From the Guidelines
Jardiance (Empagliflozin) should not be initiated in patients with an estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m², and for patients already taking Jardiance, the medication can be continued until eGFR falls persistently below 45 mL/min/1.73m², at which point it should be discontinued or used with caution, as stated in the study by Galindo et al 1 and further supported by the consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) 1.
Key Considerations
- The glucose-lowering efficacy of Jardiance is reduced as eGFR declines, but kidney and cardiovascular benefits are preserved, as noted in the study by Galindo et al 1.
- The medication works by inhibiting sodium-glucose cotransporter-2 (SGLT2) in the proximal tubule of the kidney, which requires adequate kidney function to be effective, as explained in the study by Galindo et al 1.
- Regular monitoring of kidney function is essential when using Jardiance, particularly in patients with compromised renal function or risk factors for kidney disease, as emphasized in the consensus report by the ADA and KDIGO 1.
Dosing Recommendations
- For patients with eGFR ≥ 45 mL/min/1.73m², no dose adjustment is required, as stated in the study by Galindo et al 1.
- For patients with eGFR < 45 mL/min/1.73m², the medication should be used with caution or discontinued, as recommended in the consensus report by the ADA and KDIGO 1.
Clinical Implications
- Patients with eGFR between 30-45 mL/min/1.73m² may have reduced glycemic efficacy but can still benefit from the cardiovascular and renal protective effects of the medication, as noted in the study by Galindo et al 1.
- As kidney function declines, the glucose-lowering effect of Jardiance diminishes, but cardiovascular and renal benefits may persist at lower eGFR levels, as supported by the consensus report by the ADA and KDIGO 1.
From the FDA Drug Label
The efficacy and safety of JARDIANCE for glycemic control were evaluated in a study of adult patients with type 2 diabetes mellitus with mild and moderate renal impairment (eGFR 30 to less than 90 mL/min/1. 73 m2) Use of JARDIANCE for glycemic control in patients without established cardiovascular disease or cardiovascular risk factors is not recommended when eGFR is less than 30 mL/min/1.73 m2. Studies of adult patients with heart failure enrolled patients with eGFR equal to or above 20 mL/min/1. 73 m2. There are insufficient data to support a dosing recommendation in patients with eGFR below 20 mL/min/1.73 m2. JARDIANCE is contraindicated in patients on dialysis
The glomerular filtration rate (GFR) cut off for Jardiance (Empagliflozin) is:
- less than 30 mL/min/1.73 m2 for patients without established cardiovascular disease or cardiovascular risk factors for glycemic control
- equal to or above 20 mL/min/1.73 m2 for patients with heart failure
- contraindicated in patients on dialysis 2
From the Research
Glomerular Filtration Rate (GFR) Cut Off for Jardiance (Empagliflozin)
- The GFR cut off for Jardiance (Empagliflozin) is an estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2 3, 4
- Empagliflozin has been shown to be effective in patients with type 2 diabetes and an eGFR of ≥30 mL/min/1.73 m2, but with a higher risk of adverse events 5, 6
- The efficacy and safety of empagliflozin have been compared to other antihyperglycemics, including glimepiride, and have been shown to be non-inferior and even superior in some cases 7
- The use of empagliflozin has been associated with a reduced risk of major adverse kidney events (MAKE) and a slower decline in eGFR compared to other antihyperglycemics 5, 6
Key Findings
- Empagliflozin can be used in patients with an eGFR of ≥45 mL/min/1.73 m2 3, 4
- The risk of adverse events increases with declining renal function, and empagliflozin should be used with caution in patients with an eGFR <45 mL/min/1.73 m2 3, 5, 6
- Empagliflozin has been shown to be effective and well-tolerated as a second-line treatment option for patients with type 2 diabetes who have not achieved good glycaemic control on metformin 7
Renal Function and Empagliflozin
- Empagliflozin has been associated with a reduced risk of renal adverse events and a slower decline in eGFR compared to other antihyperglycemics 5, 6
- The use of empagliflozin has been shown to be effective in patients with type 2 diabetes and an eGFR of ≥30 mL/min/1.73 m2, but with a higher risk of adverse events 5, 6