Empagliflozin in Heart Failure Patients on Dialysis
No—empagliflozin is absolutely contraindicated in patients on dialysis and should not be prescribed. 1
FDA Contraindication
- The FDA label explicitly states that JARDIANCE (empagliflozin) is contraindicated in patients on dialysis. 1
- Efficacy and safety studies with empagliflozin did not enroll patients with eGFR less than 20 mL/min/1.73 m² or those on dialysis. 1
- There are insufficient data to support any dosing recommendation in patients with eGFR below 20 mL/min/1.73 m². 1
Guideline Alignment
- The 2022 AHA/ACC/HFSA heart failure guideline recommends SGLT2 inhibitors (including empagliflozin) for heart failure with preserved ejection fraction (HFpEF), but this recommendation is based on trials that enrolled patients with eGFR ≥20 mL/min/1.73 m². 2
- KDIGO 2022 guidelines recommend SGLT2 inhibitors for CKD patients with eGFR ≥20 mL/min/1.73 m², but explicitly state that dapagliflozin is contraindicated in patients already on dialysis. 3
- The same contraindication applies to empagliflozin—do not initiate in dialysis patients. 3
Clinical Trial Evidence
- The EMPEROR-Reduced and EMPEROR-Preserved trials, which demonstrated cardiovascular and heart failure benefits of empagliflozin, enrolled patients with eGFR equal to or above 20 mL/min/1.73 m² but excluded dialysis patients. 1
- A small 2025 safety study (n=17) evaluated empagliflozin 5–25 mg daily in hemodialysis patients with heart failure and found no significant adverse events over 12 weeks, but this was a short-term, single-arm study without efficacy endpoints and is insufficient to override the FDA contraindication. 4
Why the Contraindication Exists
- Empagliflozin works by inhibiting SGLT2 in the proximal tubule to increase urinary glucose excretion; in dialysis patients with minimal or no residual renal function, this mechanism cannot operate. 1
- Removal of empagliflozin by hemodialysis has not been studied, creating uncertainty about drug accumulation and safety. 1
- The cardiovascular and heart failure benefits observed in trials may not translate to dialysis patients, who were systematically excluded from all pivotal studies. 1
Common Pitfall to Avoid
- Do not extrapolate the heart failure benefits of empagliflozin seen in patients with eGFR ≥20 mL/min/1.73 m² to dialysis patients—the FDA contraindication is absolute and based on lack of safety and efficacy data in this population. 1
- If a patient already on empagliflozin progresses to dialysis, the drug must be discontinued. 3, 1
Alternative Considerations
- For heart failure management in dialysis patients, focus on guideline-directed medical therapy that has been studied in advanced CKD, including beta-blockers, mineralocorticoid receptor antagonists (with careful potassium monitoring), and diuretics for volume management. 2
- Dapagliflozin, another SGLT2 inhibitor, carries the same contraindication for dialysis patients. 3