The product information for empagliflozin-containing products (Jardiance®, Jardiamet®, and Glyxambi®) have been updated. These products are now contraindicated in patients with severe renal impairment with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 (or a creatinine clearance of less than 30mL/min in the case of Jardiamet®)
Empagliflozin is a sodium-glucose linked transporter-2 (SGLT2) inhibitor used in the treatment of type 2 diabetes. It improves glycaemic control by reducing the renal tubular reabsorption of glucose. However, this effect is dependent upon renal function and reduces in renal impairment.
Studies demonstrate that SGLT2 inhibitors also have cardiorenal benefits that appear to be independent of their glucose-lowering action. The recent EMPEROR-Reduced trial investigated the cardiovascular and renal outcomes of empagliflozin in patients with an eGFR as low as 20 mL/min/1.73 m2. Analysis of this data suggests that empagliflozin retains key cardiorenal benefits regardless of the extent of renal impairment at baseline.
A transient reduction in eGFR may occur upon initiation of an SGLT2 inhibitor, particularly in patients with pre-existing renal impairment or hypovolaemia. Kidney Health Australia advises that SGLT2 inhibitors be withheld during periods of acute illness or dehydration in order to prevent acute kidney injury. Other available SGLT2 inhibitors (i.e. dapagliflozin and ertugliflozin) remain contraindicated in patients with an eGFR persistently <45 mL/min/1.73 m2 when used for glycaemic control.
- Chronic Kidney Disease (CKD) Management in Primary Care (4th edition). Kidney Health Australia: Melbourne; 2020.
- Giorgino F, Vora J, Fenici P, Solini A. Renoprotection with SGLT2 inhibitors in type 2 diabetes over a spectrum of cardiovascular and renal risk. Cardiovasc Diabetol. 2020: 19(1); 196.
- Jardiance® (Empagliflozin) Australian approved product information. North Ryde: Boehringer Ingelheim. Approved May 2021.
- Zannad F, Ferreira JP, Pocock SJ, Zeller C, Anker SD, Butler J, et al. Cardiac and kidney benefits of empagliflozin in heart failure across the spectrum of kidney function: insights from EMPEROR-Reduced. Circulation 2020; 143(4): 310-21.