*Adult patients with insufficiently controlled T2D and CAD, PAD, or a history of MI or stroke.^2,3

^†Post hoc analysis of the EMPA-REG OUTCOME® trial for successive HRs (95% CI) for Empagliflozin (JARDIANCE®) vs placebo for HHF, CV death/HHF, and CV death for the first day the benefits reach statistical significance. Cox regression for time to the endpoint, pooled Empagliflozin (JARDIANCE®) vs placebo.¹

^‡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 Empagliflozin (JARDIANCE®) group and the placebo group in the EMPA-REG OUTCOME® trial. At 60 years of age, the estimated mean survival was 21.8 years in the Empagliflozin (JARDIANCE®) group vs 19.2 years in the placebo group (difference, 2.5 years; 95% CI: 1.1, 3.9; p=0.001).⁵

^§CV death was part of the composite primary endpoint, 3-point MACE in the EMPA-REG OUTCOME® trial 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 Empagliflozin (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).^2,3

^||Hospitalisation for heart failure was a secondary CV outcome in the EMPA-REG OUTCOME® trial (HR=0.65; 95% CI: 0.50, 0.85). The primary composite outcome was death from CV causes, nonfatal MI, or nonfatal stroke, as analysed in the pooled Empagliflozin (JARDIANCE®) group vs the placebo group. The primary outcome occurred in 490 of 4687 patients (HR=0.86; 95.02% CI: 0.74, 0.99; p<0.001 for noninferiority; p=0.04 for superiority) in the pooled Empagliflozin (JARDIANCE®) group and in 282 of 2333 patients in the placebo group.³

CAD=coronary artery disease; CI=confidence interval; CV=cardiovascular; HHF=hospitalisation for heart failure; HR=hazard ratio; MACE=major adverse cardiovascular events; MI=myocardial infarction; PAD=peripheral artery disease; RRR=relative risk reduction; T2D=type 2 diabetes.

1. Verma S, Leiter LA, Zinman B, et al. Time to cardiovascular benefits of empagliflozin: a post hoc observation from the EMPAREG OUTCOME trial. ESC Heart Failure. 2021;8:2603-2607.
2. Empagliflozin (JARDIANCE®) Prescribing Information 17 March 2022.
3. 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 for certain baseline characteristics.)
4. Fitchett D, Butler J, van de Borne P, et al; EMPA-REG OUTCOME Investigators. Effects of empagliflozin on risk for cardiovascular death and heart failure hospitalization across the spectrum of heart failure risk in the EMPA-REG OUTCOME® trial. Eur Heart J. 2018;39(5):363-370.
5. 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.

Glycaemic Control:

Empagliflozin (JARDIANCE®) is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:

-Monotherapy

When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.

-Add-on Combination therapy

In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Clinical Trails).

Prevention of cardiovascular death:

Empagliflozin (JARDIANCE®) is indicated in patients with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see Clinical Trials).

To prevent cardiovascular death, Empagliflozin (JARDIANCE®) should be used in conjuction with other measures to reduce cardiovascular risk in line with the current standard of care

Hypersensitivity to the active substance of Empagliflozin (JARDIANCE®) or to any of its excipients.