In the treatment of HF patients with LVEF >40%*
JARDIANCE protected the kidneys by slowing the decline of renal function over time†1
Included patients down to an eGFR of 20 mL/min/1.73 m2.1
JARDIANCE is approved in India by DCGI for use in patients down to eGFR 30 mL/min/1.73 m2 only.
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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. doi:10.1056/NEJMoa2107038 (EMPEROR-Preserved results and the publication’s Supplementary Appendix.)
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*
Adult patients with chronic heart failure (NYHA class II, III, or IV) and preserved ejection fraction (LVEF >40%).1
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†
The rate of decline in eGFR was a prespecified secondary outcome of the EMPEROR-Preserved trial.1
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‡
Mean baseline eGFR (CKD-EPI)EPI: JARDIANCE: 60.6 mL/min/1.73 m2; placebo: 60.6 mL/min/1.73 m2.1
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§
Background therapy: All appropriate treatments for heart failure or comorbid conditions could be initiated or altered at the discretion of the clinician.1
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CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration; eGFR=estimated glomerular filtration rate; HF=heart failure; LVEF=left ventricular ejection fraction; NYHA=New York Heart Association; SE=standard error of the mean.
In the treatment of HF patients with LVEF >40%*
JARDIANCE protected the kidneys by slowing the decline of renal function over time#1
Included patients down to an eGFR of 20 mL/min/1.73 m2.1
JARDIANCE is approved in India by DCGI for use in patients down to eGFR 30 mL/min/1.73 m2 only.
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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. doi:10.1056/NEJMoa2022190 (EMPEROR-Reduced results and the publication’s Supplementary Appendix.)
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Butler J, Zannad F, Filippatos G, Anker SD, Packer M. Ten lessons from the EMPEROR-Reduced trial. Eur J Heart Fail. 2020;22(11):1991-1993. doi:10.1002/ejhf.2009
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McDonagh TA, et al. Eur Heart J. 2021;42:3599.
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Packer M, et al. Circulation. 2021;143(4):326-336.
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*
Adult patients with chronic heart failure (NYHA class II, III, or IV) and reduced ejection fraction (LVEF ≤40%).1
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†
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). 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).1
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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%.1,2
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II
The occurrence of all HHF, including first and recurrent events, was a prespecified secondary outcome of the EMPEROR-Reduced trial.1
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¶
In addition to the RRR of all HHF, including first and recurrent events, the risk of total hospitalisations of any reason was also significantly reduced (HR=0.85, 95% CI: 0.75, 0.95).1
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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.1
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#
The rate of decline in eGFR was a prespecified secondary outcome of the EMPEROR Reduced trial.1
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**
Mean baseline eGFR (CKD-EPI): JARDIANCE: 61.8 mL/min/1.73 m2; placebo: 62.2 mL/min/1.73 m2.1
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ARNi=Angiotensin receptor neprilysin inhibitor; ARR=absolute risk reduction; CI=confidence interval; CKD EPI=Chronic Kidney Disease Epidemiology Collaboration; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HF=heart failure; HFrEF=heart failure with reduced ejection fraction; HHF= hospitalisation for heart failure; HR=hazard ratio; LVEF=left ventricular ejection fraction; NNT=number needed to treat; NYHA=New York Heart Association; RRR=relative risk reduction.
In the treatment of HF patients with LVEF >40%*
JARDIANCE has a proven safety and tolerability profile2
Rates of hypoglycaemia§ were similar between JARDIANCE and placebo in patients with or without T2D.2
In the treatment of HF patients with LVEF ≤40%II
JARDIANCE has a proven safety and tolerability profile3
Rates of hypoglycaemia§ were similar between JARDIANCE and placebo in patients with or without T2D.3
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JARDIANCE® prescribing information, version 20-Jan 2023. Boehringer Ingelheim India Pvt. Ltd.
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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. doi:10.1056/NEJMoa2107038 (EMPEROR-Preserved results and the publication’s Supplementary Appendix.)
-
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. doi:10.1056/NEJMoa2022190 (EMPEROR-Reduced results and the publication’s Supplementary Appendix.)
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*
Adult patients with chronic heart failure (NYHA class II, III, or IV) and preserved ejection fraction (LVEF >40%).2
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†
Safety analyses included all patients who had received at least 1 dose of empagliflozin or placebo. The 1 patient in the empagliflozin group who did not receive empagliflozin was excluded from the safety analyses.2
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‡
Safety analyses included all patients who had received at least 1 dose of empagliflozin or placebo. The 2 patients in the placebo group who did not receive placebo were excluded from the safety analyses.2
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§
Hypoglycaemic AEs with a plasma glucose value of ≤70 mg/dL (3.9 mmol/L) or that required assistance.2,3
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II
Adult patients with chronic heart failure (NYHA class II, III, or IV) and reduced ejection fraction (LVEF ≤40%).3
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¶
Safety analyses included all patients who had received at least 1 dose of empagliflozin or placebo. Patients who received at least 1 dose of empagliflozin or placebo were included in the safety analyses. There were 4 patients excluded from the safety analyses who did not receive placebo.3
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AE=adverse event; HF=heart failure; LVEF=left ventricular ejection fraction; NYHA=New York Heart Association; T2D=type 2 diabetes.
In non T2D patients with HF,
JARDIANCE® showed no additional safety concerns1,2
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Packer M, et al. N Engl J Med. 2020;383(15):1413-1424.
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Anker SD, et al. N Engl J Med. 2021;385(16):1451-1461.
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*
Percentages calculated using total number of patients per treatment as the denominator.
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HF=heart failure; T2D=type 2 diabetes; CV=cardiovascular; HHF=hospitalisation for heart failure; HR=hazard ratio;
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CI=confidence interval; LVEF=left ventricular ejection fraction; HFrEF=heart failure with reduced ejection fraction;
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HFpEF=heart failure with preserved ejection fraction.
PC-IN-103696 Validity till July 2025