The Prescription Characteristics, Efficacy and Safety of Spironolactone in Real-World Patients With Acute Heart Failure Syndrome: A Prospective Nationwide Cohort Study

Abstract

BackgroundRandomized clinical trials of spironolactone showed significant mortality reduction in patients with heart failure with reduced ejection fraction. However, its role in acute heart failure syndrome (AHFS) is largely unknown.AimTo investigate the prescription characteristics, efficacy and safety of spironolactone in real-world patients with AHFS.Methods5,136 AHFS patients who survived to hospital discharge using a nationwide prospective registry in Korea were analyzed. The primary efficacy outcome was 3-year all-cause mortality.ResultsSpironolactone was prescribed in 2,402 (46.8%) at discharge: <25 mg in 890 patients (37.1%), ≥25 mg, and <50 mg in 1,154 patients (48.0%), and ≥50 mg in 358 patients (14.9%). Patients treated with spironolactone had a lower proportion of chronic renal failure and renal replacement therapy during hospitalization and had lower serum creatinine level than those who did not. In overall patients, 3-year mortality was not different in both groups (35.9 vs. 34.5%, P = 0.279). The incidence of renal injury and hyperkalemia was 2.2% and 4.3%, respectively, at the first follow-up visit. The treatment effect of spironolactone on mortality was different across subpopulations according to LVEF. The use of spironolactone was associated with a significant reduction in 3-year morality in patients with LVEF ≤ 26% (33.8 vs. 44.3%, P < 0.001; adjusted HR 0.79, 95% CI 0.64–0.97, P = 0.023), but not in patients with LVEF > 26%.ConclusionsAlthough spironolactone was frequently used at lower doses in real-world practice, use of spironolactone significantly reduced 3-year mortality in patients with severely reduced LVEF with acceptable safety profile. However, our findings remain prone to various biases and further prospective randomized controlled studies are needed to confirm these findings.

Korean Society of Heart Failure Guidelines for the Management of Heart Failure: Treatment

“…Aldosterone antagonists or MRA reduce mortality and readmission and improve HF symptoms in patients with HFrEF. 31 32 33) Spironolactone is initiated at a dose of 12.5–25 mg/day and eplerenone at 25 mg/day; both drugs can be increased to 50 mg/day. Since hyperkalemia may occur as a side effect of aldosterone antagonists, a blood test should be performed before initiating the medication to check for abnormalities in kidney function and electrolyte balance, and if the estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73m 2 or serum potassium concentration is >5.0 mEq/L, subsequent drug administration should be cautious.…”

Korean Society of Heart Failure Guidelines for the Management of Heart Failure: Treatment

“…Aldosterone antagonists or MRA reduce mortality and readmission and improve HF symptoms in patients with HFrEF. 31) 32) 33) Spironolactone is initiated at a dose of 12.5–25 mg/day and eplerenone at 25 mg/day; both drugs can be increased to 50 mg/day. Since hyperkalemia may occur as a side effect of aldosterone antagonists, a blood test should be performed before initiating the medication to check for abnormalities in kidney function and electrolyte balance, and if the estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73 m 2 or serum potassium concentration is >5.0 mEq/L, subsequent drug administration should be cautious.…”