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Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure).
J Am Coll Cardiol 2013; 62(17):1585-93JACC

Abstract

OBJECTIVES

The study sought to investigate the safety and efficacy of eplerenone in patients at high risk for hyperkalemia or worsening renal function (WRF) in EMPHASIS-HF, a trial that enrolled patients at least 55 years old with heart failure and reduced ejection fraction (HF-REF), in New York Heart Association (NYHA) functional class II and with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73 m(2) and serum potassium <5.0 mmol/l. Patients were receiving optimal therapy and most had been hospitalized for a cardiovascular reason within 180 days of inclusion.

BACKGROUND

Underuse of eplerenone in patients with HF-REF may be due to fear of inducing hyperkalemia or WRF in high-risk patients.

METHODS

This was a pre-specified analysis of subgroups of patients at high risk of hyperkalemia or WRF (patients ≥ 75 years of age, with diabetes, with eGFR <60 ml/min/1.73 m(2), and with systolic blood pressure < median of 123 mm Hg), examining the major safety measures (potassium >5.5, >6.0, and <3.5 mmol/l; hyperkalemia leading to study-drug discontinuation or hospitalization; and hospitalization for WRF) as well as the primary outcome (hospitalization for HF or cardiovascular mortality).

RESULTS

In all high-risk subgroups, patients treated with eplerenone had an increased risk of potassium >5.5 mmol/l but not of potassium >6.0 mmol/l, and of hospitalization for hyperkalemia or discontinuation of study medication due to adverse events. Eplerenone was effective in reducing the primary composite endpoint in all subgroups.

CONCLUSIONS

In patients with chronic HF-REF, in NYHA functional class II, and meeting specific inclusion and exclusion criteria, including an eGFR >30 ml/min/1.73 m(2) and potassium <5.0 mmol/l, eplerenone was both efficacious and safe when carefully monitored, even in subgroups at high risk of developing hyperkalemia or WRF. (A Comparison Of Outcomes In Patients In New York Heart Association [NYHA] Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines [EMPHASIS-HF Study]; NCT00232180).

Authors+Show Affiliations

Centre d'Investigation Clinique Inserm CIC-P 9501, Centre Hospitalier Universitaire de Nancy, Nancy, France; Clermont University, Université d'Auvergne, UMR6284, and the Department of Cardiology, Clermont-Ferrand, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23810881

Citation

Eschalier, Romain, et al. "Safety and Efficacy of Eplerenone in Patients at High Risk for Hyperkalemia And/or Worsening Renal Function: Analyses of the EMPHASIS-HF Study Subgroups (Eplerenone in Mild Patients Hospitalization and SurvIval Study in Heart Failure)." Journal of the American College of Cardiology, vol. 62, no. 17, 2013, pp. 1585-93.
Eschalier R, McMurray JJ, Swedberg K, et al. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013;62(17):1585-93.
Eschalier, R., McMurray, J. J., Swedberg, K., van Veldhuisen, D. J., Krum, H., Pocock, S. J., ... Pitt, B. (2013). Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). Journal of the American College of Cardiology, 62(17), pp. 1585-93. doi:10.1016/j.jacc.2013.04.086.
Eschalier R, et al. Safety and Efficacy of Eplerenone in Patients at High Risk for Hyperkalemia And/or Worsening Renal Function: Analyses of the EMPHASIS-HF Study Subgroups (Eplerenone in Mild Patients Hospitalization and SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013 Oct 22;62(17):1585-93. PubMed PMID: 23810881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). AU - Eschalier,Romain, AU - McMurray,John J V, AU - Swedberg,Karl, AU - van Veldhuisen,Dirk J, AU - Krum,Henry, AU - Pocock,Stuart J, AU - Shi,Harry, AU - Vincent,John, AU - Rossignol,Patrick, AU - Zannad,Faiez, AU - Pitt,Bertram, AU - ,, Y1 - 2013/06/27/ PY - 2013/01/04/received PY - 2013/04/13/revised PY - 2013/04/15/accepted PY - 2013/7/2/entrez PY - 2013/7/3/pubmed PY - 2013/12/16/medline KW - ACE-I KW - ARB KW - BB KW - CI KW - CKD KW - DM KW - HF-REF KW - HR KW - MRA KW - SBP KW - WRF KW - angiotensin receptor blocker KW - angiotensin-converting enzyme inhibitor KW - beta-adrenergic receptor blocking agent KW - chronic kidney disease KW - confidence interval KW - diabetes KW - diabetes mellitus KW - eGFR KW - efficacy KW - elderly KW - eplerenone KW - estimated glomerular filtration rate KW - hazard ratio KW - heart failure with a reduced left ventricular ejection fraction KW - mineralocorticoid receptor antagonist KW - safety KW - systolic blood pressure KW - worsening renal function SP - 1585 EP - 93 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 62 IS - 17 N2 - OBJECTIVES: The study sought to investigate the safety and efficacy of eplerenone in patients at high risk for hyperkalemia or worsening renal function (WRF) in EMPHASIS-HF, a trial that enrolled patients at least 55 years old with heart failure and reduced ejection fraction (HF-REF), in New York Heart Association (NYHA) functional class II and with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73 m(2) and serum potassium <5.0 mmol/l. Patients were receiving optimal therapy and most had been hospitalized for a cardiovascular reason within 180 days of inclusion. BACKGROUND: Underuse of eplerenone in patients with HF-REF may be due to fear of inducing hyperkalemia or WRF in high-risk patients. METHODS: This was a pre-specified analysis of subgroups of patients at high risk of hyperkalemia or WRF (patients ≥ 75 years of age, with diabetes, with eGFR <60 ml/min/1.73 m(2), and with systolic blood pressure < median of 123 mm Hg), examining the major safety measures (potassium >5.5, >6.0, and <3.5 mmol/l; hyperkalemia leading to study-drug discontinuation or hospitalization; and hospitalization for WRF) as well as the primary outcome (hospitalization for HF or cardiovascular mortality). RESULTS: In all high-risk subgroups, patients treated with eplerenone had an increased risk of potassium >5.5 mmol/l but not of potassium >6.0 mmol/l, and of hospitalization for hyperkalemia or discontinuation of study medication due to adverse events. Eplerenone was effective in reducing the primary composite endpoint in all subgroups. CONCLUSIONS: In patients with chronic HF-REF, in NYHA functional class II, and meeting specific inclusion and exclusion criteria, including an eGFR >30 ml/min/1.73 m(2) and potassium <5.0 mmol/l, eplerenone was both efficacious and safe when carefully monitored, even in subgroups at high risk of developing hyperkalemia or WRF. (A Comparison Of Outcomes In Patients In New York Heart Association [NYHA] Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines [EMPHASIS-HF Study]; NCT00232180). SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/23810881/Safety_and_efficacy_of_eplerenone_in_patients_at_high_risk_for_hyperkalemia_and/or_worsening_renal_function:_analyses_of_the_EMPHASIS_HF_study_subgroups__Eplerenone_in_Mild_Patients_Hospitalization_And_SurvIval_Study_in_Heart_Failure__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(13)02512-6 DB - PRIME DP - Unbound Medicine ER -