The effect of spironolactone on morbidity and mortality in patients with severe heart failure

New England Journal of Medicine

Volumn 341, Issue 10, 1999, Pages 709-717

  Pitt, Bertram ^a,g   Zannad, Faiez ^b   Remme, Willem J ^c   Cody, Robert ^a   Castaigne, Alain ^d   Perez, Alfonso ^e   Palensky, Jolie ^f   Wittes, Janet ^f  

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b Centre d'Investigations Cliniques   (France)

^c Sticares Cardiovascular Research Foundation   (Netherlands)

^d HENRI MONDOR HOSPITAL   (France)

^e Global Medical Operations   (France)

^f University of Iowa   (United States)

^g UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ALDOSTERONE; ALDOSTERONE RECEPTOR; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CAPTOPRIL; DIGITALIS; DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENALAPRIL; LISINOPRIL; LOOP DIURETIC AGENT; PLACEBO; SPIRONOLACTONE;

ADULT; AGED; ARTICLE; CAUSE OF DEATH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; FEMALE; GYNECOMASTIA; HEART FAILURE; HUMAN; HYPERKALEMIA; MAJOR CLINICAL STUDY; MALE; MASTALGIA; MORBIDITY; MORTALITY; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SUDDEN DEATH;

AGED; ALDOSTERONE ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CAUSE OF DEATH; DIURETICS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GYNECOMASTIA; HEART DISEASES; HEART FAILURE, CONGESTIVE; HOSPITALIZATION; HUMANS; HYPERKALEMIA; MALE; MIDDLE AGED; RISK; SPIRONOLACTONE; SURVIVAL ANALYSIS;

EID: 0033517302     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199909023411001     Document Type: Article

References (44)

1. Dzau VJ, Colucci WS, Hollenberg NK, Williams GH. Relation of the renin-angiotensin-aldosterone system to clinical state in congestive heart failure. Circulation 1981;63:645-51.
2. Swedberg K, Eneroth P, Kjekshus J, Wilhelmsen L. Hormones regulating cardiovascular function in patients with severe congestive heart failure and their relation to mortality. Circulation 1990;82:1730-6.
3. Weber KT, Villarreal D. Aldosterone and antialdosterone therapy in congestive heart failure. Am J Cardiol 1993;71:Suppl:3A-11A.
4. Barr CS, Lang CC, Hanson J, Arnott M, Kennedy N, Struthers AD. Effects of adding spironolactone to an angiotensin-converting enzyme inhibitor in chronic congestive heart failure secondary to coronary artery disease. Am J Cardiol 1995;76:1259-65.
5. MacFadyen RJ, Barr CS, Struthers AD. Aldosterone blockade reduces vascular collagen turnover, improves heart rate variability and reduces early morning rise in heart rate in heart failure patients. Cardiovasc Res 1997; 35:30-4.
6. Wang W. Chronic administration of aldosterone depresses baroreceptor reflex function in the dog. Hypertension 1994;24:571-5.
7. Duprez DA, De Buyzere ML, Rietzschel ER, et al. Inverse relationship between aldosterone and large artery compliance in chronically treated heart failure patients. Eur Heart J 1998;19:1371-6.
8. Rocha R, Chander PN, Khanna K, Zuckerman A, Stier CT Jr. Mineralocorticoid blockade reduces vascular injury in stroke-prone hypertensive rats. Hypertension 1998;31:451-8.
9. Capoten tablets: captopril tablets. In: Physicians' desk reference. 52nd ed. Montvale, N.J.: Medical Economics, 1998:784-7.
10. Vasotec tablets: enalapril maleate. In: Physicians' desk reference. 52nd ed. Montvale, N.J.: Medical Economics, 1998:1771-4.
11. Cleland JG, Swedberg K, Poole-Wilson PA. Successes and failures of current treatment of heart failure. Lancet 1998;352:Suppl 1:SI19-SI28.
12. Cohn JN. The management of chronic heart failure. N Engl J Med 1996;335:490-8.
13. Borghi C, Boschi S, Ambrosioni E, Melandri G, Branzi A, Magnani B. Evidence of a partial escape of renin-angiotensin-aldosterone blockade in patients with acute myocardial infarction treated with ACE inhibitors. J Clin Pharmacol 1993;33:40-5.
14. Cleland JGF, Dargie HJ, Hodsman GP, et al. Captopril in heart failure: a double blind controlled trial. Br Heart J 1984;52:530-5.
15. Biollaz J, Brunncr HR, Gavras I, Waeber B, Gavras H. Antihypertensive therapy with MK 421: angiotensin II-renin relationships to evaluate efficacy of converting enzyme blockade. J Cardiovasc Pharmacol 1982;4: 966-72.
16. Staessen J, Lijnen P, Fagard R, Verschueren LJ, Amery A. Rise in plasma concentration of aldosterone during long-term angiotensin II suppression. J Endocrinol 1981;91:457-65.
17. The RALES Investigators. Effectiveness of spironolactone added to an angiotensin-ccmverting enzyme inhibitor and a loop diuretic for severe chronic congestive heart failure (the Randomized Aldactone Evaluation Study [RALES]). Am J Cardiol 1996;78:902-7.
18. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
19. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966;50:163-70.
20. Cox DR. Regression models and life-tables. J R Stat Soc [B] 1972;34: 187-202.
21. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:659-63.
22. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-56.
23. Lakatos E. Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics 1988;44:229-41. [Erratum, Biometrics 1988;44:923.]
24. The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293-302.
25. The CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure: results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987;316:1429-35.
26. The CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13.
27. The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med 1997;336:525-33.
28. Packer M, O'Connor CM, Ghali JK, et al. Effect of amlodipine on morbidity and mortality in severe chronic heart failure. N Engl J Med 1996;335:1107-14.
29. Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. N Engl J Med 1996;334:1349-55.
30. Zannad F. Angiotensin-converting enzyme inhibitor and spironolactone combination therapy: new objectives in congestive heart failure treatment. Am J Cardiol 1993;71:Suppl:34A-39A.
31. Pitt B. "Escape" of aldosterone production in patients with left ventricular dysfunction treated with an angiotensin converting enzyme inhibitor: implications for therapy. Cardiovasc Drugs Ther 1995;9:145-9.
32. Struthers AD. Aldosterone escape during angiotensin converting enzyme inhibitor therapy in chronic heart failure. J Card Fail 1996;2:47-54.
33. Weber KT, Brilla CG. Pathological hypertrophy and cardiac interstitium: fibrosis and renin-angiotensin-aldosterone system. Circulation 1991; 83:1849-65.
34. Brilla CG, Pick R, Tan LB, Janicki JS, Weber KT. Remodeling of the rat right and left ventricles in experimental hypertension. Circ Res 1990; 67:1355-64.
35. Klug D, Robert V, Swynghedauw B. Role of mechanical and hormonal factors in cardiac remodeling and the biologic limits of myocardial adaptation. Am J Cardiol 1993;71:Suppl:46A-54A.
36. Brilla CG, Matsubara LS, Weber KT. Anti-aldosterone treatment and the prevention of myocardial fibrosis in primary and secondary hyperaldosteronism. J Mol Cell Cardiol 1993;25:563-75.
37. Barr CS, Naas A, Freeman M, Lang CC, Struthers AD. QT dispersion and sudden unexpected death in chronic heart failure. Lancet 1994;343: 327-9.
38. Hobbs RE. Results of the ATLAS study - high or low doses of ACE inhibitors for heart failure? Cleve Clin J Med 1998;65:539-42.
39. 2+ concentration and aldosterone production in rat adrenal glomcrulosa cells: interaction with potassium and angiotensin-II. Endocrinology 1991;128:2639-44.
40. Szalay KS, Beck M, Toth M, de Chatel R. Interactions between ouabain, atrial natriuretic peptide, angiotensin-II and potassium: effects on rat zona glomerulosa aldosterone production. Life Sci 1998;62:1845-52.
41. Okubo S, Niimura F, Nishimura H, et al. Angiotensin-independent mechanism for aldosterone synthesis during chronic extracellular fluid volume depletion. J Clin Invest 1997;99:855-60.
42. Aldactone: spironolactone. In: Physicians' desk reference. 53rd ed. Montvale, N.J.: Medical Economics, 1999:2928-9.
43. Jeunemaitre X, Chatellier G, Kreft-Jais C, et al. Efficacy and tolerance of spironolactone in essential hypertension. Am J Cardiol 1987;60:820-5.
44. de Gasparo M, Joss U, Ramjoué HP, et al. Three new epoxy-spirolactone derivatives: characterization in vivo and in vitro. J Pharmacol Exp Ther 1987;240:650-6.