From the Guidelines
Jardiance (Empagliflozin) is safe in Acute Kidney Injury (AKI).
Key Considerations
- The use of SGLT2 inhibitors, such as Empagliflozin, has been found to be safe in patients with AKI, with no increased risk of promoting AKI through volume depletion 1.
- In fact, SGLT2 inhibitors have been observed to have consistent efficacy and safety across studied ranges of eGFR, and may even protect patients from AKI 2.
- It is reasonable to continue Empagliflozin therapy if the eGFR falls below the initiation thresholds unless the patient is not tolerating treatment or kidney replacement therapy (KRT) is initiated 2.
Monitoring and Risk Mitigation Strategies
- Monitor for hypovolemia and consider proactive dose reduction of diuretics in patients at high risk 2.
- Hold Empagliflozin during illness, and maintain at least low-dose insulin in insulin-requiring individuals to mitigate the risk of diabetic ketoacidosis 2.
- Educate patients on genital hygiene to reduce the risk of genital mycotic infections, a known complication of SGLT2 inhibitors 2.
Clinical Evidence
- Randomized clinical outcome trials of advanced kidney disease and high cardiovascular disease risk with normal kidney function have not found SGLT2 inhibitors to increase the risk of AKI 1, 3.
- The EMPA-KIDNEY trial, which included patients with eGFR ≥20 ml/min/1.73 m2, was stopped early for clear positive efficacy, further supporting the safety and efficacy of Empagliflozin in patients with CKD 2.
From the FDA Drug Label
JARDIANCE can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine [see Adverse Reactions (6. 1)]. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors, including JARDIANCE.
Jardiance (Empagliflozin) is not safe in Acute Kidney Injury. The drug label reports post-marketing cases of acute kidney injury in patients taking JARDIANCE, and it may cause intravascular volume depletion, which can manifest as symptomatic hypotension or acute transient changes in creatinine 4.
From the Research
Safety of Jardiance (Empagliflozin) in Acute Kidney Injury
- The safety of empagliflozin in patients with acute kidney injury (AKI) has been evaluated in several studies 5, 6, 7, 8, 9.
- A study published in the European journal of heart failure found that empagliflozin caused an initial decline in estimated glomerular filtration rate (eGFR) in patients hospitalized for acute heart failure, but this decline was no longer evident after 90 days 5.
- Another study published in Circulation found that early addition of empagliflozin to standard diuretic therapy increased urine output without affecting renal function in patients with acute decompensated heart failure 6.
- The EMPEROR-Preserved trial found that empagliflozin had a beneficial effect on cardiovascular and kidney outcomes across the spectrum of kidney function, including patients with chronic kidney disease (CKD) and those without CKD 7.
- A study published in Scientific reports found that empagliflozin protected against renal ischemia/reperfusion injury in mice by reducing serum levels of creatinine and urea, attenuating tubular damage, and inhibiting apoptosis in injured kidneys 8.
- A prospective, placebo-controlled, double-blind study published in ESC heart failure found that empagliflozin reduced markers of acute kidney injury in patients with acute decompensated heart failure, including urinary TIMP-2 and IGFBP7 9.
Key Findings
- Empagliflozin may cause an initial decline in eGFR, but this decline is often temporary and not associated with long-term kidney damage 5, 6.
- Empagliflozin may increase urine output and reduce markers of acute kidney injury in patients with acute decompensated heart failure 6, 9.
- The benefits of empagliflozin on cardiovascular and kidney outcomes are consistent across the spectrum of kidney function, including patients with CKD and those without CKD 7.
- Empagliflozin may have renoprotective effects in patients with AKI, including reducing serum levels of creatinine and urea, attenuating tubular damage, and inhibiting apoptosis in injured kidneys 8.