The full results of the EMPEROR-Preserved study confirm as findings that empagliflozin decreases the risk of death or hospitalization for heart failure (HF) in both patients with reduced and with preserved function.
The primary endpoint (a composite of death and hospitalization for HF) was reduced by 21% on a relative basis with sodium/glucose cotransporter 2 inhibitor or SGLT2 (13.8% vs. 17.1%; hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.69 to 0.90). This difference was mainly driven by the reduction in hospitalizations. To avoid an event, 31 patients need to be treated.
These results, presented at the European Society of Cardiology (ESC) 2021 Congress and simultaneously published in NEJM, are the first in history to show the benefits of a drug on patients with heart failure—both with preserved and reduced ejection fraction.
A positive work on HF with preserved fraction had not been published for at least 15 years.
In other previous studies (EMPEROR-Reduced and DAPA-HF), empagliflozin and other SLGT2 inhibitors had shown a reduction in clinical events in patients with reduced ejection fraction.
However, so far no work had been dedicated to patients with preserved ejection fraction.
EMPEROR-Preserved randomized 5988 patients with functional class II-IV and ejection fraction >40% (mean age 75 years and mean ejection fraction 54%) to 10 mg of empagliflozin QD vs. placebo (with all other optimal medication, in all cases). Almost half of the included patients had a diagnosis of diabetes.
Read also: ESC 2021 | COVERT-MI: Colchicine Attempts to Reduce Infarct Size.
The observed reduction in the primary endpoint was mostly attributed to fewer first and subsequent hospitalizations due to heart failure (407 vs. 541; HR: 0.73; 95% CI: 0.61 to 0.88).
This work also showed a slowing deterioration of renal function compared with the placebo.
The most common adverse events were uncomplicated urinary tract infection and hypotension.
NEJM also published the results of EMPEROR-Reduced (which included patients with HF and reduced ejection fraction).
Overall, the results showed a consistent reduction of events in both EMPEROR studies with a 30-% reduction in hospitalizations in the ejection fraction range between <25% and 65%.
Renal protection was more evident and significant for patients with ejection fraction below 50% (p = 0.02).
EMPEROR-Preserved EmperorOriginal Title: Empagliflozin in heart failure with a preserved ejection fraction. EMPEROR-Preserved Trial Investigators
Reference: Presentado por Anker SD en el ESC 2021 y publicado simultáneamente en NEJM.
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