Empagliflozin in the Treatment of Patients with Chronic Heart Failure
Unlike other antidiabetics, sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization due to heart failure and the risk of severe renal events in patients with type 2 diabetes mellitus. The efficacy of the SGLT2 inhibitor empagliflozin directly in the treatment of patients with chronic heart failure with reduced ejection fraction was evaluated in the EMPEROR-Reduced clinical study, the recently published results of which we summarize in the following article.
Protective Effect of SGLT2 Inhibitors
In large randomized clinical trials, SGLT2 inhibitors were observed to reduce the risk of hospitalization for heart failure by 30−35% compared to placebo. The greatest benefit was observed in patients who had a left ventricular ejection fraction (LVEF) ≤ 30% at the start of treatment. Additionally, a 35–50% reduction in the risk of kidney disease progression was observed. The cardio-renal protective effect of SGLT2 inhibitors cannot be explained solely by blood sugar reduction, as similar benefits were not observed with other drugs that reduce glycemia even more aggressively.
Dapagliflozin showed a reduction in the risk of death or hospitalization due to cardiovascular reasons in patients with mild to moderate left ventricular dysfunction and elevated natriuretic peptide levels in the DAPA-HF clinical trial, regardless of the presence of diabetes. The presented EMPEROR-Reduced study evaluated empagliflozin in patients with chronic heart failure with reduced left ventricular ejection fraction. The study included a larger proportion of patients with severe systolic dysfunction of the left ventricle.
Study Methodology and Population
The double-blind, placebo-controlled study involved 3730 patients with NYHA class II−IV heart failure and LVEF ≤ 40%. Half of them had a history of diabetes. In addition to their standard treatment, they received empagliflozin at a dose of 10 mg once daily or placebo. The primary composite endpoint was the occurrence of death from cardiovascular causes or hospitalization due to worsening heart failure.
Results
During the follow-up period (median 16 months), death from cardiovascular causes or hospitalization due to worsening heart failure occurred in 19.4% of patients in the empagliflozin group and 24.7% of patients in the placebo group (hazard ratio [HR] 0.75; 95% confidence interval [CI] 0.65−0.86; p < 0.001). The effect of empagliflozin was maintained regardless of the presence of diabetes.
The annual decline in estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (−0.55 vs. −2.28 ml/min/1.73 m2 body surface area per year; p < 0.001). Patients treated with empagliflozin had a lower risk of severe renal events. Non-complicated genital tract infections were more common in patients on empagliflozin.
Conclusion
The use of empagliflozin was associated with a lower combined risk of death from cardiovascular causes or hospitalization for heart failure compared to placebo. In patients with chronic heart failure with reduced ejection fraction, empagliflozin slowed the gradual progression of worsening kidney function, regardless of the presence of diabetes.
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Source: Packer M., Anker S. D., Butler J. et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med 2020 Oct 8; 383 (15): 1413−1424, doi: 10.1056/NEJMoa2022190.
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