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MAKE PROTECTION
YOUR SUPERPOWER

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

Learn More
MAKE PROTECTION 
YOUR SUPERPOWER

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

Cardio, renal, and metabolic diseases are 
interconnected!8

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

JARDIANCE® offers a range of benefits for your 
patients with T2D+CVD1

metabolic
cardio
renal

IN ADULT PATIENTS WITH T2D+CVD

HbA1c, Systolic BP, and Weight benefits¶1,13,14

HbA1c, Systolic BP, and Weight benefits

In insulin-naïve patients with T2D+CVD§

60% RRR in the need for Insulin initiation##16

60% RRR in the need for Insulin initiation

In insulin-treated patients with T2D+CVD§

58% RRR in large Insulin doses¶¶16

58% RRR in large Insulin doses

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
  • In a 24-week, double-blind, placebo-controlled study of 637 patients with T2D, the efficacy and safety profiles of JARDIANCE® 10 mg (n=217) and JARDIANCE® 25 mg (n=213) as add-on therapy to metformin ≥ 1500 mg were evaluated vs placebo added to metformin (n=207). The primary endpoint was adjusted mean change (SE) from baseline in HbA1c (%); weight loss and blood pressure reduction were key secondary and exploratory endpoints, respectively.13 JARDIANCE® is not indicated for weight loss or reduction of blood pressure.1
  • #
    Adjusted mean changes of –0.1% from baseline HbA1c 7.9% for placebo (n=207), –0.7% from baseline HbA1c 7.9% for JARDIANCE® 10 mg (n=217), and –0.8% from baseline HbA1c 7.9% for JARDIANCE® 25 mg (n=213), respectively. Difference from placebo (adjusted mean) was –0.6% for both JARDIANCE® 10 mg and 25 mg; p<0.001 vs placebo for both doses.1,13
  • ||
    In a subgroup analysis at 24 weeks of patients with baseline ≥ 8.5%, adjusted mean changes in HbA1c were –0.5% for placebo (n=50), –1.2% for JARDIANCE® 10 mg (n=57), and –1.5% for JARDIANCE® 25 mg (n=48). Difference from placebo (adjusted mean) was –0.73% for JARDIANCE® 10 mg and –1.0% for JARDIANCE® 25 mg. Missing data were imputed using the last observation carried forward (LOCF) approach.14
  • **
    Adjusted mean change in systolic blood pressure from baseline at 24 weeks: JARDIANCE® 10 mg –4.5 mmHg (n=217), JARDIANCE® 25 mg –5.2 mmHg (n=213), vs placebo –0.4 mmHg (n=207).13
  • ††
    Adjusted mean changes of –0.45 kg reduction in body weight from baseline 79.7 kg for placebo (n=207), –2.08 kg from baseline 81.6 kg for JARDIANCE® 10 mg (n=217), and –2.46 kg from baseline 82.2 kg for JARDIANCE® 25 mg (n=213), respectively; p<0.0001 vs placebo for both doses.1,13
  • §§
    In a subgroup analysis at 24 weeks of patients with baseline BMI ≥ 35, adjusted mean changes in weight were –0.34 kg for placebo (n=29), –2.63 kg for JARDIANCE® 10 mg (n=33), and –3.35 kg for JARDIANCE® 25 mg (n=41). Difference from placebo (adjusted mean) was –2.28 for JARDIANCE® 10 mg and –3.01 for JARDIANCE® 25 mg.14
  • ¶¶
    In a double-blind extension trial, adjusted mean changes in weight for patients with baseline BMI ≥ 35 at Week 76 were 0.23 kg for placebo (n=29), –3.74 kg for JARDIANCE® 10 mg (n=33), and –4.77 kg for JARDIANCE® 25 mg (n=41). Difference from placebo (adjusted mean) was –3.96 kg for JARDIANCE® 10 mg and –4.99 kg for JARDIANCE® 25 mg. Missing data were imputed using the LOCF approach.14
  • ##
    Outcome of insulin initiation was defined to be maintained on ≥ 2 consecutive visits ≥ 13 weeks apart. Cox regression model adjusted for baseline HbA1c, time since T2D diagnosis, BMI, eGFR, geographic region, and treatment status. Kaplan-Meier estimates.16
  • ¶¶
    Sustained insulin dose increase was defined as time to first increase in total daily insulin dose by > 20% from baseline total daily insulin dose, sustained for at least 2 consecutive visits at a minimum of 13 weeks apart, analyzed in patients treated with insulin at baseline.16

ARR=absolute risk reduction; BMI=body mass index; BP=blood pressure; 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; SBP=systolic blood pressure; SE=standard error of the mean; 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. Häring HU, Marker L, Seewaldt-Becker E, et al; EMPA-REG MET Trial Investigators. Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2014;37(6):1650-1659.

  14. Inzucchi SE, Davies MJ, Khunti K, et al. Empagliflozin treatment effects across categories of baseline HbA1c, body weight, and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021;23(2):425-433

  15. Ridderstrale M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU Trial Investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014;2(9):691-700.

  16. Vaduganathan M, Inzucchi SE, Sattar N, et al. Effects of empagliflozin on insulin initiation or intensification in patients with type 2 diabetes and cardiovascular disease: findings from the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2021;23(12):2775-2784.