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Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms
Open accessAbstract
BACKGROUND: Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms. METHODS: In this randomized, double-blind trial, we randomly assigned 2737 patients with New York Heart Association class II heart failure and an ejection fraction of no more than 35% to receive eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. RESULTS: The trial was stopped prematurely, according to prespecified rules, after a median follow-up period of 21 months. The primary outcome occurred in 18.3% of patients in the eplerenone group as compared with 25.9% in the placebo group (hazard ratio, 0.63; 95% confidence interval [CI], 0.54 to 0.74; P<0.001). A total of 12.5% of patients receiving eplerenone and 15.5% of those receiving placebo died (hazard ratio, 0.76; 95% CI, 0.62 to 0.93; P=0.008); 10.8% and 13.5%, respectively, died of cardiovascular causes (hazard ratio, 0.76; 95% CI, 0.61 to 0.94; P=0.01). Hospitalizations for heart failure and for any cause were also reduced with eplerenone. A serum potassium level exceeding 5.5 mmol per liter occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001). CONCLUSIONS: Eplerenone, as compared with placebo, reduced both the risk of death and the risk of hospitalization among patients with systolic heart failure and mild symptoms. (Funded by Pfizer; ClinicalTrials.gov number, NCT00232180.).
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“This effect was independent of diabetes status, and baseline HbA1c did not modify the effects on the primary outcome.531”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [531]
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“The mortality benefit of spironolactone in the RALES trial and eplerenone in the EMPHASIS-HF trial was consistent in T2DM and non-T2DM patients with HFrEF.158,159”
From Type 2 diabetes mellitus and heart failure: A position statement from the Heart Failure Association of the European Society of Cardiology (2018) · cites this paper as [159]
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Imran, M., Hassan, M. Q., Akhtar, M. S., Rahman, S. O., Akhtar, M., & Najmi, A. K. (2018) · Clinical and Experimental Hypertension · doi:10.1080/10641963.2018.1441862 · Cited by 34
“channel blockers (7) and mineralocorticoid receptor antagonists (8) have shown to decrease the mortality among patient of MI with concurrent HF.”
BackgroundMineralocorticoid Receptor Antagonists in Patients With Heart Failure and Impaired Renal Function
Matsumoto, S., Henderson, A. D., Shen, L., Yang, M., Swedberg, K. B., Vaduganathan, M., van Veldhuisen, D. J., Solomon, S. D., Pitt, B., Zannad, F. M., et al. (2024) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2024.03.426 · Cited by 37
Self-citationMineralocorticoid Antagonism in Heart Failure
Chang, J., Ambrosy, A. P., Vardeny, O., Spall, H. G. C. V., Mentz, R. J., & Sauer, A. J. (2024) · JACC Heart Failure · doi:10.1016/j.jchf.2024.08.007 · Cited by 36
Reduction of cardiovascular risk in chronic kidney disease by mineralocorticoid receptor antagonism
Epstein, M. (2015) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(15)00289-2 · Cited by 33
Emerging cardiovascular indications of mineralocorticoid receptor antagonists
Parviz, Y., Iqbal, J., Pitt, B., Adlam, D., Al‐Mohammad, A., & Zannad, F. M. (2015) · Trends in Endocrinology and Metabolism · doi:10.1016/j.tem.2015.01.007 · Cited by 33
Self-citationSudden Cardiac Death in Heart Failure
Klein, L., & Hsia, H. H. (2013) · Cardiology Clinics · doi:10.1016/j.ccl.2013.09.008 · Cited by 32
Schou, M., Gustafsson, F., Videbæk, L. M., Andersen, H., Toft, J. C., Nyvad, O., Ryde, H., Fog, L., Jensen, J. C. H., Nielsen, O. W., et al. (2013) · European Journal of Heart Failure · doi:10.1093/eurjhf/hft037 · Cited by 33
Anguita, M. P., Colet, J. C., Almenar, L., Crespo, M., Delgado, J. F., González-Costello, J., Hernández‐Madrid, A., Manito, N., de la Sota, E. P., Segovia, J. R., et al. (2012) · Revista Española de Cardiología · doi:10.1016/j.recesp.2012.07.013 · Cited by 33
Larik, F. A., Saeed, A., Shahzad, D., Faisal, M., El-Seedi, H. R., Mehfooz, H., & Channar, P. A. (2016) · Steroids · doi:10.1016/j.steroids.2016.12.010 · Cited by 33
Nilsson, E. D., de Deco, P., Trevisan, M., Bellocco, R., Lindholm, B., Lund, L. H., Coresh, J., & Carrero, J. J. (2018) · European Heart Journal - Quality of Care and Clinical Outcomes · doi:10.1093/ehjqcco/qcy019 · Cited by 33
Spironolactone and Outcomes in Older Patients with Heart Failure and Reduced Ejection Fraction
Bayoumi, E., Lam, P. H., Dooley, D. J., Singh, S. N., Faselis, C. J., Morgan, C. J., Patel, S. S., Sheriff, H. M., Mohammed, S. F., Palant, C. E., et al. (2018) · The American Journal of Medicine · doi:10.1016/j.amjmed.2018.09.011 · Cited by 33
Self-citationLeader, C. J., Moharram, M., Coffey, S., Sammut, I. A., Wilkins, G. W., & Walker, R. J. (2019) · PLoS ONE · doi:10.1371/journal.pone.0220837 · Cited by 33
Update of Pediatric Heart Failure
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Docherty, K. F., Bayés‐Genís, A., Butler, J., Coats, A. J. S., Drazner, M. H., Joyce, E., & Lam, C. S. P. (2022) · European Heart Journal Supplements · doi:10.1093/eurheartjsupp/suac113 · Cited by 40
“NYHA II) and an LVEF of ≤35% in the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF).(40) Here, the MRA led to a significant 37% reduction in the primary composite outcome of time to first HF hospitalization or cardiovascular death.”
MethodDixit, N. M., Parikh, N. U., Ziaeian, B., Jackson, N. M., & Fonarow, G. C. (2023) · JACC Heart Failure · doi:10.1016/j.jchf.2023.01.004 · Cited by 33
Linde, C. M., Curtis, A. B., Fonarow, G. C., Lee, K. L., Little, W. C., TANG, A. S. L., Levya, F., Momomura, S., Manrodt, C., Bergemann, T. L., et al. (2015) · International Journal of Cardiology · doi:10.1016/j.ijcard.2015.09.023 · Cited by 33
Al‐Khatib, S. M., Yancy, C. W., Solis, P., Becker, L. B., Benjamin, E. J., Carrillo, R. G., Ezekowitz, J. A., Fonarow, G. C., Kantharia, B. K., Kleinman, M. E., et al. (2016) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/hcq.0000000000000022 · Cited by 33
Aldosterone breakthrough in dogs with naturally occurring myxomatous mitral valve disease
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Hospitalizations for Heart Failure in the United States—A Sign of Hope
Gheorghiade, M., & D, E. B. M. (2011) · JAMA · doi:10.1001/jama.2011.1510 · Cited by 33
Dilated Cardiomyopathy: From Genetics to Clinical Management
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Recent Advances in the Emerging Therapeutic Strategies for Diabetic Kidney Diseases
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“The Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF) study demonstrated the beneficial effects of eplerenone for patients with heart failure, but its post hoc analysis found that patients with reduced eGFR had a higher incidence of hyperkalemia even when they received lower…”
Team-Based Care for Outpatients with Heart Failure
Creaser, J. W., DePasquale, E. C., Vandenbogaart, E., Rourke, D., Chaker, T., & Fonarow, G. C. (2015) · Heart Failure Clinics · doi:10.1016/j.hfc.2015.03.004 · Cited by 34
Renal Function in Advanced Heart Failure
Giamouzis, G., Butler, J., & Triposkiadis, F. K. (2011) · Congestive Heart Failure · doi:10.1111/j.1751-7133.2011.00240.x · Cited by 33
Tebbe, U., Tschöpe, C., Wirtz, J. H., Lokies, J., Turgonyi, E., Bramlage, P., Strunz, A. M., Lins, K., & Böhm, M. (2014) · Clinical Research in Cardiology · doi:10.1007/s00392-014-0678-2 · Cited by 32
“The rationale behind the underuse of MRAs in particular may be explained by the concerns about hyperkalaemia or gynecomastia, although clinical trials demonstrated a net clinical benefit in patients across NYHA classes II–IV and a reduced ventricular ejection fraction [24, 35, 36].”
BackgroundResultRenin-Angiotensin-Aldosterone System Inhibition
Mercier, K., Smith, H. D., & Biederman, J. I. (2014) · Primary Care Clinics in Office Practice · doi:10.1016/j.pop.2014.08.002 · Cited by 34
Cost-effectiveness of eplerenone in patients with systolic heart failure and mild symptoms
Lee, D., Wilson, K., Akehurst, R. L., Cowie, M., Zannad, F. M., Krum, H., van Veldhuisen, D. J., Vincent, J., Pitt, B., & McMurray, J. J. V. (2014) · Heart · doi:10.1136/heartjnl-2014-305673 · Cited by 32
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Le, H.-H., El-Khatib, C., Mombled, M., Guitarian, F., Al‐Gobari, M., Fall, M., Janiaud, P., Marchant, I., Cucherat, M., Bejan‐Angoulvant, T., et al. (2016) · PLoS ONE · doi:10.1371/journal.pone.0145958 · Cited by 32
“Sensitivity analysis Sensitivity analyses were tested for the biggest trial in each subgroup (among the greatest ones REMINDER [28], TOPCAT [14], EPHESUS [13], RALES [11], EMPHASIS-HF [33]) which had the greatest weight percentages, for eight open label/single blind/not reported design trials if applicable (Cicoira et…”
MethodInfluential
Metadata
- Authors
- Zannad, F., McMurray, J. J. V., Krum, H., van Veldhuisen, D. J., Swedberg, K., Shi, H., Vincent, J., Pocock, S. J., & Pitt, B.
- Affiliations
- Inserm (FR)
- Monash University (AU)
- University of Gothenburg (SE)
- Pfizer (United States) (US)
- London School of Hygiene & Tropical Medicine (GB)
- University of Michigan (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-01-06
- Volume
- 364
- Issue
- 1
- Pages
- 11-21
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2164705414
- Cited by
- 3,111
- References
- 27
- Citations by year
- 2026: 184 · 2025: 168 · 2024: 167 · 2023: 177 · 2022: 228 · 2021: 197 · 2020: 190 · 2019: 181 · 2018: 178 · 2017: 177 · 2016: 187 · 2015: 227 · 2014: 209 · 2013: 239 · 2012: 216
- FWCI
- 139.30
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Research Bank (Australian Catholic University) (submittedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Fibrosis and Remodeling
- Keywords
- eplerenone, mineralocorticoid receptor antagonists, heart failure with reduced ejection fraction, mild symptoms, heart failure hospitalization, cardiovascular mortality, hyperkalemia, ejection fraction
- MeSH terms
- Eplerenone, Aged, Mineralocorticoid Receptor Antagonists, Cardiovascular Agents, Cardiovascular Diseases, Combined Modality Therapy, Double-Blind Method, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Spironolactone, Proportional Hazards Models, Defibrillators, Implantable, Kaplan-Meier Estimate
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