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

Soo Jin Na, Jong Chan Youn, Hye Sun Lee, Soyoung Jeon, Hae Young Lee, Hyun Jai Cho, Jin Oh Choi, Eun Seok Jeon, Sang Eun Lee, Min Seok Kim, Jae Joong Kim, Kyung Kuk Hwang, Myeong Chan Cho, Shung Chull Chae, Seok Min Kang, Dong Ju Choi, Byung Su Yoo, Kye Hun Kim, Byung Hee Oh, Sang Hong Baek

Research output: Contribution to journalArticlepeer-review


Background: Randomized 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. Aim: To investigate the prescription characteristics, efficacy and safety of spironolactone in real-world patients with AHFS. Methods: 5,136 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. Results: Spironolactone 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%. Conclusions: Although 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.

Original languageEnglish
Article number791446
JournalFrontiers in Cardiovascular Medicine
Publication statusPublished - 2022 Feb 22

Bibliographical note

Funding Information:
This research was supported by the National Research Foundation of Korea (NRF) grant funded by the Ministry of Science and ICT (NRF-2021R1F1A1063430), by the Catholic Medical Center Research Foundation (2021) and by Research of Korea Centers for Disease Control and Prevention (2010-E63003-00, 2011-E63002-00, 2012-E63005-00, 2013-E63003-00, 2014-E63003-01, 2015-E63003-02, 2016-ER6303-00, and 2017-ER6303-01). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Publisher Copyright:
Copyright © 2022 Na, Youn, Lee, Jeon, Lee, Cho, Choi, Jeon, Lee, Kim, Kim, Hwang, Cho, Chae, Kang, Choi, Yoo, Kim, Oh and Baek.

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine


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