JARDIANCE® (Empagliflozin)
The content on this website is in relation to adult patients
Efficacy
FIRST clinically proven and licensed therapy across the LVEF spectrum1
Quick links
JARDIANCE demonstrated superiority vs placebo for the CV death/HHF composite in both HFrEF and HFpEF2,3
Indications
Heart failure
JARDIANCE® is indicated in adults for the treatment of symptomatic chronic heart failure.1
Type 2 diabetes
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 1
According to the 5.1 section of the SmPC, both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.1
Chronic kidney disease
JARDIANCE® is indicated in adults for the treatment of chronic kidney disease.1
Indications
Heart failure
JARDIANCE® is indicated in adults for the treatment of symptomatic chronic heart failure.1
Type 2 diabetes
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 1
According to the 5.1 section of the SmPC, both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.1
Chronic kidney disease
JARDIANCE® is indicated in adults for the treatment of chronic kidney disease.1
Study designs
This was a Phase III randomised, double-blind trial to evaluate efficacy and safety of once-daily JARDIANCE 10mg (n=1863) compared to placebo (n=1867), in adult patients with chronic HFrEF (NYHA class II-IV chronic symptomatic heart failure with LVEF ≤40%). Median follow up was 16 months.
This was a Phase III randomised, double-blind trial to evaluate efficacy and safety of once-daily JARDIANCE 10mg (n=2997) compared to placebo (n=2991) in adult patients with HFmrEF and HFpEF (NYHA Class II - IV chronic symptomatic heart failure with LVEF >40% and elevated NT-proBNP). Median follow up was 26 months.
JARDIANCE has demonstrated efficacy across all 3 ESC HF categories2-5
* Results from the primary endpoint of the EMPEROR-Reduced trial was time to first event of adjudicated cardiovascular death or adjudicated HHF in patients with symptomatic, chronic heart failure with reduced ejection fraction (LVEF ≤40%)
† Results from a pre-specified analysis of the primary endpoint in the EMPEROR-Preserved trial - results split by LVEF: 41-49% and ≥50%; the primary endpoint of the EMPEROR-Preserved trial was time to first event of adjudicated cardiovascular death or adjudicated HHF in patients with symptomatic, chronic heart failure with preserved ejection fraction (LVEF >40%).
EMPEROR-Reduced trial
Benefits seen as early as day 126
Pre-specified exploratory endpoint: time to first event of all-cause mortality, heart failure hospitalisation or emergent/urgent care visit for worsening heart failure:
By treating 12 patients with JARDIANCE you can prevent 1 heart failure hospitalisation2
The first secondary outcome was the occurrence of all adjudicated hospitalisations for heart failure, including first and recurrent events2:
The total number of hospitalisations for heart failure was lower in the JARDIANCE group than in the placebo group, with 388 events vs 553 events, respectively HR, 0.70; 95% CI, 0.58, 0.85; p<0.001. Based on the 30% RRR (8.8% ARR) demonstrated for hospitalisations for heart failure, 12 patients would need to have been treated with JARDIANCE to prevent one event.
EMPEROR-Preserved trial
Benefits seen as EARLY as day 187
The primary endpoint of the EMPEROR-Preserved trial was time to first event of adjudicated cardiovascular death or adjudicated HHF:
JARDIANCE demonstrated efficacy in the older patients that you often see and treat in clinical practice8
Pre-specified analysis by age of the primary outcome (composite of first heart failure hospitalisation or cardiovascular death) from the EMPEROR-Preserved trial:
JARDIANCE has proven efficacy for your HF patients across the LVEF spectrum as defined by the ESC categories9
Influence of ejection fraction on the effect of JARDIANCE on time to CV death or first HHF. Ejection fraction is analysed as a continuous variable, based on the assumption that the relationship is linear:
Abbreviations
ARR: absolute risk reduction; CI: confidence interval; CV: cardiovascular; eGFR: estimated glomerular filtration rate; ESC: european society of cardiology; HFmrEF: heart failure with mid-range ejection fraction; HFpEF: heart failure with preserved ejection fraction; 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; RRR: relative risk reduction; SoC: standard of care.
References
- JARDIANCE® (empagliflozin) Summary of Product Characteristics (SmPC). Available at: http://www.medicines.org.uk/emc/medicine/28973.
- Packer M et al. N Engl J Med. 2020;383(15):1413–1424.
- Anker SD et al. N Engl J Med. 2021;385(16):1451–1461.
- McDonagh TA et al. Eur Heart J. 2021;42(36):3599–3726.
- Anker SD et al. Nat Med (2022). https://doi.org/10.1038/ s41591-022-02041-5.
- Packer M et al. Circulation. 2021;143(4):326–336.
- Butler J et al. Eur J Heart Fail. 2022;24(2):245–248.
- Böhm M et al. J Am Coll Cardiol. 2022;80(1):1–18.
- Butler J et al. Eur Heart J. 2022;43(5):416-426.
PC-GB-108859 V2
February 2024