What are the indications for Jardiance (empagliflozin)?

Indications for Jardiance (Empagliflozin)

Jardiance (empagliflozin) is indicated to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise, and to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. 1

Primary Indications

• Glycemic Control: Empagliflozin 10 mg once daily is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 2, 1
• Cardiovascular Risk Reduction: Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease 2, 1

Cardiovascular Benefits

• In the EMPA-REG OUTCOME trial, empagliflozin demonstrated a 38% relative risk reduction in cardiovascular mortality in patients with type 2 diabetes and established cardiovascular disease 3
• Empagliflozin reduced all-cause mortality by 32% in patients with type 2 diabetes and established cardiovascular disease 3
• The medication showed a 35% reduction in hospitalization for heart failure in patients with type 2 diabetes 2
• These cardiovascular benefits were observed across a range of baseline subgroups including varying HbA1c levels and different levels of renal function (down to eGFR 30 ml/min/1.73 m²) 3

Renal Benefits

• Empagliflozin demonstrated renoprotective effects in patients with type 2 diabetes and established cardiovascular disease 4
• In patients with prevalent kidney disease at baseline, empagliflozin reduced the risk of a prespecified renal composite outcome (chronic dialysis, renal transplantation, or a sustained reduction in eGFR) by 50% compared to placebo (HR 0.50; 95% CI 0.32-0.77) 2

Dosing Considerations

• The recommended starting dose is 10 mg once daily, taken in the morning, with or without food 2, 1
• The dose may be increased to 25 mg once daily for additional glycemic control if needed 1
• No dose titration is needed for cardiovascular or renal risk reduction benefits 2

Renal Function Considerations

• Assess renal function before initiating empagliflozin 1
• Do not initiate empagliflozin if eGFR is below 45 mL/min/1.73 m² 2, 1
• Discontinue empagliflozin if eGFR falls persistently below 45 mL/min/1.73 m² 1
• Empagliflozin is contraindicated in patients with severe renal impairment, end-stage renal disease, or on dialysis 2, 1

Contraindications

• History of serious hypersensitivity reaction to empagliflozin or any of the excipients in Jardiance 2, 1
• Severe renal impairment, end-stage renal disease, or dialysis 2, 1

Important Cautions and Monitoring

• Monitor for hypotension, especially in patients with renal impairment, elderly patients, those with low systolic blood pressure, or patients on diuretics 2, 1
• Assess for risk of diabetic ketoacidosis, particularly in clinical situations known to predispose to ketoacidosis 1
• Monitor for genital mycotic infections and urinary tract infections 2, 1
• Consider reducing doses of insulin or insulin secretagogues when initiating empagliflozin to reduce risk of hypoglycemia 2
• Discontinue at least 3 days before planned surgery to prevent postoperative ketoacidosis 2

Clinical Pearls

• Empagliflozin works through an insulin-independent mechanism, which carries a low inherent risk of hypoglycemia 5
• The cardiovascular benefits of empagliflozin appear to occur rapidly (within months) and are likely related to its diuretic effect and impact on heart failure prevention rather than solely through glycemic control 6
• The medication offers additional benefits beyond glucose lowering, including modest reductions in body weight and blood pressure 5