Is it within the standard of care to prescribe Jardiance (Empagliflozin) to patients with impaired renal function, specifically a Glomerular Filtration Rate (GFR) between 20-29?

Prescribing Jardiance (Empagliflozin) for Patients with GFR 20-29 mL/min/1.73 m²

According to the FDA label, prescribing Jardiance (empagliflozin) for patients with a GFR in the 20-29 range is not within the standard of care as it should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m².1

Current FDA Recommendations

The FDA label for Jardiance clearly states:

• Jardiance should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m²
• Jardiance should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m²
• Patients with severe renal impairment are contraindicated for Jardiance use1

Emerging Evidence vs. Current Labeling

Despite the FDA label restrictions, recent evidence suggests potential benefits of SGLT2 inhibitors in patients with lower GFR:

• The 2022 ADA/KDIGO consensus report indicates that some SGLT2 inhibitors with proven kidney or cardiovascular benefit can be recommended for patients with T2D, CKD, and eGFR ≥20 ml/min/1.73 m²2
• Specifically, dapagliflozin may be initiated with eGFR ≥25 mL/min/1.73 m² and continued until dialysis2
• However, empagliflozin specifically is not recommended for use with eGFR <45 mL/min/1.73 m²2

Important Clinical Considerations

When considering SGLT2 inhibitors in patients with reduced renal function:

1. Glycemic efficacy vs. cardiorenal benefits:

   • Glucose-lowering efficacy diminishes significantly as eGFR declines2
   • Cardiovascular and renal benefits may persist at lower eGFR levels3

2. Safety concerns in severe CKD:

   • Increased risk of volume depletion and hypotension1
   • Risk of acute kidney injury
   • Potential for electrolyte abnormalities

3. Alternative SGLT2 inhibitors:

   • If kidney or cardiovascular protection is the goal in a patient with GFR 20-29, consider dapagliflozin which has specific labeling allowing initiation at eGFR ≥25 mL/min/1.73 m²2

Clinical Decision Algorithm

For patients with T2D and GFR 20-29 mL/min/1.73 m²:

1. Do not initiate empagliflozin (Jardiance) - this would be outside the FDA-approved indication1

2. Consider alternatives:

   • For glycemic control: GLP-1 receptor agonists (dulaglutide, liraglutide, semaglutide) which require no dose adjustment in CKD2
   • For cardiorenal protection: dapagliflozin may be considered if eGFR ≥25 mL/min/1.73 m²2

3. For patients already on empagliflozin whose GFR has declined to 20-29:

   • According to the FDA label, empagliflozin should be discontinued1
   • However, emerging evidence suggests potential benefits of continuing therapy until dialysis for cardiorenal protection3
   • This represents a clinical dilemma where the physician must weigh FDA guidance against emerging evidence

Conclusion

While emerging evidence suggests potential benefits of SGLT2 inhibitors in patients with lower GFR levels, the current FDA label for empagliflozin (Jardiance) specifically prohibits initiation in patients with eGFR <45 mL/min/1.73 m². Therefore, prescribing Jardiance for patients with a GFR in the 20-29 range would not be considered within the standard of care based on current labeling.