Forxiga is indicated to treat symptomatic chronic heart failure in patients with reduced ejection fraction. It is the first SGLT2 inhibitor to be licensed for use in this setting, based on evidence it significantly reduces the risk of cardiovascular death and worsening of heart failure compared with placebo.
John McMurray, Professor of Medical Cardiology at the University of Glasgow, said the drug 'provides physicians with a completely novel treatment for heart failure with reduced ejection fraction, not only improving symptoms and reducing hospital admissions, but also increasing survival in this life-threatening condition.'
The approval of Forxiga is based on the results of the DAPA-HF phase III trial, which enrolled patients with NYHA class II, III, or IV heart failure and an ejection fraction of 40% or less (n=4744).
The trial showed that dapagliflozin 10mg once daily, in addition to standard of care, reduced the risk of the composite outcome of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent visit resulting in intravenous therapy for heart failure) by 26% compared with placebo (hazard ratio 0.74 [95% CI 0.65-0.85]; p < 0.001).
During the trial, one cardiovascular death or hospitalisation for heart failure or an urgent visit associated with heart failure could be avoided for every 21 patients treated with the SGLT2 inhibitor.
The overall safety profile of dapagliflozin in patients with heart failure was consistent with its known safety profile in patients with diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycaemia did not differ between treatment groups.