JARDIANCE® (Empagliflozin)

The content on this website is in relation to adult patients

 

Efficacy

Jardiance reduces mortality in patients with T2D and CVD1

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The EMPA-REG OUTCOME® trial demonstrated JARDIANCE significantly reduces the risk of mortality and CV events in T2D patients with CVD vs placebo1

Reduced mortality infographic JARDIANCE® (empagliflozin)
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Data based on pooled doses of JARDIANCE (10mg and 25mg) versus placebo.

* Data from EMPA-REG OUTCOME trial: randomised, double-blind, placebo-controlled trial (N=7020). Patients with T2D and CVD were randomised to receive JARDIANCE 10mg (N=2345) or JARDIANCE 25mg (N=2342) or placebo (N=2333) once daily, on top of standard of care. Primary endpoint of 3P-MACE, defined as a primary composite of death from CV causes, non-fatal myocardial infarction, or non-fatal stroke.

CV death and all-cause mortality were pre-defined, adjudicated, exploratory endpoints in the EMPA-REG-OUTCOME trial.1

The efficacy for preventing cardiovascular mortality has not been conclusively established in patients using JARDIANCE concomitantly with DPP-4 inhibitors or in black patients because the representation of these groups in the EMPA-REG OUTCOME® study was limited.

Click here for details on the EMPA-REG OUTCOME® trial

Reduce the risk of CV Death EARLY with JARDIANCE® vs placebo in T2D with CVD patients1,3-6

CV death chart JARDIANCE® (empagliflozin)
Click here for details on the EMPA-REG OUTCOME® trial

For every 39 People treated with JARDIANCE®, one death from any cause is prevented1‡‡

Reduced death any cause infographic JARDIANCE® (empagliflozin)
 

‡‡ These numbers cannot be extrapolated to patient populations with other clinical characteristics.

Click here for details on the EMPA-REG OUTCOME® trial

JARDIANCE protects the kidney by reducing the risk of incident or worsening nephropathy7

Reduced risk incident infographic JARDIANCE® (empagliflozin)
Reduced risk incident infographic JARDIANCE® (empagliflozin)

In a post-hoc analysis of the EMPA-REG OUTCOME® trial, JARDIANCE was associated with slower progression of kidney disease and lower rates of clinically relevant renal events than was placebo when added to standard care.7

Incident or worsening nephropathy, defined as progression to macroalbuminuria (urinary albumin-to-creatinine ratio, >300mg of albumin per gram of creatinine); a doubling of the serum creatinine level, accompanied by an eGFR of ≤45mL per minute per 1.73m2; the initiation of renal-replacement therapy; or death from renal disease.7

If you would like to learn more about EMPA-REG OUTCOME® trial, please click here. If you would like to learn more about JARDIANCE® for the treatment of chronic kidney disease, please click here for details on the EMPA-KIDNEY trial.

 

Help your T2D patients to achieve multiple metabolic benefits with JARDIANCE2

Reduced HbA1c infographic JARDIANCE® (empagliflozin)

* In a 24-week, double-blind, placebo-controlled study of 637 patients with type 2 diabetes, the efficacy and safety of JARDIANCE 10mg (n=217) and JARDIANCE 25mg (n=213) as add-on therapy to metformin ≥1500mg were evaluated vs placebo added to metformin (n=207). The primary endpoint was adjusted mean change (SE) from baseline in HbA1c (%) at 24 weeks; change from baseline in weight and blood pressure at week 24 were key secondary and exploratory endpoints, respectively.2

† Adjusted mean changes from baseline HbA1c 7.9% were -0.13% for placebo (n=207), -0.7% for JARDIANCE 10mg (n=217) and -0.77% for JARDIANCE 25mg (n=213), respectively. Difference from baseline vs placebo (adjusted mean) was -0.6 % for both JARDIANCE 10mg and 25mg; p<0.001 vs placebo for both doses.2

# Adjusted mean changes of -0.5kg reduction in body weight from baseline 79.7kg for placebo (n=207), -2.1kg from baseline 81.6kg for JARDIANCE 10mg (n=217), and -2.5kg from baseline 82.2kg for JARDIANCE 25mg (n=213), p<0.001 vs placebo for both doses.2

†† Change in systolic blood pressure from baseline at 24 weeks: JARDIANCE 10mg -4.5mmHg (n=217), JARDIANCE 25mg -5.2mmHg (n=213), vs placebo -0.4mmHg (n=207). Mean baseline value for JARDIANCE 10mg -129.6mmHg, 25mg -130.0mmHg and placebo -128.6mmHg (p<0.001 vs placebo for both doses).2

Abbreviations

3P-MACE: 3-point major adverse cardiovascular events; ARR: absolute risk reduction; BMI: body mass index; BP: blood pressure; CI: confidence interval; CV: cardiovascular; CVD: cardiovascular disease; eGFR: estimated glomerular filtration rate; HbA1c: haemoglobin A1c; HR: hazard ratio; NNT: number needed to treat; RRR: relative risk reduction; SBP: systolic blood pressure; SOC: standard of care; T2D: type 2 diabetes mellitus.

References
  1. Zinman B et al. N Engl J Med 2015;373:2117–2128.
  2. Haring HU, et al. Diabetes Care. 2014;37:1650–1659.
  3. JARDIANCE® (empagliflozin) Summary of Product Characteristics (SmPC). Available at: http://www.medicines.org.uk/emc/medicine/28973.
  4. Inzucchi SE, et al. Circulation. 2018;138:1904–1907.
  5. Fitchett D, et al. J Am Coll Cardiol. 2018;71:364–367.
  6. Verma S, et al. Diabetes. 2020:69(Suppl 1):28-OR.
  7. Wanner C, et al. N Engl J Med. 2016;375:323–334.

PC-GB-108851 V2

February 2024

Reporting adverse events

Adverse events should be reported. Reporting form and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).

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