JACC. Heart failure · 2026
Serum Magnesium, Outcomes, and the Effect of Empagliflozin in Heart Failure With Mildly Reduced and Preserved Ejection Fraction: Findings From EMPEROR-Preserved.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Ferreira João Pedro, Packer Milton, Butler Javed, Vasques-Nóvoa Francisco, Marques Pedro, Pocock Stuart, Filippatos Gerasimos, Zannad Faiez, Anker Stefan D
Аннотация
BACKGROUND: Magnesium plays a central role in maintaining cellular homeostasis. Limited data exist on the clinical implications of magnesium derangements and the influence of sodium-glucose cotransporter 2 inhibitors on magnesium levels in heart failure with mildly reduced or preserved ejection fraction.
OBJECTIVES: Using the EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction) population, the authors aimed to study the association of serum magnesium with outcomes, assess the impact of empagliflozin on serum magnesium levels, and explore the influence of serum magnesium on the effect of empagliflozin on the study outcomes.
METHODS: Patients with heart failure with mildly reduced or preserved ejection fraction were randomized to receive placebo or empagliflozin 10 mg daily. Laboratory results were available at baseline; week 4; weeks 12, 32, and 52; and every 24 weeks thereafter. The median follow-up time was 26.2 months. The primary outcome was a composite of cardiovascular death or heart failure hospitalization.
RESULTS: A total of 5,988 patients were included. The mean serum magnesium levels at baseline were 0.82 ± 0.11 mmol/L. The corresponding magnesium quintiles were as follows: Q1 = 0.67 ± 0.07 mmol/L (n = 1,291), Q2 = 0.78 ± 0.02 (n = 1,189), Q3 = 0.83 ± 0.01 (n = 1,378), Q4 = 0.88 ± 0.01 (n = 1,078), and Q5 = 0.96 ± 0.05 (n = 1,052). Patients with higher magnesium levels were older, had lower estimated glomerular filtration rate, and higher prevalence of atrial fibrillation. Conversely, patients with lower serum magnesium had diabetes and used thiazide-type diuretic agents more frequently. Placebo-treated patients experienced a higher risk of primary outcome events with higher magnesium levels (Q5). Empagliflozin (vs placebo) was associated with a more pronounced reduction of primary outcome events at higher baseline magnesium levels: Q1, HR: 1.05 [95% CI: 0.77-1.39]; Q2, HR: 0.85 [95% CI: 0.63-1.14]; Q3, HR: 0.88 [95% CI: 0.66-1.17]; Q4, HR: 0.62 [95% CI: 0.45-0.86]; Q5, HR: 0.60 [95% CI: 0.45-0.79]; interaction P-trend = 0.030. At week 4, empagliflozin had increased magnesium levels by 0.05 mmol/L, reaching a steady state thereafter.
CONCLUSIONS: In EMPEROR-Preserved, higher serum magnesium levels were associated with a higher risk of primary outcome events among patients treated with placebo but not among patients treated with empagliflozin who experienced pronounced benefit. (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction [EMPEROR-Preserved]; NCT03057951).
OBJECTIVES: Using the EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction) population, the authors aimed to study the association of serum magnesium with outcomes, assess the impact of empagliflozin on serum magnesium levels, and explore the influence of serum magnesium on the effect of empagliflozin on the study outcomes.
METHODS: Patients with heart failure with mildly reduced or preserved ejection fraction were randomized to receive placebo or empagliflozin 10 mg daily. Laboratory results were available at baseline; week 4; weeks 12, 32, and 52; and every 24 weeks thereafter. The median follow-up time was 26.2 months. The primary outcome was a composite of cardiovascular death or heart failure hospitalization.
RESULTS: A total of 5,988 patients were included. The mean serum magnesium levels at baseline were 0.82 ± 0.11 mmol/L. The corresponding magnesium quintiles were as follows: Q1 = 0.67 ± 0.07 mmol/L (n = 1,291), Q2 = 0.78 ± 0.02 (n = 1,189), Q3 = 0.83 ± 0.01 (n = 1,378), Q4 = 0.88 ± 0.01 (n = 1,078), and Q5 = 0.96 ± 0.05 (n = 1,052). Patients with higher magnesium levels were older, had lower estimated glomerular filtration rate, and higher prevalence of atrial fibrillation. Conversely, patients with lower serum magnesium had diabetes and used thiazide-type diuretic agents more frequently. Placebo-treated patients experienced a higher risk of primary outcome events with higher magnesium levels (Q5). Empagliflozin (vs placebo) was associated with a more pronounced reduction of primary outcome events at higher baseline magnesium levels: Q1, HR: 1.05 [95% CI: 0.77-1.39]; Q2, HR: 0.85 [95% CI: 0.63-1.14]; Q3, HR: 0.88 [95% CI: 0.66-1.17]; Q4, HR: 0.62 [95% CI: 0.45-0.86]; Q5, HR: 0.60 [95% CI: 0.45-0.79]; interaction P-trend = 0.030. At week 4, empagliflozin had increased magnesium levels by 0.05 mmol/L, reaching a steady state thereafter.
CONCLUSIONS: In EMPEROR-Preserved, higher serum magnesium levels were associated with a higher risk of primary outcome events among patients treated with placebo but not among patients treated with empagliflozin who experienced pronounced benefit. (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction [EMPEROR-Preserved]; NCT03057951).