. 

  16. 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. 

  17. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc