Empagliflozin Dosing for Nondiabetics with CKD and Heart Failure
The recommended dose of empagliflozin for nondiabetic patients with CKD and heart failure is 10 mg once daily, regardless of diabetes status. 1, 2
Efficacy in Nondiabetic Patients
- Empagliflozin 10 mg daily has demonstrated significant cardiovascular and renal benefits in patients with heart failure, regardless of diabetes status 1
- In the EMPEROR-Preserved trial, empagliflozin reduced the primary outcome of cardiovascular death or hospitalization for heart failure by 21% in patients with heart failure with preserved ejection fraction (HFpEF), with consistent effects in both diabetic and nondiabetic patients 1
- Approximately 50% of subjects in EMPEROR-Preserved did not have diabetes at baseline, yet showed similar benefits from empagliflozin therapy 1, 2
- The EMPEROR-Reduced trial showed that empagliflozin reduced the risk of cardiovascular death or heart failure hospitalization regardless of baseline kidney function 3
Renal Benefits and Dosing Considerations
- Empagliflozin has shown significant renal protective effects across the spectrum of kidney function, including in patients with eGFR as low as 20 mL/min/1.73 m² 1, 3
- The medication slows the decline in eGFR in both patients with and without chronic kidney disease 3
- Empagliflozin reduced the risk of composite kidney outcomes similarly in patients with and without CKD (HR=0.53 and HR=0.46, respectively) 3
- The benefits of empagliflozin on cardiovascular and kidney outcomes were consistent across all KDIGO risk categories 4
Safety Profile
- Empagliflozin is well-tolerated in patients with CKD, with a safety profile consistent with that observed in the overall trial populations 5, 3
- The most common adverse effect specific to SGLT2 inhibitors is genital mycotic infections, which occur more frequently with empagliflozin compared to placebo across all KDIGO risk categories 4
- No increased risk of hypoglycemic events was observed in nondiabetic patients compared to placebo 2
Clinical Application
- For nondiabetic patients with CKD and heart failure, initiate empagliflozin at 10 mg once daily 1, 2
- No dose adjustment is required based on kidney function for cardiovascular or renal protection, even in patients with eGFR as low as 20 mL/min/1.73 m² 1, 3
- While the glucose-lowering efficacy decreases with declining renal function, the cardiovascular and renal benefits are preserved at lower eGFR levels 6
- Consider temporarily withholding empagliflozin for at least 3 days prior to major surgery or procedures requiring prolonged fasting 6
Monitoring Recommendations
- Assess renal function prior to initiation and periodically thereafter 6
- Evaluate volume status before starting empagliflozin, and correct volume depletion if present 6
- Monitor for potential adverse effects including genital mycotic infections, urinary tract infections, volume depletion, and euglycemic diabetic ketoacidosis 6, 4
Empagliflozin has demonstrated significant cardiovascular and renal benefits in both diabetic and nondiabetic patients with heart failure and CKD, with a consistent dose of 10 mg daily showing efficacy across various patient populations and kidney function levels.