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EMPA-REG OUTCOME Trial: as published in <span class="desktop-break"><i>The New England</i> <span class="mobile-break"><i>Journal of Medicine</i><sup>1</sup></span></span>

EMPA-REG OUTCOME Trial: as published in The New England Journal of Medicine1

Outcome Trial Patient Icon

7020 PATIENTS

3.1 YEARS

(median)

PATIENTS STUDIED HAD:

CV Disease Icon
CV DISEASE

Evidenced by coronary artery disease, peripheral artery disease, or a history of myocardial infarction or stroke

Type 2 Diabetes Icon
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)

Clinical findings were achieved on top of cardiovascular
and type 2 diabetes standard of care medications*

CARDIOVASCULAR MEDICATIONS
81%
ACEIs/ARBs
77%
STATINS
86%
ANTIPLATELETS
83% ASPIRIN
10.5% CLOPIDOGREL
65%
BETA BLOCKERS
TYPE 2 DIABETES MEDICATIONS
74%
METFORMIN
~70%
TWO OR MORE TYPE 2 DIABETES MEDICATIONS

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.

JARDIANCE® CV Outcome Trial Icon

The JARDIANCE CV Outcome Trial was a prospective study designed to investigate CV outcomes. It was not a treat-to-target study designed to evaluate glucose lowering.

JARDIANCE CV Outcome Trial Design: 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=2345]; JARDIANCE 25 mg [N=2342]; placebo [N=2333]) 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 reduction in risk of cardiovascular events, defined by the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

ESTABLISHED CV DISEASE DEFINITIONS1

  • History of myocardial infarction >2 months prior to informed consent
  • Evidence of multi-vessel CAD, ie in ≥2 major coronary arteries or the left main coronary artery, documented by any of the following:
    • - Presence of significant stenosis: ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography)
    • - Previous revascularization (percutaneous transluminal coronary angioplasty ± stent or coronary artery bypass graft >2 months prior to consent)
    • - The combination of revascularization in one major coronary artery and significant stenosis (≥50% luminal narrowing) in another major coronary artery
  • Evidence of single-vessel CAD, ≥50% luminal narrowing during angiography (coronary or multi-slice computed tomography) not subsequently successfully revascularized, with at least 1 of the following:
    • - A positive non-invasive stress test for ischemia
    • - Hospital discharge for unstable angina ≤12 months prior to consent
  • Unstable angina >2 months prior to consent with evidence of single- or multi-vessel CAD
  • History of stroke (ischemic or hemorrhagic) >2 months prior to consent
  • Occlusive PAD documented by any of the following:
    • - Limb angioplasty, stenting, or bypass surgery
    • - Limb or foot amputation due to circulatory insufficiency
    • - Evidence of significant peripheral artery stenosis (>50% on angiography, or >50% or hemodynamically significant via non-invasive methods) in 1 limb
    • - Ankle brachial index <0.9 in ≥1 ankle

CAD=coronary artery disease; PAD=peripheral artery disease.

Percentages reflect medications taken at baseline. Type 2 diabetes medications were kept stable for the first 12 weeks. ACEIs=angiotensin-converting enzyme inhibitors;ARBs=angiotensin II receptor blockers;CV=cardiovascular;SGLT2=sodium glucose co-transporter-2.

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INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease.

JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: History of serious hypersensitivity to empagliflozin or any of the excipients in JARDIANCE; severe renal impairment, end-stage renal disease, or dialysis.

IMPORTANT SAFETY INFORMATION (continued)

WARNINGS AND PRECAUTIONS

Hypotension: Empagliflozin causes intravascular volume contraction and symptomatic hypotension may occur. Before initiating JARDIANCE, assess and correct volume status in the elderly, and in patients with renal impairment, low systolic blood pressure, or on diuretics. Monitor for hypotension.

Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and type 2 diabetes mellitus receiving SGLT2 inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. Patients who present with signs and symptoms of metabolic acidosis should be assessed for ketoacidosis, even if blood glucose levels are less than 250 mg/dL. If suspected, discontinue JARDIANCE, evaluate, and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis.

Acute Kidney Injury and Impairment in Renal Function: Empagliflozin causes intravascular volume contraction and can cause renal impairment. Acute kidney injury requiring hospitalization and dialysis have been identified in patients taking SGLT2 inhibitors, including empagliflozin; some reports involved patients younger than 65 years of age. Before initiating JARDIANCE, consider factors that may predispose patients to acute kidney injury. Consider temporary discontinuation in settings of reduced oral intake or fluid losses. Monitor patients for signs and symptoms of acute kidney injury. If it occurs, discontinue JARDIANCE and treat promptly.

Empagliflozin increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Before initiating JARDIANCE, evaluate renal function and monitor thereafter. More frequent monitoring is recommended in patients with eGFR <60 mL/min/1.73 m2. Discontinue JARDIANCE in patients with a persistent eGFR <45 mL/min/1.73 m2.

Urosepsis and Pyelonephritis: Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including empagliflozin. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate for signs and symptoms of urinary tract infections and treat promptly.

Hypoglycemia: The use of JARDIANCE in combination with insulin or insulin secretagogues can increase the risk of hypoglycemia. A lower dose of insulin or the insulin secretagogue may be required.

Genital Mycotic Infections: Empagliflozin increases the risk for genital mycotic infections, especially in patients with prior infections. Monitor and treat as appropriate.

Hypersensitivity Reactions: Discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.

Increased Low-Density Lipoprotein Cholesterol (LDL-C): Monitor and treat as appropriate.

MOST COMMON ADVERSE REACTIONS (≥5%): Urinary tract infections and female genital mycotic infections.

DRUG INTERACTIONS: Coadministration with diuretics may enhance the potential for volume depletion.

USE IN SPECIAL POPULATIONS

Pregnancy: JARDIANCE is not recommended, especially during the second and third trimesters.

Lactation: JARDIANCE is not recommended while breastfeeding.

Geriatric Use: JARDIANCE is expected to have diminished efficacy in elderly patients with renal impairment. Renal function should be assessed more frequently in elderly patients. The incidence of volume depletion-related adverse reactions and urinary tract infections increased in patients ≥75 years treated with empagliflozin.

CL-JAR-100004 12.19.17

Please see JARDIANCE Prescribing Information, including Patient Information.