What is the recommended Glomerular Filtration Rate (GFR) cutoff for initiating or continuing Jardiance (empagliflozin) in patients with Impaired renal function?

From the Guidelines

Empagliflozin (Jardiance) should not be initiated in patients with an eGFR below 45 mL/min/1.73m², and for patients already on the medication, it should be discontinued if the eGFR persistently falls below 45 mL/min/1.73m². The medication's effectiveness in glycemic control is reduced as eGFR declines, but its kidney and cardiovascular benefits are preserved 1.

Key Considerations

• The Glomerular Filtration Rate (GFR) cutoff for initiating or continuing Jardiance (empagliflozin) in patients with impaired renal function is based on the medication's pharmacokinetics and the risk of adverse effects.
• According to the most recent evidence, empagliflozin can be used in patients with an eGFR of 45 mL/min/1.73m² or higher, but its use is not recommended in patients with an eGFR below 45 mL/min/1.73m² 1.
• Regular monitoring of renal function is essential when using empagliflozin, particularly in patients with risk factors for kidney disease or those taking medications that affect kidney function.

Clinical Implications

• Empagliflozin works by inhibiting sodium-glucose cotransporter-2 (SGLT2) in the proximal tubule of the kidney, preventing glucose reabsorption and promoting its excretion in urine.
• As kidney function declines, the medication becomes less effective since there is reduced filtration of glucose into the tubules.
• Patients with severely impaired renal function are at higher risk for adverse effects like volume depletion and acute kidney injury.

Recommendations

• Empagliflozin should be used with caution in patients with impaired renal function, and its use should be individualized based on the patient's kidney function and overall clinical status.
• The medication should be discontinued if the eGFR persistently falls below 45 mL/min/1.73m², and alternative treatments should be considered.
• Regular monitoring of renal function and adjustment of the treatment plan as needed are crucial to minimize the risk of adverse effects and optimize the benefits of empagliflozin therapy 1.

From the FDA Drug Label

JARDIANCE should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1. 73 m2. JARDIANCE should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2 Use of JARDIANCE is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2 and is contraindicated in patients with an eGFR less than 30 mL/min/1. 73 m2

The recommended Glomerular Filtration Rate (GFR) cutoff for initiating or continuing Jardiance (empagliflozin) in patients with impaired renal function is:

• Do not initiate Jardiance if eGFR is less than 45 mL/min/1.73 m2
• Discontinue Jardiance if eGFR is persistently less than 45 mL/min/1.73 m2
• Jardiance is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 2, 2, 2

From the Research

Jardiance GFR Cutoff

• The recommended Glomerular Filtration Rate (GFR) cutoff for initiating or continuing Jardiance (empagliflozin) in patients with impaired renal function is not explicitly stated in the provided studies.
• However, a study on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin in subjects with renal impairment found that a single 50 mg dose of empagliflozin was well tolerated in subjects with normal renal function and any degree of renal impairment 3.
• The study suggests that no dose adjustment of empagliflozin is required in patients with renal impairment, but it does not provide a specific GFR cutoff for initiation or continuation of the treatment.

Renal Impairment and Empagliflozin

• A study comparing the effectiveness of empagliflozin and dapagliflozin for kidney outcomes in type 2 diabetes found that the risks of kidney outcomes were comparable between the two treatments, but it does not provide information on the GFR cutoff for initiation or continuation of empagliflozin 4.
• Another study characterizing the initial estimated glomerular filtration rate 'dip' upon sodium-glucose cotransporter-2 inhibition with empagliflozin found that an initial 'eGFR dip' was observed in 28.3% of empagliflozin-treated participants, but it does not provide a specific GFR cutoff for initiation or continuation of the treatment 5.
• A review of empagliflozin for the treatment of type 2 diabetes mentions that empagliflozin is generally well tolerated and effective in patients with renal impairment, but it does not provide a specific GFR cutoff for initiation or continuation of the treatment 6.

Key Findings

• Empagliflozin is well tolerated in patients with renal impairment, and no dose adjustment is required in patients with renal impairment 3.
• The risks of kidney outcomes are comparable between empagliflozin and dapagliflozin 4.
• An initial 'eGFR dip' is observed in some patients treated with empagliflozin, but it does not have a major impact on the treatment effect of empagliflozin on subsequent cardiovascular death, hospitalization for heart failure, and incident or worsening kidney disease 5.