NOW APPROVED FOR CKD!
MAKE PROTECTION
YOUR SUPERPOWER
JARDIANCE® protects by reducing risk for
adult patients with CKD*1,2, HF†3,4 and T2D+CVD.‡5
![MAKE PROTECTION
YOUR SUPERPOWER](/products/jardiance/sites/default/files/2023-11/Hero-Primary%20Banner.png)
In the treatment of patients with LVEF ≤ 40%§
EMPEROR-Reduced -
JARDIANCE® reduced the risk of CV death or HHF†3
![EMPEROR-Reduced -JARDIANCE® reduced the risk of CV death or HHF EMPEROR-Reduced -JARDIANCE® reduced the risk of CV death or HHF](/products/jardiance/sites/default/files/2023-11/EMPEROR-Reduced_-JARDIANCE%C2%AE_reduced_the_risk_of_CV_death_or_HHF.jpeg)
In the treatment of patients with LVEF ≤ 40%§
JARDIANCE® reduced the risk of first
and recurrent HHF||**3
![JARDIANCE® reduced the risk of first and recurrent HHF JARDIANCE® reduced the risk of first and recurrent HHF](/products/jardiance/sites/default/files/2023-11/JARDIANCE%C2%AE_reduced_the_risk_of_first_and_recurrent_HHF.jpeg)
In the treatment of patients with LVEF ≤ 40%§
JARDIANCE® protected the kidneys by slowing the decline of renal function over time††3
![JARDIANCE® protected the kidneys by slowing the decline of renal function over time JARDIANCE® protected the kidneys by slowing the decline of renal function over time](/products/jardiance/sites/default/files/2023-11/JARDIANCE%C2%AE_protected_the_kidneys_by_slowing_the_decline_of_renal_function_over_time.png)
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GUIDELINE RECOMMENDATIONS
![DOSING RECOMMENDATIONS DOSING RECOMMENDATIONS](/products/jardiance/sites/default/files/2023-11/dosing-recommendations.png)
DOSING RECOMMENDATIONS
![SAFETY & TOLERABILITY PROFILE SAFETY & TOLERABILITY PROFILE](/products/jardiance/sites/default/files/2023-11/safety-tolerability-profile.png)
SAFETY & TOLERABILITY PROFILE
Indication & Footnotes
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
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
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‡
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
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§
Adult patients with chronic heart failure (NYHA class II, III, or IV) and reduced ejection fraction (LVEF ≤ 40%).3
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¶
ARR calculation: JARDIANCE® number of patients with events 361/total number of patients 1863=19.4%; placebo number of patients with events 462/total number of patients 1867=24.7%; 24.7%–19.4%=5.3%. NNT=1/ARR.3
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#
Standard of care: All patients received appropriate treatments for heart failure, including diuretics, inhibitors of the renin-angiotensin system and neprilysin, beta blockers, mineralocorticoid receptor antagonists and, when indicated, cardiac devices.3
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||
The occurrence of all HHF, including first and recurrent events, was a prespecified secondary outcome of the EMPEROR-Reduced trial.3
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**
In addition to the RRR of all HHF, including first and recurrent events, the risk of total hospitalisations for any reason was also significantly reduced (HR=0.85, 95% CI: 0.75, 0.95).3
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††
The rate of decline in eGFR was a prespecified secondary outcome of the EMPEROR-Reduced trial.3
ARR=absolute risk reduction; 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; T2D=type 2 diabetes.
References
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JARDIANCE® [summary of product characteristics]. Ingelheim am Rhein, Germany; Boehringer Ingelheim International GmbH.
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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.)
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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.)
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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.)
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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.)