Empagliflozin in patients with heart failure and reduced ejection fraction

Author(s): Naveen Jamwal, S. S. Tripathi, Malvika Misra

Background: Sodium–Glucose Cotransporter 2 (SGLT2) inhibitors reduce the risk of a first hospitalization for heart failure in type 2 diabetics. But data regarding role of SGLT2 inhibitors in HFrEF is limited.

Methods: In this prospective small centre trial, we randomly assigned 822 patients in class II, III, NYHA and an ejection fraction of 35% or less to receive either empagliflozin or placebo, in addition to optimal medical therapy. The primary outcome was a composite of worsening heart failure or cardiovascular death.

Results: Over a period of 24months, the primary outcome occurred in 61 of 411 patients (14.8%) in the empagliflozin group and in 94 of 411 patients (22.9%) in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.87; P 0.003). Of the patients receiving empagliflozin, 40 (9.7%) were hospitalized for heart failure, as compared with 60 patients (14.6%) receiving placebo (hazard ratio, 0.67; 95% CI, 0.46 to 0.97). Cardiovascular deaths occurred in 19 patients (4.6%) who received empagliflozin and in 26 (6.3%) who received placebo(hazardratio, 0.73; 95% CI, 0.41 to 1.30). A total of 36 patients (8.75%) in the empagliflozin group and 49 patients (11.9%) in the placebo group died from any cause (hazardratio, 0.97; 95% CI, 0.97 to 1.30).

Conclusion: In patients with heart failure and a reduced ejection fraction, the risk of cardiovascular death and heart failure is lower among those who received empagliflozin compared to placebo, irrespective of their diabetic status.