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Hot Line: Not just in diabetes – empagliflozin improves outcomes in patients with heart failure in the EMPEROR-Reduced trial

Early embargo lift

Sodium-glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of major adverse cardiovascular events and hospitalisations for heart failure (HF) in patients with type 2 diabetes.1-3 But important questions remained including could SGLT2 inhibitors treat HF in those with an established HF diagnosis? And could these drugs exert favourable effects in patients without diabetes?

Heart Failure

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.



1. Zinman B, et al. N Engl J Med 2015;373:2117–2128.

2. Neal B, et al. N Engl J Med 2017;377:644–657.

3. Wiviott SD, et al. N Engl J Med 2019;380:347–357.

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.