What is the recommended use and dosage of Jardiance (empagliflozin) for patients with type 2 diabetes?

Recommended Use and Dosage of Jardiance (Empagliflozin) for Type 2 Diabetes

Jardiance (empagliflozin) is recommended at an initial dose of 10 mg once daily in the morning, taken with or without food, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. 1

Indications

• Jardiance is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 2, 1
• It is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease 2, 1
• Jardiance has demonstrated cardioprotective benefits in patients with type 2 diabetes and established cardiovascular disease, showing a 38% relative risk reduction in cardiovascular death 3

Dosing Recommendations

• Initial dose: 10 mg once daily in the morning, with or without food 2, 1
• In patients tolerating the initial dose, it may be increased to 25 mg once daily for additional glycemic control 1
• No dose titration is needed for cardiovascular or renal risk reduction; the 10 mg dose is sufficient for these benefits 2
• For patients with volume depletion, correction of this condition is recommended prior to initiation of Jardiance 1

Dose Modifications Based on Renal Function

• Assessment of renal function is recommended prior to initiation and periodically thereafter 1
• eGFR ≥45 mL/min/1.73 m²: No dose adjustment needed 2, 1
• eGFR <45 mL/min/1.73 m²: Jardiance is not recommended for glycemic control 2, 1
• Jardiance should be discontinued if eGFR is persistently <45 mL/min/1.73 m² 1
• 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 excipients 2, 1
• Severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease, or dialysis 2, 1
• Pregnancy or breastfeeding 2

Cautions and Monitoring

• Before surgery: Discontinue at least 3 days before planned surgery to prevent postoperative ketoacidosis 2
• If HbA1c is well-controlled at baseline: Consider reducing doses of sulfonylureas, glinides, or insulin (by ~20%) when starting Jardiance to prevent hypoglycemia 2
• Volume status: May contribute to intravascular volume contraction; consider stopping or reducing diuretic dose if applicable 2
• Monitor for adverse effects:
  • Genital fungal infections 2, 1
  • Urinary tract infections 2
  • Euglycemic diabetic ketoacidosis 2, 1
  • Hypotension, especially in elderly patients, those with renal impairment, low systolic blood pressure, or on diuretics 1

Cardiovascular Benefits

• In the EMPA-REG OUTCOME trial, empagliflozin demonstrated significant cardiovascular benefits in patients with type 2 diabetes and established cardiovascular disease 2, 3:
  • 14% reduction in the composite outcome of MI, stroke, and cardiovascular death 2
  • 38% reduction in cardiovascular death 3
  • 35% reduction in hospitalization for heart failure 2
  • 32% reduction in death from any cause 3
• These cardiovascular benefits were consistent across the spectrum of heart failure risk, including patients at low-to-average, high, and very high risk 4

Special Considerations

• Empagliflozin may be particularly beneficial as a preferred treatment option for patients with type 2 diabetes who also have:
  • Established cardiovascular disease 2, 5
  • Heart failure or high risk for heart failure 2, 4
  • Need for weight reduction (empagliflozin has modest weight reduction effects) 5
• The cardiovascular benefits appear to be independent of its glucose-lowering effects and may be related to prevention of heart failure in patients with a history of cardiovascular disease 6
• Recent research suggests that empagliflozin's cardiovascular benefits may be associated with beneficial changes in gut microbiota and plasma metabolites 7

Common Pitfalls to Avoid

• Failing to assess renal function before initiation and periodically during treatment 1
• Not discontinuing the medication at least 3 days before surgery, which could lead to ketoacidosis 2
• Overlooking the need to adjust doses of other antidiabetic medications when starting empagliflozin, potentially leading to hypoglycemia 2
• Not monitoring for volume depletion, especially in elderly patients or those on diuretics 2, 1
• Failing to educate patients about the signs and symptoms of ketoacidosis, which can occur even with normal blood glucose levels 1