JARDIANCE® protects by reducing risk for adult patients with1

Type-2 diabetes significantly increases risk of untimely cardiovascular death

People with diabetes have 3 to 4 times higher risk of cardiovascular death.1,6

JARDIANCE® offers your patients triple protection for CV, renal, and metabolic conditions2-5

JARDIANCE® offers your patients triple protection: for CV, renal, and metabolic conditions2-5

38%

RRR in CV death; NNT=46

(T2D + eCVD)*2

28%

RRR in CV death or kidney disease

progression;
NNT=28 (CKD)†3

25%

RRR in CV death or hospitalisation for HF; NNT=19 (HFrEF)‡4

21%

RRR in CV death or hospitalisation for HF; NNT=31 (HFpEF)§5

38%

RRR in CV death and 35% RRR in HHF vs Placebo2

JARDIANCE® should be used first line in appropriate patients with T2D, CKD, or HF7-11

JARDIANCE® is the only SGLT2i proven to reduce the risk of CV death in patients with T2D + eCVD¶2,12

For your patients with T2D and eCVD||

JARDIANCE® is the only SGLT2i proven to reduce the risk of CV death in patients with T2D + eCVD*¶2,12
38% RCC in CV death
38% RCC in CV death
  • JARDIANCE® reduced the risk of CV death independent of multiple baseline characteristics‡‡§§2,19
  • JARDIANCE® demonstrated results that can help extend life vs placebo||||20
  • JARDIANCE® reduced the need for insulin21

Results from the EMPA-REG OUTCOME® trial.

Jardiance T2D heart icon

For your patients with T2D and CV disease*

Reduction in risk of CV death was independent of¶2,19:
jardiance T2D check mark icon

Baseline HbA1c

jardiance T2D check mark icon
Baseline BMI
jardiance T2D check mark icon
Baseline BP
jardiance T2D check mark icon
Baseline eGFR§§
jardiance T2D check mark icon
Change in HbA1c
Upto 4.5 years of life extended with JARDIANCE® vs. placebo

Upto 4.5 years of life extended with JARDIANCE® vs. placebo

 

Based on a 45-year-old patient with T2D and eCVD**14

  1. API dated 19th Jul 2024 (Based on JARDIANCE® approved prescribing information dated 18th Jul 2024).

  2. 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.)

  3. 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.)

  4. 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.)

  5. 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.)

  6. 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.

  7. 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.

  8. 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 Coll Cardiol. 2022;79(17):e263-e421.

  9. 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.

  10. Paul SK, Klein K, Thorsted BL, Wolden ML, Khunti K. Delay in treatment intensification increases the risks of cardiovascular events in patients with type 2 diabetes. Cardiovasc Diabetol. 2015;14:100.

  11. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024;105(suppl 4S):S117-S314.

  12. Ramlo-Halsted BA, Edelman SV. The natural history of type 2 diabetes: implications for clinical practice. Prim Care. 1999;26(4):771-789.

  13. UK Prospective Diabetes Study Group. UK prospective diabetes study 16. Overview of 6 years' therapy of type 2 diabetes: a progressive disease. Diabetes. 1995;44(11):1249-1258.

  14. Laakso M. Cardiovascular disease in type 2 diabetes from population to man to mechanisms. Diabetes Care. 2010;33(2):442-449.

  15. Ma C-X, Ma X-N, Guan C-H, Li Y-D, Mauricio D, Fu S-B. Cardiovascular disease in type 2 diabetes mellitus: progress toward personalized management. Cardiovasc Diabetol. 2022;21(74):1-15.

  16. American Diabetes Association. Cardiovascular disease. Accessed September 25, 2024. https://diabetes.org/about-diabetes/complications/cardiovascular-disease

  17. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

  18. 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.

  19. Inzucchi SE, Kosiborod M, Fitchett D, et al. Improvement in cardiovascular outcomes with empagliflozin is independent of glycemic control. Circulation. 2018;138(17):1904-1907.

  20. 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.

  21. 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.

  22. Verma S, Leiter LA, Sharma A, et al. How early after treatment initiation are the CV benefits of empagliflozin apparent? A post hoc analysis of EMPA-REG OUTCOME. Diabetes. 2020;69(suppl 1):28-OR.

  • *
    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); there was no change in risk of nonfatal MI (HR=0.87; 95% CI: 0.70, 1.09) or nonfatal stroke (HR=1.24; 95% CI: 0.92, 1.67).2,22
  • 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. Patients treated with JARDIANCE® experienced a 28% RRR in this endpoint (HR=0.72; 95% CI: 0.64, 0.82; p<0.001).3
  • 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 HF (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 hospitalisation for HF, 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).4
  • §
    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 HF (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 hospitalisation for HF, 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).5
  • ||
    In the EMPULSE trial, a randomised, double-blind, placebo-controlled study of 530 patients with chronic heart failure regardless of LVEF, the efficacy and safety of JARDIANCE® 10 mg (n=265) were evaluated vs placebo (n=265). The primary endpoint in the EMPULSE trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5-point or greater difference in change from baseline in the KCCQ-TSS at 90 days, as assessed using a win ratio. Patients treated with JARDIANCE® experienced an overall clinical benefit 36% more likely than with placebo (win ratio 1.36; 95% CI: 1.09, 1.68; p=0.0054).2
  • Adult patients with insufficiently controlled T2D and CAD, PAD, or a history of MI or stroke.2
  • #
    In addition to reducing the risk of CV death when added to the standard of care, JARDIANCE® also lowered HbA1c. In addition, JARDIANCE® demonstrated reduction in weight and blood pressure. JARDIANCE® is not indicated for weight loss or reduction of blood pressure.2
  • **
    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). There were no significant differences between the placebo and JARDIANCE® groups of nonfatal MI (HR=0.87; 95% CI: 0.70, 1.09; p=0.22) or nonfatal stroke (HR=1.24; 95% CI: 0.92, 1.67; p=0.16).2
  • ††
      Pooled data from 10-mg and 25-mg doses of JARDIANCE®; both doses showed a comparable reduction in the risk of CV death.2
  • ‡‡
      Standard of care included CV medications and glucose-lowering agents given at the discretion of healthcare providers and according to recommendations of local guidelines.2
  • §§
      A post hoc analysis of data from the EMPA-REG OUTCOME® trial by baseline HbA1c subgroups. EMPA-REG OUTCOME® was not powered to show differences between subgroups.2,19
  • ||||
      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).20
  • ACEi,
           angiotensin-converting enzyme inhibitor; 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; DBP, diastolic blood pressure; eCVD, established cardiovascular disease; eGFR, estimated glomerular filtration rate; HbA1c, glycated hemoglobin; HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; HR, hazard ratio; HHF, hospitalization for heart failure; KCCQ-TSS, Kansas City Cardiomyopathy Questionnaire total symptom score; 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; PCP, primary care physician; RRR, relative risk reduction; SBP, systolic blood pressure; SGLT2i, sodium-glucose cotransporter-2 inhibitor; T2D, type 2 diabetes.

PC-IN-103695