PBS Expansion for Empagliflozin

Empagliflozin is available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of type 2 diabetes, chronic heart failure, and chronic kidney disease (CKD). From 1 November 2025, the CKD listing expanded to cover patients with an eGFR of 20-90mL/min/1.73m² prior to initiation.

Empagliflozin and dapagliflozin are sodium-glucose co-transporter 2 (SGLT2) inhibitors. While originally approved for the management of type 2 diabetes, studies have demonstrated that these medicines can also slow the progression of CKD regardless of diabetes status.

The primary effect of SGLT2 inhibitors is to inhibit the reabsorption of sodium and glucose in the proximal tubules. This produces glucosuria, natriuresis, and osmotic diuresis. Increased delivery of sodium to the distal tubules activates tubuloglomerular feedback mechanisms that lead to reduced intraglomerular pressure. This has been proposed as their mechanism of preserving renal function and reducing proteinuria, although additional processes may be involved.

A meta-analysis compared the safety and efficacy of SGLT-2 inhibitors, glucagon-like peptide-1 (GLP-1) agonists, and non-steroidal mineralocorticoid receptor antagonists (ns-MRA) in CKD. The authors concluded that all three medication classes are associated with significant reductions in cardiovascular and kidney disease risks in patients with CKD. However, SGLT-2 inhibitors may be the most attractive option when considering efficacy together with safety.

Empagliflozin is generally well tolerated. One of the safety concerns is the risk of ketoacidosis. The risk is minimal and largely limited to patients with diabetes. However, cases have been reported in patients without a diagnosis of diabetes. Clinical situations that may predispose to this event include acute intercurrent illness and surgery. Withholding SGLT2 inhibitors during these periods is recommended to prevent ketoacidosis in patients with diabetes. Evidence to guide perioperative dosing in patients without diabetes is currently lacking. Until further evidence is available, the Council of Australian Therapeutic Advisory Groups (CATAG) advise practitioners to refer to the Periprocedural Diabetic Ketoacidosis  (DKA) with SGLT2 Inhibitor use in People  with Diabetes.