FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES
Do more to fight CV death: Add JARDIANCE as part of your standard of care

PATIENTS WERE ACTIVELY MANAGED WITH STANDARD OF CARE MEDICATIONS1†
-
CARDIOVASCULAR MEDICATIONS
including ACEIs/ARBs, aspirin, statins, and beta blockers.
-
TYPE 2 DIABETES MEDICATIONS
including metformin, insulin, DPP-4 inhibitors, GLP-1 agonists, SUs, and TZDs.
PRIMARY COMPOSITE ENDPOINT
JARDIANCE demonstrated a 14% RRR (HR=0.86 [95% Cl: 0.74-0.99]; p=0.04).
The absolute risk reduction for the composite endpoint 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]).

Number needed to treat (NNT) to prevent one CV death (median 3.1 years)1
NNT is the number of patients that need to be treated to prevent one death.
FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES
Without JARDIANCE added to their standard of care, more patients died of CV events
JARDIANCE reduced the risk of CV death early and results were consistent for both dosing strengths1
38% RRR IN CV DEATH
2.2% ARR* HR=0.62 (95% Cl: 0.49-0.77)

(95% Cl: 0.49-0.77)

- Placebo
+ CV and glucose-lowering medications (N=2333) - JARDIANCE
+ CV and glucose-lowering medications (N=4687)
FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES
Reduced risk of CV death was observed in patients with different types of established CV disease and T2D2‡
POST-HOC ANALYSIS: REDUCTION IN RISK OF CV DEATH ACROSS CVD SUBGROUPS
-
PERIPHERAL ARTERY DISEASE
-
CORONARY ARTERY DISEASE
-
HISTORY OF MI
-
HISTORY OF STROKE
- Post-hoc Analysis: CV death was analyzed in subgroups by type of CV disease at baseline. Differences between treatment groups were assessed using Cox regression analysis in patients treated with ≥1 dose of study drug. The post-hoc analysis was not designed to determine statistical significance.
- Rate of CV death (%) across CVD subgroups: All values depict JARDIANCE vs placebo, respectively. With PAD, 4.5 vs 7.5; without, 3.5 vs 5.5. With CAD, 3.7 vs 5.8; without, 3.8 vs 5.9. With history of MI, 4.6 vs 7.6; without, 2.8 vs 4.4. With history of stroke, 4.3 vs 8.0; without, 3.5 vs 5.2.
FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES
JARDIANCE demonstrated consistent reductions in CV death across A1C subgroups2§
-
A1C AT BASELINE
<7.0% -
7.0% - <8.0%
-
8.0% - <9.0%
-
≥9.0%
-
A1C CHANGE FROM BASELINE
Reduction of ≥0.3% -
Reduction of <0.3% or increase
- Post-hoc Analysis: Risk of CV death was analyzed in the placebo and pooled JARDIANCE groups according to baseline A1C and change in A1C from baseline to the last value in the trial. A Cox proportional hazards model was used to assess the differences between the treatment groups. The post-hoc analysis was not designed to determine statistical significance.
- Rate of CV death (%) across A1C subgroups: All values depict JARDIANCE vs placebo, respectively. <7.0%: 2.4 (N=297) vs 7.9 (N=127); 7.0%–<8.0%: 3.7 (N=2042) vs 6.1 (N=1029); 8.0%–<9.0%: 3.7 (N=1534) vs 5.4 (N=795); ≥9.0%: 4.2 (N=812) vs 5.5 (N=382).
- *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.
- †Type 2 diabetes medications were kept stable for the first 12 weeks.
- ‡Established CVD consisted of peripheral artery disease, coronary artery disease, or a history of MI or stroke.1
- §A pre-specified analysis included subgroups of patients with A1C <8.5% and ≥8.5%.1
AS PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE
The EMPA-REG OUTCOME Trial studied 7020 patients over a median of 3.1 years1
Patients studied had:

Established CV disease
evidenced by coronary artery disease, peripheral artery disease, or a history of myocardial infarction or stroke.

Type 2 diabetes
A1C baseline of ≥7%-≤10%
Patients were randomized to receive placebo or JARDIANCE, an SGLT2 inhibitor:
- Placebo + standard of care (N=2333)
- JARDIANCE 10 mg + standard of care (N=2345)
- JARDIANCE 25 mg + standard of care (N=2342)
These patients were receiving standard of care medications1*
ACEIs/ ARBs |
STATINS | ASPIRIN | BETA BLOCKERS |
---|---|---|---|
81% | 77% | 83% | 65% |
METFORMIN | TWO OR MORE TYPE 2 DIABETES MEDICATIONS |
---|---|
74% | ~70% |
Investigators were encouraged to manage CV risk factors and blood glucose by actively adjusting all medications in order to achieve appropriate treatment goals in all treatment groups.
- *Percentages reflect medications taken at baseline. Type 2 diabetes medications were kept stable for the first 12 weeks.
ACROSS MULTIPLE TRIALS
JARDIANCE has a demonstrated safety and tolerability profile
PLACEBO | JARDIANCE* | |
---|---|---|
Urinary tract infection | 18.1% | 18.0% |
Genital mycotic infection | 1.8% | 6.4% |
PLACEBO
(N=995)
|
JARDIANCE 10 MG
(N=999)
|
JARDIANCE 25 MG
(N=977)
|
|
---|---|---|---|
Urinary tract infection | 7.6% | 9.3% | 7.6% |
UTIs: Males | 3.2% | 3.6% | 4.1% |
UTIs: Females | 16.6% | 18.4% | 17.0% |
Female genital mycotic infections | 1.5% | 5.4% | 6.4% |
Upper respiratory tract infection | 3.8% | 3.1% | 4.0% |
Increased urination | 1.0% | 3.4% | 3.2% |
Dyslipidemia | 3.4% | 3.9% | 2.9% |
Arthralgia | 2.2% | 2.4% | 2.3% |
Male genital mycotic infections | 0.4% | 3.1% | 1.6% |
Nausea | 1.4% | 2.3% | 1.1% |
PLACEBO |
JARDIANCE 10 MG |
JARDIANCE 25 MG |
|
---|---|---|---|
Lower limb amputation‡ | 1.8% | 1.8% | 2.0% |
Bone fracture | 3.9% | 3.9% | 3.7% |
JARDIANCE as monotherapy or add-on to metformin demonstrated similar hypoglycemia rates compared with placebo
PLACEBO
(N=229)
|
JARDIANCE
(N=224)
10 mg
|
JARDIANCE
(N=223)
25 mg
|
|
---|---|---|---|
Overall (plasma glucose ≤70 mg/dL) | 0.4% | 0.4% | 0.4% |
Severe (requiring assistance regardless of blood glucose) | 0% | 0% | 0% |
PLACEBO
(N=206)
|
JARDIANCE
(N=217)
10 mg
|
JARDIANCE
(N=214)
25 mg
|
|
---|---|---|---|
Overall (plasma glucose ≤70 mg/dL) | 0.5% | 1.8% | 1.4% |
Severe (requiring assistance regardless of blood glucose) | 0% | 0% | 0% |
When used in combination with sulfonylurea or insulin, hypoglycemia rates were higher
PLACEBO
(N=225)
|
JARDIANCE
(N=224)
10 mg
|
JARDIANCE
(N=217)
25 mg
|
|
---|---|---|---|
Overall (plasma glucose ≤70 mg/dL) | 8.4% | 16.1% | 11.5% |
Severe (requiring assistance regardless of blood glucose) | 0% | 0% | 0% |
PLACEBO
(N=170)
|
JARDIANCE
(N=169)
10 mg
|
JARDIANCE
(N=155)
25 mg
|
|
---|---|---|---|
Overall (plasma glucose ≤70 mg/dL) | 20.6% | 19.5% | 28.4% |
Severe (requiring assistance regardless of blood glucose) | 0.0% | 0.0% | 1.3% |
- *Pooled data from JARDIANCE 10 mg and JARDIANCE 25 mg.1
- †Adverse events, excluding hypoglycemia, reported in pooled, placebo-controlled clinical studies in ≥2% of patients treated with JARDIANCE and greater than placebo.
- ‡In the EMPA-REG OUTCOME Trial, procedures such as amputations were classified as therapeutic procedures and were not routinely captured as adverse events. Post-hoc analyses of amputations in the clinical trial database were performed by searching concomitant therapies, comment fields for adverse event listings, and case narratives.2
- §Basal insulin study: No insulin adjustment during the first 18 weeks.
- ||Orals included metformin and/or a sulfonylurea.
- AE=adverse event; UTI=urinary tract infection.
The 2020 American Diabetes Association® Standards of Care recommends SGLT2 inhibitors, which includes empagliflozin as a 2nd-line treatment1 option when adult patients with T2D have established CV disease - independent of baseline A1C
The ADA® Standards of Care recommends an SGLT2 inhibitor as a 2nd-line treatment option when A1C is above target and when there is a need for weight loss1*
Both the ADA® Standards of Care and the American College of Cardiology Expert Consensus Decision Pathway recommend SGLT2 inhibitors to help manage cardiovascular outcomes.1,2
*JARDIANCE is not indicated for weight loss or blood pressure reduction.³
ACC=American College of Cardiology;
ADA=American Diabetes Association;
SGLT2=sodium glucose co-transporter-2.
See the recommendation at www.diabetes.org.