New data from a sub-analysis of the landmark phase III DAPA-HF ( Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure ) trial have shown that Dapagliflozin ( Farxiga ) has reduced the incidence of the primary composite endpoint of heart failure ( HF ) worsening or cardiovascular ( CV ) death compared to placebo, in patients with heart failure with reduced ejection fraction ( HFrEF ), irrespective of their background therapy ( i.e. other medications for heart failure ).
Dapagliflozin was evaluated in patients who were receiving a broad range of pharmacological treatments, device therapies and cardiac resynchronisation therapy for HFrEF.
A consistent reduction in the primary outcome was observed across all these treatment subgroups.
The results were made available at the American College of Cardiology’s 69th Annual Scientific Session Together with World Congress of Cardiology ( ACC.20/WCC ) and were published in the European Heart Journal.
Dapagliflozin is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with type-2 diabetes ( T2D ).
In the US it is also approved to reduce the risk of hospitalisation for heart failure in patients with T2D and established cardiovascular disease or multiple cardiovascular risk factors.
DAPA-HF is an international, multi-centre, parallel-group, randomised, double-blinded trial in patients with heart failure and reduced ejection fraction ( LVEF less than or equal to 40% ), with and without T2D, designed to evaluate the effect of Dapagliflozin 10mg, compared with placebo, given once daily in addition to standard of care.
The primary composite endpoint was time to the first occurrence of a worsening heart failure event ( hospitalisation or equivalent event; i.e. an urgent heart failure visit ), or cardiovascular death.
Dapagliflozin is a first-in-class, oral once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction.
In the DECLARE CV outcomes trial in adults with T2D, Dapagliflozin has reduced the risk of the composite endpoint of hospitalisation for heart failure or cardiovascular death versus placebo, when both were added to standard of care. ( Xagena )
Source: AstraZeneca, 2020