Jardiance is licensed for use in patients with symptomatic chronic heart failure with reduced ejection fraction. The drug is the second SGLT2 inhibitor to be approved for use in heart failure after Forxiga (dapagliflozin), which was recommended by NICE earlier this year as a 'stepchange' in the management of the condition.
The approval of empagliflozin for the new indication is based on the results of the randomised, double-blind EMPEROR-Reduced trial, in which the drug significantly reduced the risk of cardiovascular death or hospitalisation due to heart failure compared with placebo.
A total of 3730 patients with chronic heart failure (NYHA class II, III or IV) and an ejection fraction of 40% or less were randomised to receive empagliflozin 10mg or placebo daily, in addition to standard care. The study population consisted of 76.1% men and 23.9% women with a mean age of 66.8 years; 70.5% were white, 18.0% Asian and 6.9% black/African American.
Over a median of 16 months, cardiovascular death or hospitalisation for heart failure occurred in 19.4% of patients in the empagliflozin group and 24.7% of those in the placebo group, showing that empagliflozin reduced the relative risk of the primary composite endpoint by 25% compared with placebo (hazard ratio 0.75; 95% CI 0.65–0.86; p<0.001).
Subgroup analysis found that the superiority of empagliflozin to placebo in preventing the primary outcome was consistent regardless of the presence or absence of diabetes.
In addition, empagliflozin significantly reduced the rate of eGFR decline compared with placebo (-0.55 vs. -2.28ml/min/1.73m2 per year, p<0.001).
The safety profile of empagliflozin in patients with heart failure was generally consistent with that in patients with diabetes. The most frequent adverse reaction was volume depletion, which was reported in 10.6% of patients treated with the SGLT2 inhibitor and 9.9% of those who received placebo.