Empagliflozin (Jardiance) for Type 2 Diabetes Mellitus
The recommended dose of empagliflozin for patients with type 2 diabetes mellitus is 10 mg orally once daily, taken in the morning with or without food, with the option to increase to 25 mg daily if additional glycemic control is needed. 1, 2
Dosing Recommendations
- Empagliflozin should be initiated at 10 mg once daily as the standard starting dose, providing optimal cardiovascular and glycemic benefits with a favorable safety profile 1
- Dose may be increased to 25 mg once daily if additional glycemic control is needed, though this higher dose does not provide additional cardiovascular protection 1, 2
- For cardiovascular risk reduction benefits, the 10 mg daily dose is sufficient and has demonstrated significant reduction in cardiovascular events in patients with established cardiovascular disease 1, 3
- No dose titration is needed specifically for cardiovascular or renal risk reduction benefits 1
Clinical Benefits
- Empagliflozin significantly reduces the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease 3, 2
- The EMPA-REG OUTCOME trial showed that empagliflozin reduced the composite outcome of MI, stroke, and cardiovascular death by 14% and cardiovascular death by 38% in patients with established cardiovascular disease 3
- Empagliflozin reduces the risk of hospitalization for heart failure in patients with type 2 diabetes 3, 4
- Benefits extend across the spectrum of heart failure risk, with consistent effects observed in patients at low-to-average, high, and very high risk for heart failure 4
Renal Considerations
- Assess renal function before initiating empagliflozin 2
- Do not initiate empagliflozin if eGFR is below 45 mL/min/1.73 m² 1, 2
- Discontinue empagliflozin if eGFR falls persistently below 45 mL/min/1.73 m² 2
- Empagliflozin is contraindicated in patients with severe renal impairment, end-stage renal disease, or those on dialysis 1, 2
Safety Considerations
- Consider reducing or stopping sulfonylureas/glinides or reducing total daily insulin dose by approximately 20% when initiating empagliflozin to prevent hypoglycemia 1
- Temporarily discontinue empagliflozin at least 3 days before planned surgery to prevent postoperative ketoacidosis 1, 2
- Monitor for potential adverse effects including urinary tract infections, genital mycotic infections, volume depletion, and diabetic ketoacidosis 2, 5
- Assess volume status before initiating empagliflozin, particularly in patients with renal impairment, the elderly, those with low systolic blood pressure, or those on diuretics 2
Comparative Efficacy
- When considering HbA1c, fasting plasma glucose, and total adverse events, the 25 mg dose performed best among different doses in network meta-analysis, particularly after long-term use (≥12 weeks) 6
- Unlike canagliflozin (another SGLT2 inhibitor), empagliflozin has not been associated with an increased risk of amputation or bone fractures 5
- Empagliflozin demonstrated no significant difference in the risk of cerebrovascular events compared to placebo 7
Special Considerations
- Empagliflozin is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis 2
- Beyond glucose lowering, empagliflozin exerts favorable effects on non-glycemic outcomes, including modest reductions in body weight and blood pressure 5
- The cardiovascular and renal benefits of empagliflozin appear to be largely independent of its glycemic control effects 3, 5
Common Pitfalls to Avoid
- Failing to assess renal function before initiating therapy 1, 2
- Not reducing concomitant insulin or sulfonylurea doses when starting empagliflozin, which may increase hypoglycemia risk 1
- Continuing empagliflozin during periods of reduced oral intake or fluid losses, which may increase risk of acute kidney injury 2
- Not discontinuing empagliflozin before surgical procedures, which increases ketoacidosis risk 1, 2