Increased mortality among patients taking digoxin - Analysis from the AFFIRM study

European Heart Journal

Volumn 34, Issue 20, 2013, Pages 1481-1488

  Whitbeck, Matthew G ^a   Charnigo, Richard J ^a   Khairy, Paul ^a   Ziada, Khaled ^a   Bailey, Alison L ^a   Zegarra, Milagros M ^a   Shah, Jignesh ^a   Morales, Gustavo ^a   MacAulay, Tracy ^a   Sorrell, Vincent L ^a   Campbell, Charles L ^a   Gurley, John ^a   Anaya, Paul ^a   Nasr, Hafez ^a   Bai, Rong ^a   Di Biase, Luigi ^a   Booth, David C ^a   Jondeau, Guillaume ^a   Natale, Andrea ^a   Roy, Denis ^a   Smyth, Susan ^a   Moliterno, David J ^a   Elayi, Claude S ^a   more..

^a UNIVERSITY OF KENTUCKY   (United States)

Author keywords

Arrhythmias; Atrial fibrillation; Congestive heart failure; Digoxin; Mortality

Indexed keywords

AMIODARONE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR;

AGED; ARTICLE; CARDIOVASCULAR MORTALITY; CAUSE OF DEATH; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; FEMALE; FOLLOW UP; HEART ATRIUM FIBRILLATION; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART RATE; HEART RHYTHM; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEX DIFFERENCE;

ARRHYTHMIAS; ATRIAL FIBRILLATION; CONGESTIVE HEART FAILURE; DIGOXIN; MORTALITY;

AGED; ANTI-ARRHYTHMIA AGENTS; ATRIAL FIBRILLATION; CAUSE OF DEATH; DIGOXIN; FEMALE; HEART FAILURE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; PROPORTIONAL HAZARDS MODELS;

EID: 84878304958     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehs348     Document Type: Article

References (41)

1. Wolf PA, Abbott RD, Kanne WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham study. Stroke 1991;22:983-988.
2. Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of Atrial Fibrillation on the Risk of Death: the Framingham heart study. Circulation 1998;98:946-952.
3. Conen D, Chae CU, Glynn RJ, Tedrow UB, Everett BM, Buring JE, Albert CM. Risk of death and cardiovascular events in initially healthy women with new-onset atrial fibrillation. J Am Med Assoc 2011;305:2080-2087.
4. Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD, Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med 2002;347:1825-1833.
5. Uretsky B, Young JB, Shahidi FE, Yellen LG, Harrison MC, Jolly MK. Randomized study assessing the effect of digoxin withdrawal in patients with mild to moderate chronic congestive heart failure: results of the Proved trial. J Am Coll Cardiol 1993; 22:955-962.
6. Gheorghiade M, Adams KF, Colucci WS. Digoxin in the management of cardiovascular disorders. Circulation 2004;109:2959-2964.
7. Rathore SS, Curtis JP, Wang Y, Bristow MR, Krumholz HM. Association of serum digoxin concentration and outcomes in patients with heart failure. J Am Med Assoc 2003;289:871-878.
8. Chan KE, Lazarus JM, Hakim RM. Digoxin associates with mortality in ESRD. J Am Soc Nephrol 2010;21:1550-1559.
9. Packer M, Gheorghiade M, Young JB, Costantini PJ, Adams KF, Cody RJ, Smith LK, Van Voorhees L, Gourley LA, Jolly MK, RADIANCE Study investigators. Withdrawal of digoxin from patients with chronic heart failure treated with angiotensin-converting-enzyme inhibitors. N Engl J Med 1993;329:1-7.
10. The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med 1997;336:525-533.
11. Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD, Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) study. Circulation 2004;109:1509-1513.
12. Hallberg P, Lindback J, Lindahl B, Stenestrand U, Melhus H, RIKS-HIA group. Digoxin and mortality in atrial fibrillation: a prospective cohort study. Eur J Clin Pharmacol 2007;63:1201-1202.
13. Elayi CS, Whitbeck MG, Charnigo R, Shah J, Macaulay TE, Morales G, Gurley JC, Kakavand B, Thal S, Ching CK, Khaykin Y, Verma A, Barrett C, Bai R, Di Biase L, Patwardhan A, Moliterno DJ, Natale A. Is there an association between external cardioversions and long term mortality and morbidity - insights from the AFFIRM study. Circ Arrhythm Electrophysiol 2011;4:465-469.
14. Domanski M, Fleg J, Bristow M, Knox S. The effect of gender on outcome in digitalis-treated heart failure patients. J Card Fail 2005;11:83-86.
15. Butler J, Anand IS, Kuskowski MA, Rector T, Carson P, Cohn JN. Digoxin use and heart failure outcomes: results from the Valsartan Heart Failure Trial (Val-HeFT). Congest Heart Fail 2010;16:191-195.
16. WitheringW. An account of the foxglove and some of its medical uses, with practical remarks on dropsy, and other diseases. In: Willins FA, Keys TE (eds). Classics of Cardiology. Vol. 1. New York, NY: Henry Schuman, Dover Publications; 1941:231-252.
17. Gheorghiade M, Van Veldhuisen DJ, Colucci WS. Contemporary use of digoxin in the management of cardiovascular disorders. Circulation 2006;113:2556-2564.
18. Roy D, Talajic M, Nattel S, Wyse GD, Dorian P, Lee KL, Kerry L, Bourassa MG, Arnold JMO, Buxton AE, Camm JA, Connolly SJ, Dubuc M, Ducharme A, Guerra PG, Hohnloser SH, Lambert J, Le Heuzey JY, O'Hara G, Pedersen OD, Rouleau JL, Singh BN, Stevenson LW, Stevenson WG, Thibault B, Waldo AL, Atrial Fibrillation and Congestive Heart Failure Investigators. Rhythm control versus rate control for atrial fibrillation and heart failure. N Engl J Med 2008; 358:2667-2677.
19. Poole-Wilson PA, Swedberg K, Cleland JG, Di Lenarda A, Hanrath P, Komajda M, Lubsen J, Lutiger B, Metra M, Remme WJ, Torp-Pedersen C, Scherhag A, Skene A, Carvedilol Or Metoprolol European Trial Investigators. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. Lancet 2003;362:9377.
20. The ACTIVE I Investigators. Irbesartan in patients with atrial fibrillation. N Engl J Med 2011;364:928-938.
21. Brodsky MA, Greene HL, The AFFIRM Investigators. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study: approaches to control rate in atrial fibrillation. J Am Coll Cardiol 2004;43:1201-1208.
22. Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, the Race II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med 2010;362:1363-1373.
23. Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, Said SA, Darmanata JI, Timmermans AJ, Tijssen JG, Crijns HJ, Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation Study Group. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med 2002;347:1834-1840.
24. Zarowitz BJ, Gheorghiade M. Optimal heart rate control for patients with chronic atrial fibrillation: are pharmacologic choices truly changing? Am Heart J 1992;123: 1401-1403.
25. Eichhorn EJ, Gheorghiade M. Digoxin: current use and approach to toxicity. Prog Cardiovasc Dis 2002;44:251-266.
26. Fauchier L, Grimard C, Pierre B, Nonin E, Gorin L, Rauzy B, Cosnay P, Babuty D, Charbonnier B. Comparison of beta blocker and digoxin alone and in combination for management of patients with atrial fibrillation and heart failure. Am J Cardiol 2009;103:248-254.
27. Castagno D, Petrie MC, Claggett B, McMurray J. Should we SHIFT our thinking about digoxin? Observations on ivabradine and heart rate reduction in heart failure. Eur Heart J 2012;33:1137-1141.
28. Binder L, Fredrickson L. Poisonings in laboratory personnel and health care professionals. Am J Emerg Med 1991;9:11-15.
29. Englund G, Hallberg P, Artursson P, Michae-lsson K, Melhus H. Association between the number of coadministered P-glycoprotein inhibitors and serum digoxin levels in patients on therapeutic drug monitoring. BMC Med 2004;2:8.
30. Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum Á, Blomstro?m P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacre'taz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbu?chel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsa'nyi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH, PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med 2011;365: 2268-2276.
31. Nattel S. Dronedarone in atrial fibrillation - Jekyll and Hyde? N Engl J Med 2011; 365:2321-2322.
32. Ahmed A, Rich MW, Love TE, Lloyd-Jones DM, Aban IB, Colucci WS, Adams KF, Gheorghiade M. Digoxin and reduction in mortality and hospitalization in heart failure: a comprehensive post hoc analysis of the DIG trial. Eur Heart J 2006;27: 178-186.
33. Slatton ML, Irani WN, Hall SA. Does digoxin provide additional hemodynamic and autonomic benefit at higher doses in patients with mild to moderate heart failure and normal sinus rhythm? J Am Coll Cardiol 1997;29:1206-1213.
34. Gheorghiade M, Ferguson D. Digoxin: a neurohormonal modulator in heart failure? Circulation 1991;84:2181-2186.
35. Ferguson DW, Berg WJ, Sanders JS, Roach PJ, Kempf JS, Kienzle MG. Sympathoinhibitory responses to digitalis glycosides in heart failure patients: direct evidence from sympathetic neural recordings. Circulation 1989;80:65-77.
36. Adams KF Jr, Gheorghiade M, Uretsky BF, Patterson JH, Schwartz TA, Young JB. Clinical benefits of low serum digoxin concentrations in heart failure. J Am Coll Cardiol 2002;39:946-953.
37. Ahmed A, Waagstein F, Pitt B, White M, Zannad F, Young JB, Rahimtoola SH. Effectiveness of digoxin in reducing one-year mortality in chronic heart failure in the digitalis investigation group trial. Am J Cardiol 2009;103:82-87.
38. Goldman RH, Coltart J, Friedman JP, Nola GT, Berke DK, Schweizer E, Harrison DC. The inotropic effects of digoxin in hyperkalemia: relation to (Na+, K+)-ATPase inhibition in the intact animal. Circulation 1973;48:830-838.
39. Pouleur AC, Barkoudah E, Uno H, Skali H, Finn PV, Zelenkofske SL, Belenkov YN, Mareev V, Velazquez EJ, Rouleau JL, Maggioni AP, Køber L, Califf RM, McMurray JJ, Pfeffer MA, Solomon SD, VALIANT Investigators. Pathogenesis of sudden unexpected death in a clinical trial of patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. Circulation 2010;122:597-602.
40. Steinberg JS, Sadaniantz A, Kron J, Krahn A, Denny DM, Daubert J, Campbell WB, Havranek E, Murray K, Olshansky B, O'Neill G, Sami M, Schmidt S, Storm R, Zabalgoitia M, Miller J, Chandler M, Nasco EM, Greene HL. Analysis of causespecific mortality in the atrial fibrillation follow-up investigation of rhythm management (AFFIRM) study. Circulation 2004;109:1973-1980.
41. Rathmore SS,Wang Y, Krumholz M. Sex-based differences in the effect of digoxin for the treatment of heart failure. N Engl J Med 2002;347:1403-1411.