Dallas, TX—Although sodium–glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce the risk of hospitalization for heart failure in patients, whether or not they also have diabetes, it has been less clear if the benefits persisted in those with significantly reduced ejection fraction.
A study published in the New England Journal of Medicine found that the SGLT2 inhibitor empagliflozin markedly reduced risk of cardiovascular death or hospitalization in patients with severe heart failure. The EMPEROR-Reduced trial also was presented at the virtual European Society of Cardiology conference.
“Empagliflozin reduced the risk of serious heart failure events by 30% and decreased the risk of serious adverse renal outcomes by 50%,” explained principal investigator Milton Packer, MD, of Baylor University Medical Center in Dallas. “This trial extends the benefits of SGLT2 inhibitors to higher-risk patients and shows a meaningful benefit on renal outcomes in patients with heart failure for the first time.”
In fact, according to Dr. Packer, “Based on the combined results of our trial (together with the earlier trial with dapagliflozin), we believe that SGLT2 inhibition with empagliflozin and dapagliflozin will now become a new standard of care for patients with heart failure and a reduced ejection fraction.”
For the double-blind trial, researchers randomly assigned 3,730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin—10 mg once daily—or placebo, in addition to recommended therapy. Denoted as the primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.
Results indicate that, during a median of 16 months, a primary outcome event occurred in 361 of 1,863 patients (19.4%) in the empagliflozin group and in 462 of 1,867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% CI, 0.65-0.86; P <.001).
The authors point out that the effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. They note that the total number of hospitalizations for heart failure was significantly lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58-0.85; P <.001).
In addition, according to researchers, the annual rate of decline in the estimated glomerular filtration rate was slowed down in the empagliflozin group, compared with the placebo group (–0.55 vs. –2.28 mL per minute per 1.73 m2 of body-surface area per year, P <.001), while, overall, empagliflozin-treated patients had a lower risk of serious renal outcomes. An adverse effect, uncomplicated genital-tract infection, was reported more frequently with empagliflozin, however, the study says.
The authors explain how study findings are “consistent with the hypothesis that SGLT2 inhibitors may slow the progression of cardiac and renal disease, regardless of cause and independent of the presence or absence of diabetes.”
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