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For Healthcare Professionals

JARDIANCE®

Efficacy

Type 2 diabetes mellitus

For adults with type 2 diabetes, along with diet and exercise

EMPA-REG MET Trial is a randomized, double-blind, placebo-controlled, parallel-group, Phase III study, evaluating the efficacy and safety of JARDIANCE® (10 mg and 25 mg) once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control despite treatment with metformin ≥1500 mg alone. Six hundred thirty-seven treated patients received placebo + metformin (N=207), JARDIANCE® 10 mg + metformin (N=217), or JARDIANCE® 25 mg + metformin (N=213). The primary endpoint was HbA1c change from baseline. Weight change and blood pressure change from baseline were secondary endpoints.1

 

JARDIANCE® reduced A1C as early as 24 weeks in a placebo-controlled, glucose-lowering study of JARDIANCE® as add-on to metformin1

Reductions from baseline in HbA1c level at week 24 were significantly greater in the JARDIANCE® groups than in the placebo group.

Reductions-from-baseline-in-HbA1c-level-at-week-24-were-significantly-greater-in-the-JARDIANCE-groups-than-in-the_renew

JARDIANCE® significantly reduced weight as early as 24 weeks in a placebo-controlled, glucose-lowering study of JARDIANCE® as add-on to metformin1

Both doses of JARDIANCE® resulted in significant reductions in body weight compared with placebo. The differences of adjusted means versus placebo were -1.63 kg for JARDIANCE® 10 mg and -2.01 kg for JARDIANCE® 25 mg; P < 0.001 for both doses.

JARDIANCE-significantly-reduced-weight-as-early-as-24-weeks-in-a-placebo-controlled-glucose-lowering-study-of_renew

JARDIANCE® reduced systolic blood pressure (SBP) as early as 24 weeks in a placebo-controlled, glucose-lowering study of JARDIANCE® as add-on to metformin§1

JARDIANCE® therapy was associated with significantly greater reductions from baseline in SBP and diastolic blood pressure (DBP) at week 24 than placebo.

JARDIANCE-reduced-systolic-blood-pressure-SBP-as-early-as-24-weeks-in-a-placebo-controlled-glucose-lowering_renew

For adults with established CV disease and type 2 diabetes

EMA-REG OUTCOME is a randomized, double-blind, parallel-group trial comparing the risk of experiencing a major adverse cardiovascular event between JARDIANCE® and placebo when these were added to and used concomitantly with standard of care treatments for type 2 diabetes and cardiovascular disease. A total of 7020 patients were treated (JARDIANCE® 10 mg [N=2,345]; JARDIANCE® 25 mg [N=2,342]; placebo [N=2,333]) and followed for a median of 3.1 years. All patients had established atherosclerotic cardiovascular disease at baseline, including one or more of the following: a documented history of coronary artery disease, peripheral artery disease, myocardial infarction, or stroke. The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent myocardial infarction), or nonfatal stroke.2

Heart failure

JARDIANCE® reduced the relative risk of CV death by 38% on top of standard of care medications2

JARDIANCE® demonstrated a 14% relative risk reduction (RRR) in reducing the composite endpoint (HR=0.86 [95% CI: 0.74-0.99]; p=0.04); the absolute risk reduction was 1.6%. There was no change in risk of nonfatal MI (HR=0.87 [95% CI: 0.70-1.09]) or nonfatal stroke (HR=1.24 [95% CI: 0.92-1.67]); the 14% RRR in CV events was due to a reduction in the risk of CV death (HR=0.62 [95% CI: 0.49-0.77]).

JARDIANCE-reduced-the-relative-risk-of-CV-death-by-38-on-top-of-standard-of-care-medications_renew

Patients were actively managed with standard of care medications, including ACEIs/ARBs, statins, antiplatelets, and beta blockers.

 

Groups ACEIs/ARBs Statins Acetylsalicylic acid Clopidogrel Beta blockers
Placebo (n=2,333) 80.1% 76.0% 82.6% 10.7% 64.2%
JARDIANCE® (n=4,687) 81.0% 77.4% 82.7% 10.5% 65.2%

Reduced risk of CV death by JRADIANCE® was observed in patients with different types of established CV diseases2

A consistent benefit of JARDIANCE® versus placebo on death from cardiovascular causes across all subgroups.

Reduced-risk-of-CV-death-by-JRADIANCE-was-observed-in-patients-with-different-types-of-established-CV-diseases_renew

For adults with symptomatic chronic heart failure with reduced ejection fraction

In the EMPEROR-Reduced® trial, a randomized, double-blind, parallel-group, placebo-controlled study of 3,730 patients with heart failure and reduced ejection fraction (HFrEF) (with or without diabetes), the efficacy and safety of JARDIANCE® 10 mg (n=1,863) was evaluated vs placebo (n=1,867). All the patients were receiving 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. The primary composite endpoint was a composite of CV death or hospitalization for heart failure (HHF), analyzed as time to the first event. The first secondary outcome was the occurrence of all adjudicated hospitalizations for heart failure, including first and re- current events. The second secondary outcome was the rate of the decline in the estimated GFR during double-blind treatment.3

 

JARDIANCE® reduced the relative risk of CV death or HHF by 25%3

The primary composite outcome of CV death or HHF occurred in 361 patients (19.4%) in the JARDIANCE® group and in 462 patients (24.7%) in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001).

JARDIANCE-reduced-the-relative-risk-of-CV-death-or-HHF-by-25_renew

JARDIANCE® reduced the risk regardless of baseline HF medications3

The effect of JARDIANCE® on the primary outcome was consistent in patients taking or not taking neprilysin inhibitor or mineralocorticoid receptor antagonist at baseline.

 

Groups Beta blockers ACEIs/ARBs ARNI MRA
Placebo (n=1,867) 94.7% 68.9% 20.7% 72.6%
JARDIANCE® (n=1,863) 94.7% 70.5% 18.3% 70.1%
JARDIANCE-baseline-HF-medications

JARDIANCE® reduced the risk regardless of diabetes status3

The effect of JARDIANCE® on the primary outcome was consistent across prespecified subgroups, including patients with diabetes and those without diabetes at baseline.

JARDIANCE-reduced-the-risk-regardless-of-diabetes-status_renew

JARDIANCE® reduced the relative risk of first and recurrent HHF by 30%3

The total number of HHF was lower in the JARDIANCE® group than in the placebo group, with 388 events and 553 events, respectively (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).

JARDIANCE-reduced-the-relative-risk-of-first-and-recurrent-HHF-by-30_renew

JARDIANCE® provided kidney protection in patients with HFrEF with a 4 times slower annual decline in eGFR3

The rate of the decline in the estimated glomerular filtration rate (eGFR) over the duration of the double-blind treatment period was slower in the JARDIANCE® group than in the placebo group (–0.55 ml/min/1.73 m2/year vs. –2.28 ml/min/1.73 m2/year), for a between-group difference of 1.73 ml/min/1.73 m2/year (95% CI, 1.10 to 2.37; P<0.001).

JARDIANCE-provided-kidney-protection-in-patients-with-HFrEF-with-a-4-times-slower-annual-decline-in-eGFR_renew

Footnotes:

  • * Adjusted mean changes of -0.13% from a baseline of 7.9% for placebo (n=207), -0.70% from a baseline of 7.9% for JARDIANCE® 10 mg (n=217), and -0.77% from a baseline of 
    7.9% for JARDIANCE® 25 mg (n=213). Difference from placebo + metformin (adjusted mean) was -0.6% for both 
    JARDIANCE® 10 mg and 25 mg; p<0.001 vs placebo for both doses.
  • † An additional 69 patients with HbA1c level > 10% received open-label JARDIANCE® 25 mg, and 58 of these patients (84.1%) completed the 24-week treatment period.
  • ‡ Adjusted mean changes of -0.5% (-0.9 lb) from a baseline of 176 lb for placebo (n=207), -2.5% (-4.5 lb) from a baseline of 181 lb for JARDIANCE® 10 mg (n=217), and -2.9% 
    (-5.2 lb) from a baseline of 181 lb for JARDIANCE® 25 mg (n=213); p<0.0001 vs placebo.
  • § JARDIANCE® is not indicated for systolic blood pressure reduction. Change in systolic blood pressure from baseline was a secondary endpoint.
  • ¶ Placebo-corrected mean changes of -4.1 mm Hg from a baseline of 129.6 mm Hg for JARDIANCE® 10 mg and -4.8 mm Hg from a baseline of 130.0 mm Hg for JARDIANCE® 
    25 mg; JARDIANCE® vs placebo p<0.001 for both doses.
  • || Absolute rates for CV death: 5.9% placebo vs 3.7% JARDIANCE®.
  • ** Pooled data from JARDIANCE® 10 mg and JARDIANCE® 25 mg; similar magnitude of reduction was shown with both doses.
  • †† 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.
  • ‡‡ Predefined subgroups in the EMPEROR-Reduced® trial. ARR calculations: Without type 2 diabetes—JARDIANCE® number of patients with events 161/total number of patients 
    936=17.2%; placebo number of patients with events 197/total number of patients 938=21.0%; 21.0% - 17.2%=3.8%. With type 2 diabetes—JARDIANCE® number of patients with 
    events 200/total number of patients 927=21.6%; placebo number of patients with  events 265/total number of patients 929=28.5%; 28.5% - 21.6%=6.9%.
  • §§ Baseline eGFR: JARDIANCE®: 61.8 mL/min/1.73 m2; placebo: 62.2 mL/min/1.73 m2.
  • ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; ARNI, angiotensin receptor neprilysin inhibitor; ARR, absolute risk reduction; 
    CI, confidence interval; CV, cardiovascular; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; HFrEF, heart failure with reduced ejection fraction; 
    HHF, hospitalisation for heart failure; HR, hazard ratio; LVEF, left ventricular ejection fraction; MI, myocardial infarction; MRA, mineralocorticoid receptor antagonist; NNT, number 
    needed to treat; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; NYHA, New York Heart Association; RRR, relative risk reduction; SBP, systolic blood pressure; 
    SE, standard error of the mean; SGLT2, sodium-glucose cotransporter.

References:

  1. Häring HU, et al. Diabetes Care. 2014;37(6):1650-1679.

  2. Zinman B et al. N Engl J Med. 2015;373(22):2117-2128.

  3. Packer M, et al. N Engl J Med. 2020;383(15):1413-1424.

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