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In a pooled analysis of 2 key clinical trials, empagliflozin was beneficial in patients with heart failure with a reduced and preserved ejection fraction.
Empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly and Company) was found beneficial in patients with heart failure with a reduced and preserved ejection fraction in a pooled analysis of the EMPEROR-Reduced and EMPEROR-Preserved trials.
The late breaking study was presented in a Hot Line session today at the European Society of Cardiology (ESC) Congress 2021, held virtually between August 27-30, 2021.
Results of the EMPEROR-Reduced trial were published in October 2020 and showed that empagliflozin reduced the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a reduced ejection fraction. Findings from EMPEROR-Preserved, also presented today at ESC Congress 2021, demonstrated that empagliflozin also reduced this composite cardiovascular endpoint in patients with heart failure and a preserved ejection fraction.
The current analysis pooled the results of these 2 trials on an individual patient level, which was possible due to the very similar study designs. The major difference between the studies was the enrollment of patients with heart failure and an ejection fraction of ≤40% in EMPEROR-Reduced and patients with heart failure and an ejection fraction of ≥40% in EMPEROR-Preserved.
"This analysis was prospectively designed and we developed a statistical plan before any patient was recruited in either trial,” said principal investigator Milton Packer, MD, distinguished scholar in Cardiovascular Science, Baylor University Medical Center, Dallas, Texas, in an ESC press release. “The evaluation was alpha-protected, meaning that the endpoints were statistically powerful and unbiased because by specifying the pooled analysis in the individual trials it was protected from an inflated false positive error rate.”
Across the 9718 patients included in the analysis, empagliflozin reduced the risk of hospitalization for heart failure to a similar degree (about 30% risk reduction). The magnitude of this effect was similar across a broad range of ejection fractions below 65%, with attenuation of empagliflozin’s effect at higher ejection fractions (≥65%), according to the press release.
Investigators also found that empagliflozin reduced the risk of major renal outcomes in EMPEROR-Reduced, but not in EMPEROR-Preserved. However, when renal outcomes were defined using more stringent criteria in EMPEROR-Preserved, the influence of pretreatment ejection fraction on the effect of empagliflozin on renal outcomes paralleled empagliflozin’s effect on heart failure hospitalizations.
“Taken together, these findings demonstrate the benefits of empagliflozin across a broad range of patients with heart failure with a reduced and preserved ejection fraction, including many not effectively treated with currently available agents,” said Dr Packer.