Header
For Healthcare Professionals
Carosel_01_new11
Footnotes
  • *
    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).2
  • †
    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).3
  • ‡
    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).4
  • §
    JARDIANCE is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients of JARDIANCE. JARDIANCE should not be used in patients with type 1 diabetes or for the treatment of DKA. JARDIANCE should be used with caution in patients who may be at a higher risk of ketoacidosis while taking JARDIANCE. In patients where DKA is suspected or diagnosed, treatment with JARDIANCE should be discontinued immediately. For use in patients with renal impairment, please refer to the dosing page of this document and the SmPC.1
  • ll
    Please see the Indian Prescribing Information for dosing details.
  • CAD=coronary artery disease; CI=confidence interval; CV=cardiovascular; DKA=diabetic ketoacidosis; eCVD=established cardiovascular disease; HF=heart failure; HHF=hospitalisation for 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 event; MI=myocardial infarction; NYHA=New York Heart Association; PAD=peripheral artery disease; RRR=relative risk reduction; SmPC=summary of prescribing characteristics; T2D=type 2 diabetes.
References

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

  2. 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.)

  3. 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.)

  4. 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.)