A/Prof David Colquhoun
The TGA has expanded the indication for the SGLT2 inhibitor empagliflozin 10mg to include treatment of symptomatic heart failure independent of left ventricular ejection fraction.
The approval provides a welcome advance for heart failure patients with preserved ejection fraction (HFpEF) who have had relatively few therapeutic options compared to patients with a reduced ejection fraction (HFrEF).
The approval is largely based on the results of the EMPEROR-Preserved study which was published last year in the NEJM [link here] and reported in the limbic [link here].
The RCT of almost 6,000 patients with HFpEF found empagliflozin (Jardiance, Boehringer Ingelheim) reduced the combined risk of cardiovascular death or hospitalisation for heart failure by 21%.
The benefit was consistent across pre-specified ejection fraction subgroups (<50%, 50-<60%, and ≥60%) and in patients with or without diabetes.
An editorial in the NEJM [link here] described the results as a “major win against a medical condition that had previously proved formidable” and that it should lead to a change in clinical practice.
Associate Professor David Colquhoun, from the Wesley Hospital in Brisbane, said it was “a long-awaited and major turning point in the management of HFpEF, arguably one of the areas of greatest unmet needs in cardiology.”
He told the limbic that HFpEF patients were typically frail older people with multiple comorbidities. For example, in the EMPEROR-Preserved study cohort, 90% had high blood pressure, 50% had diabetes, 50% had atrial fibrillation.
He said until recently “the cupboard was bare for proven therapies” in HFpEF.
“Exercise helps a little bit to keep fitness up but it doesn’t improve survival in this group of people,” he said.
Associate Professor Colquhoun, Co-chair of the Clinical and Preventative Cardiology Council of the CSANZ, said the TGA approval was a great step forward.
“I would be hopeful that it will be approved for PBS the next time they sit, which is the next couple of months. I don’t think it’d be much longer than that and I can’t see there being much objection about cost considering they are funding it anyway,” he said.
Meanwhile, a Queensland study has found SGLT2 inhibitors are underused in patients with HFrEF and type 2 diabetes.
The study, published in the Internal Medicine Journal [link here], found 54% of the cohort of 666 patients had contraindications to SGLT2 inhibitors such as eGFR >45 mL/min/1.73m2 however only 46% of eligible patients were on SGLT2 inhibitors in 2021.
The study also found patients on SGLT-2 inhibitors had fewer HF hospitalisations than those not on SGLT-2 inhibitors (P = 0.01) consistent with their expected benefits.
A 2022 Australian consensus update on the management of heart failure [link here] includes a strong recommendation for SGLT2 inhibitors in all heart failure patients.