From the Guidelines
Jardiance (empagliflozin) is contraindicated in patients with end-stage renal disease (ESRD). Patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73m² should not use this medication for glycemic control, and it is explicitly contraindicated in ESRD, as stated in the 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes 1. The mechanism of action of Jardiance, which involves inhibiting sodium-glucose cotransporter-2 (SGLT2) in the kidneys, requires adequate kidney function to be effective. In ESRD, the severely reduced kidney function means the drug cannot work properly and may increase the risk of adverse effects without providing therapeutic benefit.
Some key points to consider when managing patients with ESRD and diabetes include:
- The importance of alternative diabetes management strategies, such as insulin therapy or other glucose-lowering medications that do not rely on renal function 1.
- The potential benefits of pancreas transplantation in patients with Type 1 diabetes and ESRD, including improved glycemic control and reduced risk of complications 1.
- The need for careful monitoring of kidney function and adjustment of medication doses or discontinuation of certain medications, such as Jardiance, in patients with declining kidney function.
Overall, the contraindication of Jardiance in ESRD is based on the lack of efficacy and potential increased risk of adverse effects in patients with severely reduced kidney function, and alternative management strategies should be considered in these patients.
From the FDA Drug Label
4 CONTRAINDICATIONS
Severe renal impairment, end-stage renal disease, or dialysis [see Use in Specific Populations (8.6)].
Jardiance is contraindicated in ESRD. The drug label explicitly states that JARDIANCE is contraindicated in patients with severe renal impairment, end-stage renal disease, or dialysis 2.
From the Research
Jardiance Contraindication in ESRD
- Jardiance, also known as empagliflozin, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to treat type 2 diabetes mellitus (T2DM) 3.
- According to the study published in Biomedicines, empagliflozin has a contraindication in patients with a glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 3.
- However, another study published in Clinical pharmacokinetics found that there were no clinically relevant alterations in pharmacokinetics in patients with mild to severe renal impairment and end-stage renal disease (ESRD) 4.
- The EMPRISE study published in the Journal of diabetes research found that empagliflozin was associated with a lower risk of all-cause mortality, hospitalization for heart failure, and end-stage renal disease compared to DPP-4i in Nordic type 2 diabetes patients 5.
Key Considerations
- Empagliflozin may be used in patients with ESRD, but with caution and close monitoring of renal function 4.
- The benefits of empagliflozin in reducing the risk of cardiovascular events and mortality may outweigh the potential risks in patients with ESRD 5.
- However, the decision to use empagliflozin in patients with ESRD should be made on a case-by-case basis, taking into account the individual patient's characteristics and medical history 3, 4, 5.