Expanded PBS Listing for Dapagliflozin

The Pharmaceutical Benefits Scheme (PBS) listing for dapagliflozin has recently been expanded. It is now subsidised for the treatment of heart failure independent of left ventricular ejection fraction (LVEF).

When used for the management of heart failure, dapagliflozin was previously only subsidised for patients with reduced ejection fraction. This was supported by the DAPA-HF trial, which found benefits in patients with an LVEF of <40%. The DELIVER study built on this by investigating the efficacy of dapagliflozin in patients with an LVEF > 40%. Patients were randomly assigned to receive dapagliflozin 10mg daily or placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure or cardiovascular death. With a median follow-up of 2.3 years, the primary outcome occurred in 16.4% of the dapagliflozin group and 19.5% of the placebo group (hazard ratio: 0.82, 95% CI: 0.73-0.92, P<0.001).

Common adverse effects include genital infections (such as vulvovaginal candidiasis and balanitis), polyuria, dysuria, urinary tract infection, and dyslipidaemia. This class of medications is rarely reported to cause euglycaemic ketoacidosis in patients with diabetes, particularly in association with stressors such as surgery or acute illness. To reduce this risk, the Australian Diabetes Society recommends withholding dapagliflozin for at least three days for most surgical procedures in patients with diabetes. The current evidence suggests that the risk of dapagliflozin causing ketoacidosis in patients without diabetes is unlikely.