From the Guidelines
No, patients with impaired renal function requiring dialysis should not take Jardiance (empagliflozin) as it is contraindicated in patients on dialysis [ 1, 1].
Key Points
- The contraindication for empagliflozin in patients on dialysis is due to the lack of evidence on its safety and efficacy in this population [ 1, 1].
- The estimated glomerular filtration rate (eGFR) cutoff for empagliflozin is <45 mL/min/1.73 m2, below which its use is not recommended for glycemic control, and <30 mL/min/1.73 m2 is considered a contraindication [ 1].
- Patients with end-stage renal disease (ESRD) or severe renal impairment should not be prescribed empagliflozin [ 1, 1].
Important Considerations
- The American College of Cardiology expert consensus decision pathway recommends against the use of empagliflozin in patients with ESRD or those on dialysis [ 1, 1].
- The FDA-approved labeling indications for empagliflozin also state that it is contraindicated in patients on dialysis 1.
- Healthcare providers should exercise caution when prescribing empagliflozin to patients with renal impairment and closely monitor their kidney function [ 1, 1].
From the FDA Drug Label
JARDIANCE is contraindicated in patients: with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5. 7)]. on dialysis [see Use in Specific Populations (8.6)]. JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
Patients with impaired renal function requiring dialysis should not take Jardiance (empagliflozin), as it is contraindicated in these patients 2.
From the Research
Empagliflozin Use in Patients with Impaired Renal Function
- Empagliflozin, also known as Jardiance, has been studied in patients with impaired renal function, including those requiring dialysis 3, 4, 5, 6.
- The EMPEROR-Preserved trial found that empagliflozin improved clinical outcomes in patients with heart failure, including those with impaired renal function, with a baseline eGFR as low as 20 ml/min/1.73 m2 3.
- The EMPEROR-Reduced trial also found that empagliflozin reduced the risk of cardiovascular death or heart failure hospitalization and slowed the decline in kidney function in patients with heart failure, including those with impaired renal function 4.
- A post hoc analysis of the EMPA-REG OUTCOME trial found that empagliflozin reduced the risk of kidney outcomes in patients with type 2 diabetes, including those with heart failure 5.
- The EMPA-KIDNEY trial found that empagliflozin reduced the risk of progression of kidney disease or death from cardiovascular causes in patients with chronic kidney disease, including those with an eGFR as low as 20 ml/min/1.73 m2 6.
Safety and Efficacy in Patients with Impaired Renal Function
- Empagliflozin was found to be well tolerated in patients with impaired renal function, including those with chronic kidney disease 3, 4, 6.
- The risk of kidney-related adverse events was found to be similar between empagliflozin and placebo in patients with impaired renal function 5, 6.
- Empagliflozin was found to slow the decline in kidney function and reduce the risk of kidney outcomes in patients with impaired renal function, including those with chronic kidney disease 3, 4, 5, 6.
Use in Patients Requiring Dialysis
- While there is limited direct evidence on the use of empagliflozin in patients requiring dialysis, the available studies suggest that empagliflozin may be beneficial in patients with impaired renal function, including those with advanced chronic kidney disease 3, 4, 6.
- However, the use of empagliflozin in patients requiring dialysis should be carefully considered, taking into account the individual patient's clinical characteristics and medical history 7.