Second SGLT2 inhibitor approved for heart failure

From 1 April, empagliflozin has been available as adjunct therapy for adults with heart failure with reduced ejection fraction (HFrEF).
 
The sodium-glucose co-transporter-2 (SGLT2) inhibitor, sold as Jardiance, joins dapagliflozin (sold as Forxiga) as the second medicine of this class to be approved for use in heart failure (HF).
 
Patients must be symptomatic with New York Heart Association (NYHA) class II-IV HF and have a documented left ventricular ejection fraction less than or equal to 40%.
 
The treatment must be an add-on therapy to optimal HFrEF treatment.
 
This includes treatment with a beta-blocker, and either an ACE inhibitor, angiotensin II antagonist, or angiotensin receptor with neprilysin inhibitor (ARNI) combination therapy.
 
Previously, empagliflozin was only PBS listed for the treatment of diabetes.
 
The listing follows the results of the EMPEROR-Reduced clinical trial, a phase 3 study which found that patients with HFrEF who were treated with empagliflozin (10 mg once daily) in addition to standard therapy, had a lower risk of cardiovascular death and HF-related hospitalisation (19.4%) than those in the placebo group (24.7%).
 
These results correspond to a number needed to treat (NNT) of 19 to prevent one cardiovascular death or HF-related hospitalisation.
 
Similar outcomes were seen in studies looking at dapagliflozin, including the DAPA-HF clinical trial, which found a lower risk of cardiovascular death and heart-failure-related hospitalisation in the treatment group (16.3%) compared to placebo (21.2%), with a NNT of 21.
 
NPS MedicineWise medical advisor and GP, Dr Caroline West, welcomes the new listing.
 
‘It is very exciting to see we are broadening the treatment options for heart failure as new evidence comes to light,’ she told newsGP.
 
‘The listing of two new medicines for HF in recent months is going to make a significant difference to the health outcomes of those suffering from heart failure.’
 
HF remains a leading cause of death in Australia, with around one in 50 deaths attributed to the condition.
 
Dr West says the cardioprotective effects of SGLT2 inhibitors in HF are not yet fully understood, but they do appear to be independent of glucose-lowering effects.
 
‘We know that in diabetes, SGLT2 inhibitors increase urinary glucose excretion through their action on SGLT2 proteins in the kidney,’ she said.
 
‘There are a number of hypotheses as to how these medicines also confer cardio-protection, and it will be equally exciting to see the results of further research into this area.’
 
For now, eligible patients with HFrEF are recommended to take one 10 mg tablet of empagliflozin daily in addition to optimised standard therapy.
 
Common adverse effects include urinary tract and genital infections.
 
Caution is advised in patients with reduced renal function, acute serious illness or volume depletion, and those also taking loop diuretics.
 
Treatment should be avoided in those with eGFR less than 30 mL/min/1.73 m2, and in patients who are pregnant or breastfeeding.
 
Dr Wests says the treatment of HF is definitely ‘space to watch’ for GPs.
 
‘As the management of HF evolves, we are likely to see more treatment options become available,’ she said.
 
‘I encourage all GPs to keep a watchful eye out for new developments like this one.’
 
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