jardiance
MAKE PROTECTION
Learn More:Dosing recommendations
Learn More:Safety profile

JARDIANCE® is easy to use across a 
broad spectrum of patients†1

JARDIANCE® is easy to use across a broad spectrum of patients†1
JARDIANCE® is easy to use across a broad spectrum of patients†1
  • *
    - In CKD and HF, Jardiance can be initiated down to an eGFR of 20ml/min/1.73 m2
  • - For people with T2D and CV disease, Jardiance can be initiated down to 30 ml/min/1.73 m2
In patients with T2D
  • In patients with T2D who tolerate 10 mg once daily who have an eGFR ≥ 60 mL/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily†1
  • In patients with type 2 diabetes mellitus, the glucose lowering efficacy of empagliflozin is reduced in patients with an eGFR <45 ml/min/1.73 m2 and likely absent in patients with an eGFR <30 ml/min/1.73 m2. Therefore, if eGFR falls below 45 ml/min/1.73 m2, additional glucose lowering treatment should be considered if needed†1

See SmPC

Footnotes

* Please see the Summary of Product Characteristics for complete safety information.1

† Please see the Summary of Product Characteristics for dosing details.1

eGFR=estimated glomerular filtration rate; T2D=type 2 diabetes.

Reference

1. JARDIANCE® [Local summary of product characteristics]. Ingelheim am Rhein, Germany.

Related Content

Indication

Type 2 diabetes mellitus: 

  • 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

Heart failure

  • Jardiance is indicated in adult patients with heart failure (NYHA class II-IV) independent of left ventricular ejection fraction, with or without type 2 diabetes mellitus: 

  • To reduce the risk of cardiovascular death and hospitalization for heart failure

  • To slow kidney function decline

Chronic kidney disease

  • 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 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 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 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

CAD=coronary artery disease; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; 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; NYHA=New York Heart Association; PAD=peripheral artery disease; RRR=relative risk reduction; T2D=type 2 diabetes.  

References
  • 1.
    JARDIANCE® [Local summary of product characteristics]. Ingelheim am Rhein, Germany.
  • 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.)

Document ID: PC-SA-102620 | Expiry Date: 01/30/2027