Renal function stratified dose comparisons of eplerenone versus placebo in the EMPHASIS-HF trial

European Journal of Heart Failure

Volumn 21, Issue 3, 2019, Pages 345-351

  Ferreira, João Pedro ^a,b   Abreu, Paula ^c   McMurray, John J V ^d   van Veldhuisen, Dirk J ^e   Swedberg, Karl ^f   Pocock, Stuart J ^g   Vincent, John ^c   Lins, Katharina ^c   Rossignol, Patrick ^a   Pitt, Bertram ^h   Zannad, Faiez ^a  

^a UNIVERSITÉ DE LORRAINE   (France)

^b University of Porto   (Portugal)

^c PFIZER INC   (United States)

^d UNIVERSITY OF GLASGOW   (United Kingdom)

^e UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^f UNIVERSITY OF GOTHENBURG   (Sweden)

^g LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^h UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

Author keywords

Eplerenone; Heart failure; Renal function; Stratification; Treatment dose

Indexed keywords

EPLERENONE; PLACEBO; MINERALOCORTICOID ANTAGONIST;

AGED; ARTICLE; CARDIOVASCULAR MORTALITY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; ESTIMATED GLOMERULAR FILTRATION RATE; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMAN; HYPERKALEMIA; KIDNEY FAILURE; KIDNEY FUNCTION; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; BIOAVAILABILITY; DOSE RESPONSE; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; GLOMERULUS FILTRATION RATE; KIDNEY FUNCTION TEST; MIDDLE AGED; MORTALITY; PATHOPHYSIOLOGY; PROCEDURES;

AGED; BIOLOGICAL AVAILABILITY; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; EPLERENONE; FEMALE; GLOMERULAR FILTRATION RATE; HEART FAILURE; HOSPITALIZATION; HUMANS; KIDNEY FUNCTION TESTS; MALE; MIDDLE AGED; MINERALOCORTICOID RECEPTOR ANTAGONISTS; PHARMACOVIGILANCE; TREATMENT OUTCOME;

EID: 85061573295     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1002/ejhf.1400     Document Type: Article

References (15)

1. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2016;18:891–975.
2. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos G, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol 2016;68:1476–1488.
3. Maggioni AP, Anker SD, Dahlstrom U, Filippatos G, Ponikowski P, Zannad F, Amir O, Chioncel O, Leiro MC, Drozdz J, Erglis A, Fazlibegovic E, Fonseca C, Fruhwald F, Gatzov P, Goncalvesova E, Hassanein M, Hradec J, Kavoliuniene A, Lainscak M, Logeart D, Merkely B, Metra M, Persson H, Seferovic P, Temizhan A, Tousoulis D, Tavazzi L; Heart Failure Association of the ESC. Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC Heart Failure Long-Term Registry. Eur J Heart Fail 2013;15:1173–1184.
4. Lam PH, Dooley DJ, Fonarow GC, Butler J, Bhatt DL, Filippatos GS, Deedwania P, Forman DE, White M, Fletcher RD, Arundel C, Blackman MR, Adamopoulos C, Kanonidis IE, Aban IB, Patel K, Aronow WS, Allman RM, Anker SD, Pitt B, Ahmed A. Similar clinical benefits from below-target and target dose enalapril in patients with heart failure in the SOLVD Treatment trial. Eur J Heart Fail 2018;20:359–369.
5. Khan MS, Fonarow GC, Ahmed A, Greene SJ, Vaduganathan M, Khan H, Marti C, Gheorghiade M, Butler J. Dose of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers and outcomes in heart failure: a meta-analysis. Circ Heart Fail 2017;10:e003956.
6. Bristow MR, Gilbert EM, Abraham WT, Adams KF, Fowler MB, Hershberger RE, Kubo SH, Narahara KA, Ingersoll H, Krueger S, Young S, Shusterman N. Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. MOCHA Investigators. Circulation 1996;94:2807–2816.
7. Ferreira JP, Mentz RJ, Pizard A, Pitt B, Zannad F. Tailoring mineralocorticoid receptor antagonist therapy in heart failure patients: are we moving towards a personalized approach? Eur J Heart Fail 2017;19:974–986.
8. Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med 2011;364:11–21.
9. Pitt B, Williams G, Remme W, Martinez F, Lopez-Sendon J, Zannad F, Neaton J, Roniker B, Hurley S, Burns D, Bittman R, Kleiman J. The EPHESUS trial: eplerenone in patients with heart failure due to systolic dysfunction complicating acute myocardial infarction. Eplerenone Post-AMI Heart Failure Efficacy and Survival Study. Cardiovasc Drugs Ther 2001;15:79–87.
10. Collier TJ, Pocock SJ, McMurray JJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. The impact of eplerenone at different levels of risk in patients with systolic heart failure and mild symptoms: insight from a novel risk score for prognosis derived from the EMPHASIS-HF trial. Eur Heart J 2013;34:2823–2829.
11. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999;130:461–470.
12. Packer M, Poole-Wilson PA, Armstrong PW, Cleland JG, Horowitz JD, Massie BM, Rydén L, Thygesen K, Uretsky BF. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. ATLAS Study Group. Circulation 1999;100:2312–2318.
13. Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet 2009;374:1840–1848.
14. Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol 1999;52:19–26.
15. Juurlink DN, Mamdani MM, Lee DS, Kopp A, Austin PC, Laupacis A, Redelmeier DA. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. N Engl J Med 2004;351:543–551.