A Review of Data from the EMPEROR Clinical Trials


Javed Butler, MD, reviews breakthrough data from the EMPEROR-Preserved trial of Jardiance (empagliflozin) tablets in HFpEF. These data established EMPEROR-Preserved as the first trial assessing morbidity and mortality in patients with HFpEF to meet its primary endpoint. Data from the EMPEROR-Reduced trial, which evaluated JARDIANCE in adults with HFrEF, will also be reviewed. In addition, Dr. Butler will discuss unmet needs and treatment guidelines in HF, as well as provide a few practical notes on initiating JARDIANCE in adults with HF. 


The content in this webinar is created independently by the sponsor. The views and/or opinions expressed in this forum do not purport to reflect the opinions or views of the HFSA or its members.

The activity A Review of Data from the EMPEROR Clinical Trials is not sponsored or endorsed by the HFSA.

The webinar is not offered in the HFSA-accredited continuing education catalog; therefore, it is ineligible for continuing education units. No committee members or representatives of the HFSA have been involved in the planning of this activity.

Learning Objective(s): 


  • Review clinical data supporting the indication for JARDIANCE to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure
  • Provide information on disease burden and unmet needs for patients affected by heart failure
  • Share information on JARDIANCE initiation and monitoring when being prescribed to reduce the risk of CV death and hospitalization for heart failure in adults with  heart failure




Javed Butler, MD, MPH, MBA

President, Baylor Scott and White Research Institute

Senior Vice President, Baylor Scott and White Health

Distinguished Professor of Medicine, University of Mississippi

Dallas, Texas






JARDIANCE is indicated: 

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure
  • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease
  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase their risk of diabetic ketoacidosis.


JARDIANCE is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR <30 mL/min/1.73 m2.  JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.




CONTRAINDICATIONS: Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred; patients on dialysis.




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. For patients who undergo scheduled surgery, consider temporarily discontinuing JARDIANCE for at least 3 days prior to surgery.


Volume Depletion: Empagliflozin can cause intravascular volume depletion which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including empagliflozin. Before initiating, assess volume status and renal function in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients or patients on loop diuretics. In patients with volume depletion, correct this condition. After initiating, monitor for signs and symptoms of volume depletion and renal function.


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. 


Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases requiring urgent surgical intervention have occurred in both females and males. Serious outcomes have included hospitalization, multiple surgeries and death. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue JARDIANCE.


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


Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with JARDIANCE (angioedema). If hypersensitivity reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.


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




Diuretics: Coadministration with diuretics may enhance the potential for volume depletion. Monitor for signs and symptoms.

Lithium: Concomitant use with lithium may decrease serum lithium concentrations. Monitor more frequently during JARDIANCE initiation and dosage changes.



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

Lactation: JARDIANCE is not recommended while breastfeeding.

Geriatric Use: JARDIANCE is expected to have diminished glycemic efficacy in elderly patients with renal impairment. Assess renal function more frequently in elderly patients. The incidence of volume depletion-related adverse reactions and urinary tract infections increased in T2D patients ≥75 years treated with empagliflozin.


CL-JAR-100130 10.17.2022


Please see JARDIANCE Prescribing Information and Medication Guide.

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