What is the class recommendation for Jardiance (Empagliflozin) in Chronic Cardiovascular Disease (CCD) management?

Class Recommendation for Jardiance (Empagliflozin) in Chronic Cardiovascular Disease Management

Empagliflozin (Jardiance) has a Class I recommendation for patients with chronic coronary disease (CCD) who have type 2 diabetes, and is recommended to reduce cardiovascular events. 1

Recommendations Based on Patient Population

For Patients with Type 2 Diabetes and Cardiovascular Disease:

• Empagliflozin is recommended (Class I) in patients with type 2 diabetes and established cardiovascular disease to reduce cardiovascular events 1
• Empagliflozin specifically has a Class I recommendation to reduce the risk of death in patients with type 2 diabetes and cardiovascular disease 1
• The recommendation is based on strong evidence showing significant reduction in cardiovascular mortality (38% relative risk reduction) and all-cause mortality (32% relative risk reduction) in the EMPA-REG OUTCOME trial 2, 3

For Patients with Heart Failure:

• For patients with CCD and heart failure with LVEF ≤40%, SGLT2 inhibitors including empagliflozin have a Class I recommendation to reduce the risk of cardiovascular death and heart failure hospitalization, regardless of diabetes status 1
• For patients with CCD and heart failure with LVEF >40%, empagliflozin has a Class IIa recommendation to decrease heart failure hospitalizations and improve quality of life, irrespective of diabetes status 1
• SGLT2 inhibitors including empagliflozin are recommended (Class I) to lower risk of heart failure hospitalization in patients with diabetes 1

For Patients with Chronic Kidney Disease:

• SGLT2 inhibitors including empagliflozin are recommended (Class I) to reduce progression of diabetic kidney disease 1
• Empagliflozin has shown consistent benefits on cardiovascular and kidney outcomes across different clinical phenotypes of diabetic kidney disease 4

Dosing and Administration

• The recommended starting dose is 10 mg once daily, which may be increased to 25 mg once daily if tolerated 5
• Empagliflozin should not be initiated in patients with eGFR less than 45 mL/min/1.73 m² 5
• No dose adjustment is needed for patients with eGFR ≥45 mL/min/1.73 m² 5

Clinical Considerations and Cautions

• Empagliflozin can cause intravascular volume contraction, so assessment for volume depletion before initiation is recommended, particularly in elderly patients or those on diuretics 5
• Monitor for signs of ketoacidosis, genital mycotic infections, and hypotension after initiating therapy 5, 3
• The benefits of empagliflozin extend beyond glycemic control, with favorable effects on blood pressure and body weight 6

Summary of Evidence Quality

• The Class I recommendation for empagliflozin in patients with type 2 diabetes and cardiovascular disease is based on high-quality evidence (Level A) from randomized controlled trials 1
• The Class IIa recommendation for empagliflozin in heart failure with LVEF >40% is supported by moderate-quality evidence 1
• The evidence supporting empagliflozin's cardiovascular benefits comes primarily from the landmark EMPA-REG OUTCOME trial, which was the first study to show significant reduction of cardiovascular endpoints with a glucose-lowering agent 2, 3