Effects of digoxin at low serum concentrations on mortality and hospitalization in heart failure: A propensity-matched study of the DIG trial

International Journal of Cardiology

Volumn 123, Issue 2, 2008, Pages 138-146

  Ahmed, Ali ^a   Pitt, Bertram ^b   Rahimtoola, Shahbudin H ^c   Waagstein, Finn ^d   White, Michel ^e   Love, Thomas E ^f   Braunwald, Eugene ^g  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^d Sahlgrenska Sjukhuset   (Sweden)

^e MONTREAL HEART INSTITUTE   (Canada)

^f CASE WESTERN RESERVE UNIVERSITY   (United States)

^g BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Digoxin; Heart failure; Hospitalization; Low dose; Low serum concentration; Mortality

Indexed keywords

DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; PLACEBO;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIASTOLIC HEART FAILURE; DRUG BLOOD LEVEL; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMAN; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTIVARIATE ANALYSIS; PRIORITY JOURNAL; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; SYSTOLIC HEART FAILURE; TREATMENT OUTCOME;

AGED; DIGOXIN; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES;

EID: 37149000570     PISSN: 01675273     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijcard.2006.12.001     Document Type: Article

References (38)

1. Rahimtoola S.H. Digitalis therapy for patients in clinical heart failure. Circulation 109 (2004) 2942-2946
2. Gheorghiade M., van Veldhuisen D.J., and Colucci W.S. Contemporary use of digoxin in the management of cardiovascular disorders. Circulation 113 (2006) 2556-2564
3. The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med 336 (1997) 525-533
4. Ahmed A., Rich M.W., Love T.E., et al. Digoxin and reduction in mortality and hospitalization in heart failure: a comprehensive post hoc analysis of the DIG trial. Eur Heart J 27 (2006) 178-186
5. Ahmed A., Rich M.W., Fleg J.L., et al. Effects of digoxin on morbidity and mortality in diastolic heart failure: the ancillary digitalis investigation group trial. Circulation 114 (2006) 397-403
6. Hunt S.A., Abraham W.T., Chin M.H., et al. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). Circulation 112 (2005) e154-e235
7. Swedberg K., Cleland J., Dargie H., et al. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Eur Heart J 26 (2005) 1115-1140
8. Adams K., Lindenfeld J., Arnold J., et al. Executive Summary: HFSA 2006 Comprehensive Heart Failure Practice Guideline. J Card Fail 12 (2006) 10-38
9. Arnold J.M., Liu P., Demers C., et al. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management. Can J Cardiol 22 (2006) 23-45
10. Fonarow G.C., Yancy C.W., and Heywood J.T. Adherence to heart failure quality-of-care indicators in US hospitals: analysis of the ADHERE Registry. Arch Intern Med 165 (2005) 1469-1477
11. Brophy J.M. Rehabilitating digoxin. Eur Heart J 27 (2006) 127-129
12. Pitt B. Whither withering? The role of digoxin in patients with heart failure due to systolic left ventricular dysfunction in sinus rhythm. J Card Fail 12 (2006) 347-348
13. Smith T.W., Butler Jr. V.P., and Haber E. Determination of therapeutic and toxic serum digoxin concentrations by radioimmunoassay. N Engl J Med 281 (1969) 1212-1216
14. Adams Jr. K.F., Patterson J.H., Gattis W.A., et al. Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis. J Am Coll Cardiol 46 (2005) 497-504
15. Rathore S.S., Wang Y., and Krumholz H.M. Sex-based differences in the effect of digoxin for the treatment of heart failure. N Engl J Med 347 (2002) 1403-1411
16. Concato J., Feinstein A.R., and Holford T.R. The risk of determining risk with multivariable models. Ann Intern Med 118 (1993) 201-210
17. Rubin D.B. Using propensity score to help design observational studies: application to the tobacco litigation. Health Serv Outcomes Res Methodol 2 (2001) 169-188
18. Rosenbaum P.R., and Rubin D.B. The central role of propensity score in observational studies for causal effects. Biometrika 70 (1983) 41-55
19. Michels K.B., and Braunwald E. Estimating treatment effects from observational data: dissonant and resonant notes from the SYMPHONY trials. JAMA 287 (2002) 3130-3132
20. Ahmed A., Husain A., Love T.E., et al. Heart failure, chronic diuretic use, and increase in mortality and hospitalization: an observational study using propensity score methods. Eur Heart J 27 (2006) 1431-1439
21. Normand S.T., Landrum M.B., Guadagnoli E., et al. Validating recommendations for coronary angiography following acute myocardial infarction in the elderly: a matched analysis using propensity scores. J Clin Epidemiol 54 (2001) 387-398
22. The Digitalis Investigation Group. Rationale, design, implementation, and baseline characteristics of patients in the DIG trial: a large, simple, long-term trial to evaluate the effect of digitalis on mortality in heart failure. Control Clin Trials 17 (1996) 77-97
23. Levey A.S., Bosch J.P., Lewis J.B., Greene T., Rogers N., and 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 130 (1999) 461-470
24. Levesque R. Macro. In: Levesque R, ed. SPSS® Programming and Data Management, 2nd Edition. A Guide for SPSS® and SAS® Users. Available online at: http://www.spss.com/spss/data_management_book.htm. Last access date: June 4, 2005. Vol 2nd Edition. Chicago, IL: SPSS Inc.
25. Rosenbaum P.R., and Rubin D.B. The bias due to incomplete matching. Biometriks 41 (1985) 103-116
26. D'Agostino Jr. R.B. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med 17 (1998) 2265-2281
27. SPSS for Windows, Rel. 14. Version (2006), SPSS Inc., Chicago, IL
28. Gheorghiade M., and Ferguson D. Digoxin. A neurohormonal modulator in heart failure?. Circulation 84 (1991) 2181-2186
29. Torretti J., Hendler E., Weinstein E., Longnecker R.E., and Epstein F.H. Functional significance of Na-K-ATPase in the kidney: effects of ouabain inhibition. Am J Physiol 222 (1972) 1398-1405
30. Montanaro D., Antonello A., Baggio B., Finotti P., Melacini P., and Ferrari M. Effects of digoxin on plasma renin activity in hypertensive patients. Int J Clin Pharmacol Ther Toxicol 18 (1980) 322-323
31. Covit A.B., Schaer G.L., Sealey J.E., Laragh J.H., and Cody R.J. Suppression of the renin-angiotensin system by intravenous digoxin in chronic congestive heart failure. Am J Med 75 (1983) 445-447
32. Thames M.D. Acetylstrophanthidin-induced reflex inhibition of canine renal sympathetic nerve activity mediated by cardiac receptors with vagal afferents. Circ Res 44 (1979) 8-15
33. Ferguson D.W., Berg W.J., Sanders J.S., Roach P.J., Kempf J.S., and Kienzle M.G. Sympathoinhibitory responses to digitalis glycosides in heart failure patients. Direct evidence from sympathetic neural recordings. Circulation 80 (1989) 65-77
34. Ruelaz R.A., and Rahimtoola S.H. Was it digoxin toxicity?...very likely. J Card Fail 11 (2005) 87-90
35. Rothwell P.M. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 365 (2005) 176-186
36. Rosenbaum P.R. Sensitivity to hidden bias. In: Rosenbaum P.R. (Ed). Observational Studies. 2 ed. (2002), Springer-Verlag, New York 110-124
37. Pitt B., Zannad F., Remme W.J., et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 341 (1999) 709-717
38. Eichhorn EJ, Lukas MA, Wu B, Shusterman N. Effect of concomitant digoxin and carvedilol therapy on mortality and morbidity in patients with chronic heart failure. Am J Cardiol 2000;86:1032-5, A1010-31.