Highlights of ESC Congress 2021: Emperor Preserved HF

Results from the EMPEROR-­Preserved trial were presented by Professor Stefan from Berlin in a Hot Line session on 27th August. This international double-blind trial enrolled 5,988 symptomatic HFpEF patients (LVEF >40%) with and without T2DM who had elevated N-terminal pro-BNP concentrations (>300 pg/mL in patients without and >900 pg/mL in patients with atrial fibrillation) along with evidence of structural changes in the heart or documented history of HF hospitalization. Participants were randomized 1:1 to receive empagliflozin 10 mg daily or placebo The primary endpoint was a composite of CV death or hospitalization for HF. The first secondary outcome was HF hospitalizations, including first and recurrent events, while the second secondary outcome assessed the rate of decline in the estimated glomerular filtration rate (eGFR) during study treatment. The average age of participants was 72 years, 45% were women and the average LVEF was 54% During a median follow-up of 26 months, a primary outcome event occurred in 13.8 % of patients in the empagliflozin group and in 17.1% patients in the placebo group the hazard ratio [HR] 0.79 indicating a significant RR of 21%; The effects on the primary outcome were observed across all prespecified subgroups, including patients with or without T2DM and those with LVEF <50%, 50 to <60%, or >=60%. The secondary outcomes, the total number of HF hospitalizations was lower with empagliflozin than with placebo (HR 0.73; indicating significant RR of 27 %. Furthermore, the rate of eGFR decline was slower with empagliflozin than placebo Regarding safety, serious adverse events occurred in 47.9% of patients in the empagliflozin group and 51.6% in the placebo group. Adverse events leading to discontinuation of treatment occurred in 19.1% of patients in the empagliflozin group and 18.4% in the placebo group. Uncomplicated genital and urinary tract infections and hypotension were more common in patients treated with empagliflozin. Empagliflozin convincingly reduced the combined risk of CV death or hospitalization for HF in patients with HFpEF with and without T2DM. EMPEROR-Pooled analysis, which pooled individual patient data from EMPEROR-Reduced and EMPEROR-­Preserved found that in 9,718 patients included in the analysis, empagliflozin reduced the risk of HF hospitalization to a similar degree (about 30% risk reduction) in EMPEROR-Preserved and in EMPEROR-Reduced. The magnitude of the effect on HF hospitalizations was similar across a broad range of ejection fractions lower than 65%, with attenuation of the drug effect at higher ejection fractions (≥65%). The analysis also found that empagliflozin reduced the risk of major renal outcomes in EMPEROR-Reduced, but not in EMPEROR-Preserved Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.