The SGLT2 inhibitor empagliflozin was previously approved for the treatment of symptomatic chronic heart failure only in patients with reduced ejection fraction, but has now also been approved by the MHRA for patients with preserved ejection fraction.
Further informationView empagliflozin drug record
Professor Simon Williams, Past Chair of The British Society for Heart Failure, said: 'Until now there were no approved treatments that can improve outcomes or reduce the likelihood of heart failure hospitalisations for patients across the full spectrum of heart failure, including HFpEF [heart failure with preserved ejection fraction].
'The expanded approval of empagliflozin by the MHRA marks a turning point in the management of heart failure and has the potential to change clinical practice for the thousands of people in the UK affected by this debilitating and life-limiting condition.'
Approval for empagliflozin's expanded indication was based on results from the randomised, double-blind EMPEROR-Preserved phase III trial in patients with heart failure with preserved ejection fraction, with or without diabetes (n=5988).
Analysis showed that empagliflozin 10mg once daily reduced the risk of cardiovascular death or hospitalisation for heart failure versus placebo when added to standard of care.
Over a median of 26.2 months, the composite primary endpoint of cardiovascular death or hospitalisation for heart failure occurred in 415 patients (13.8%) in the empagliflozin group and 511 patients (17.1%) in the placebo group, representing a 21% relative risk reduction with the SGLT2 inhibitor (hazard ratio 0.79, 95% CI 0.69–0.90; p<0.001).