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.
Highlights
Aldosterone has gained interest as a therapeutic target due to its independent and significant role in the pathophysiology of heart failure (HF)
Because our study aimed to identify whether spironolactone have a homogeneous treatment effect among patient subpopulations with different ejection fraction, we included the whole range of LVEF
The proportion of de novo HF, hypertension, diabetes, and ischemic heart disease were higher in the no spironolactone group, and the proportion of dilated cardiomyopathy, and atrial fibrillation were higher in the spironolactone group
Summary
Aldosterone has gained interest as a therapeutic target due to its independent and significant role in the pathophysiology of heart failure (HF). After the results of the Randomized Aldactone Evaluation Study (RALES) trial, which demonstrated an association between spironolactone and considerable mortality risk reduction in patients with severe HF, mineralocorticoid antagonists became a component of treatment for HF with reduced ejection fraction (HFrEF) [2–4]. Data on the efficacy and safety of spironolactone in patients with acute heart failure syndrome (AHFS) including HFpEF are still limited. Even in the Aldosterone Antagonist Therapy for Adults with Heart Failure and Preserved Systolic Function (TOPCAT) trial, which investigated the use of spironolactone in HFpEF, outcome improvement was identified only in patients enrolled in the Americas, not all participants [6, 7]. Randomized clinical trials of spironolactone showed significant mortality reduction in patients with heart failure with reduced ejection fraction. Its role in acute heart failure syndrome (AHFS) is largely unknown
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