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First SGLT2 approved for heart condition

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Dapagliflozin (sold as Forxiga) has been extended to include the treatment of symptomatic heart failure with reduced ejection fraction (systolic heart failure) in adults, as an addition to the current standard of care.
 
The drug is the first sodium-glucose co-transporter-2 (SGLT2) inhibitor to be approved in Australia by the Therapeutic Goods Administration for the treatment of heart failure in patients with reduced ejection fraction.
 
Listed on the PBS from December 2013 as third-line add-on dual-therapy after metformin and a sulfonylurea, the listing restriction changed from December 2014 to allow second-line dual-therapy after metformin or a sulfonylurea.

Brisbane GP and RACGP Education Committee member Dr Anita Sharma welcomed the registration of dapagliflozin to assist GPs in the notable role they have in the management of heart failure.
 
‘Most patients with heart failure present to their GPs first,’ she said.
 
‘They [GPs] are ideally placed to diagnose, initiate, holistically manage and monitor appropriate therapies in the context of their patient’s comorbidities.
 
‘GPs are well aware of SGLT2 inhibitors for type 2 diabetes management. This registration now gives primary carers new options to help patients better manage their heart failure and prevent 
hospitalisations, which are a significant burden both on patients and the health system.’ 
 
An average of 172 Australians are hospitalised due to heart failure every day.
 
Heart failure is a leading cause of death in Australia, accounting for one in 50 deaths. The condition currently affects around 110,000 Australians, over half of whom have a reduced ejection fraction.
 
Dapagliflozin works to protect the heart from getting weaker and improves common symptoms, such as breathlessness, fatigue, tiredness and ankle swelling.
 
According to Heart Foundation CEO Adjunct Professor John Kelly, the new, evidence-based treatment intervention now available will help improve the management of reduced ejection fraction and reduce risk of potential hospital presentations.
 
‘Despite significant advances, health outcomes are poor for people with heart failure and the financial and emotional costs are incredibly high,’ Professor Kelly said.
 
‘More needs to be done to improve health outcomes in heart failure patients, which is why new breakthroughs in effective treatments are so important and needed.’ 

A recent study published in The Lancet of two trials of 8474 patients with heart failure with reduced ejection fraction, found the estimated treatment effect of SGLT2 inhibitors was a 13% reduction in all-cause death and 14% reduction in cardiovascular death.

SGLT2 inhibition was accompanied by a 26% relative reduction in the combined risk of cardiovascular death or first hospitalisation for heart failure, and by a 25% decrease in the composite of recurrent hospitalisations for heart failure or cardiovascular death, the authors found.

The Heart Foundation sets the clinical guidelines for prevention, detection and management of heart failure in Australia, providing evidence-based advice for healthcare providers.
 
While the guidelines still recommend the use of SGLT2 inhibitor in type 2 diabetes patients only, healthcare providers will now be able to use dapagliflozin as an additional support to the standard of care for heart failure, regardless of a patient’s type 2 diabetes status. 
 
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dapagliflozin heart failure reduced ejection fraction SGLT2

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