Expanded PBS Listing for Dapagliflozin

The Pharmaceutical Benefits Scheme (PBS) listing for dapagliflozin has been expanded to include the treatment of chronic kidney disease (CKD).

Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that was previously only available on the PBS for type 2 diabetes and chronic heart failure. Interest in the potential renoprotective effects of this class emerged following positive results in patients with CKD and type 2 diabetes. The DAPA-CKD trial demonstrates that these effects may be independent of the presence of type 2 diabetes.

DAPA-CKD is a large double-blind, placebo-controlled trial investigating the effect of dapagliflozin on patients with CKD. Participants were randomised to receive dapagliflozin 10mg daily or placebo. All participants were required to be stabilised on an ACE inhibitor or angiotensin receptor blocker for at least four weeks prior to screening (unless there was a documented contraindication or intolerance). The primary outcome was a composite of a sustained reduction in eGFR of at least 50%, end-stage renal disease, or death from renal or cardiovascular causes. Over the follow-up period (median of 2.4 years), a primary outcome occurred in 9.2% of the dapagliflozin group compared to 14.5% of the placebo group. These effects were similar in patients with and without diabetes.

The safety profile reported in the trial population was consistent with the known safety profile of dapagliflozin. Common adverse effects include infections of the genital tract and urinary tract, polyuria, dysuria, and constipation.