As Doctor Milton Packer (Baylor University Medical Center, Dallas, TX, USA) described in a Hot Line at ESC Congress 2020 today, the EMPEROR-Reduced trial evaluated the effects of empagliflozin 10 mg once daily vs. placebo in 3,730 patients with HF and a reduced left ventricular ejection fraction (LVEF ≤40%), with or without diabetes, who were already receiving all appropriate treatments for HF. To preferentially enrol higher-risk patients, the protocol required that baseline levels of N‐terminal prohormone B‐type natriuretic peptide (NT‐proBNP) exceeded pre‐defined levels that varied with LVEF, i.e. the closer the LVEF to 40%, the higher the qualifying value for circulating level of NT-proBNP.
During a median follow-up of 16 months, the primary endpoint of cardiovascular death or hospitalisation for HF was significantly reduced in the empagliflozin group vs. the placebo group (361 vs. 462 events; hazard ratio [HR] 0.75; 95% confidence interval [CI] 0.65–0.86; p<0.0001). Empagliflozin reduced the risk of total hospitalisations for HF by 30% (HR 0.70; 95% CI 0.58–0.85; p<0.001). Furthermore, adverse renal outcomes (chronic dialysis or renal transplant or sustained reduction of estimated glomerular filtration rate) were significantly reduced by 50% with empagliflozin vs. placebo (HR 0.50; 95% CI 0.32–0.77; p<0.01).
Regarding safety, uncomplicated genitourinary tract infections were more common in the empagliflozin group (1.3% vs. 0.4%), but the frequency of hypotension, volume depletion and hypoglycaemia were similar in the two groups.
Dr. Packer said, “This trial extends the benefits of SGLT2 inhibitors to higher-risk patients and shows a meaningful benefit on renal outcomes in patients with HF for the first time.” He concluded that SGLT2 inhibition with empagliflozin and dapagliflozin will now become a new standard of care for patients with HF and a reduced ejection fraction.