EMPEROR-Preserved: effect of empagliflozin on cardiovascular death and heart failure hospitalisations in patients with heart failure with a preserved ejection fraction, with and without diabetes

Presented at the ESC congress 2021 by: Prof. Stefan Anker, MD, PhD - Berlin, Germany

Introduction and methods

The EMPEROR-Preserved trial aimed to evaluate the efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo, on top of standard of care, in patients with chronic HF and LVEF >40%, with and without T2DM.

EMPEROR-Preserved randomized a total of 5988 patients (aged ≥18 years, NYHA class II-IV, elevated NT-proBNP, eGFR ≥20, T2DM and non-T2DM) from 622 centers in 23 countries to receive either empagliflozin 10 mg once daily + standard of care (n=2997), or placebo + standard of care (n=2991). The average age of included patients was 72 years, average LVEF was 54%, 45% were women and 49% had T2DM. The primary composite endpoint was time to first event of adjudicated CV death or adjudicated HF hospitalization. Secondary endpoints were total (first and recurrent) adjudicated HF hospitalizations, and slope of change in eGFR from baseline. Median follow-up was 26 months.

Main results

• Empagliflozin significantly reduced the risk of the primary composite endpoint of CV death or HF hospitalization by 21%, compared to placebo (HR 0.79, 95%CI 0.69-0.90, P=0.0003). This effect was primarily driven by a risk reduction in HF hospitalization in the empagliflozin group. The number needed to treat to prevent one primary outcome event during the median study period of 26 months was 31 (95%CI 20-69).
• The effects of this treatment on the primary endpoint were consistent across all pre-specified subgroups, including patients with and without T2DM and patients with LVEF >40 to<50%, ≥50 to <60%, and ≥60%.
• Empagliflozin significantly reduced the first secondary endpoint of first and recurrent HF hospitalizations by 27% (P=0.0009).
• The second secondary endpoint of slope of decline in eGFR from baseline was also significantly reduced by empagliflozin (difference: 1.36 mL/min/1.73m² per year, P<0.0001).

Conclusion

The SGLT2 inhibitor empagliflozin significantly reduced the primary composite endpoint of CV death or HF hospitalization by 21% in patients with HF and EF >40%, with and without diabetes. The effects of this treatment on the primary endpoint were consistent across all pre-specified subgroups, including LVEF and sex. Total (first and recurrent) HF hospitalizations were significantly reduced by 27% by empagliflozin. In addition, the rate of decline in eGFR was slower in patients in the empagliflozin group compared to patients in the placebo group.

-Our reporting is based on the information provided at the ESC Congress-

Watch a video about EMPEROR-Preserved The results of EMPEROR-Preserved were simultaneously published in N Engl J Med.