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Dapagliflozin approved in EU for heart failure across full ejection fraction spectrum

The sodium-glucose co-transporter 2 inhibitor dapagliflozin has received EU approval for use in symptomatic chronic heart failure

Although used for the management of type 2 diabetes, dapagliflozin (brand name Forxiga) has now been approved in the EU for patients with heart failure across the full spectrum of ejection fractions according to a press release by the manufacturer, AstraZeneca.

It has been estimated that globally, 64.3 million people are living with heart failure and chronic heart failure represents a leading cause of hospitalisation among those 65 years and older. Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor, used in the management of type 2 diabetes, but also appears to reduce adverse outcomes in patients with heart failure. In fact, studies have shown how the drug is effective in type 2 diabetics and heart failure, with an ejection fraction of less than 40%. Furthermore, in pursuing the value of the drug in heart failure, more recent data show that dapagliflozin at a dose of 10 mg daily, was able to reduce the combined risk of worsening heart failure and cardiovascular death in patients with either a mildly reduced or preserved ejection fraction.

Dapagliflozin use across heart failure ejection fractions

In a patient-level pooled analysis of the only two trials which tested dapagliflozin in heart failure with ejection fractions either ≤40% or >40%, there was no evidence that the effect of the drug varied by ejection fraction. In fact, the combined analysis revealed how dapagliflozin reduced both the risk of cardiovascular death and hospitalisations for heart failure.

The drug is now approved in the EU for use in type 2 diabetes, chronic heart failure and in adults with chronic kidney disease.

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