The SGLT2 inhibitors are commonly used in the treatment of type 2 diabetes, but other positive effects associated with their use have been highlighted, such as reduction in body weight, blood pressure and cardiovascular events. Furthermore, these drugs appear to exert protective effects on liver and kidney.
Several studies showed that in patients with type 2 diabetes, SGLT2 inhibitors reduce the risk of hospitalization for heart failure and severe renal adverse events.
Recently, the EMPEROR-Reduced study showed that empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and reduced ejection fraction.
The study was presented at the Congress 2020 of the European Society of Cardiology and published in the New England Journal of Medicine.
The EMPEROR-Reduced study was designed to evaluate the effects of empagliflozin in patients with heart failure and reduced ejection fraction, with or without diabetes, receiving all appropriate treatments for heart failure.
The primary endpoint was a composite of cardiovascular death or hospitalization for heart failure. Secondary endpoints included adverse renal outcomes, defined as chronic dialysis or renal transplantation or sustained reduction in estimated glomerular filtration rate.
By adjusting eligibility based on natriuretic peptide levels, in relation to baseline ejection fraction, the study preferentially enrolled higher risk patients, who had not been well represented in previous studies.
Patients were randomly assigned to take empagliflozin 10 mg once daily or placebo.
The study enrolled 3,730 patients with a mean age of 67 years for patients on active treatment and 66 years for those in the placebo group.
During a median follow-up of 16 months, the primary endpoint occurred in 361 patients in the empagliflozin group and in 462 patients in the placebo group.
Empagliflozin reduced total hospitalizations for heart failure by approximately 30%.
Adverse renal outcomes occurred in 30 patients in the empagliflozin group and in 58 patients in the placebo group.
In contrast, uncomplicated genitourinary tract infections were more common in the empagliflozin group, but the frequency of hypotension, volume depletion, and hypoglycemia were similar in the two groups.
Principal investigator Dr. Milton Packer of the Baylor University Medical Centre, in Dallas, Texas said: “Empagliflozin reduced the risk of serious heart failure events by 30% and decreased the risk of serious adverse renal outcomes by 50%. 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.”
This latest statement by Dr. Packer appears to be well founded. The results obtained from the EMPEROR-Reduced study are so markedly significant that invite to consider the use of empagliflozin in patients with reduced ejection fraction, even in those not affected by diabetes.
The mechanism of action of empagliflozin is probably complex, so much that the authors of the study carefully avoid seeking pathophysiological explanations, venturing into speculative concepts.
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