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#139 Digoxin: Old friend or best left on the shelf?

Does digoxin change clinical outcomes for patients with congestive heart failure or atrial fibrillation?

For systolic congestive heart failure (CHF), a randomized controlled trial (RCT) demonstrated that digoxin decreases CHF related hospitalizations (for one in 13 patients) without altering mortality. Stopping digoxin in stable CHF patients may worsen symptoms. Post-hoc analysis suggests low serum digoxin levels may actually decrease mortality. Cohort data for atrial fibrillation (AF) or CHF suggests digoxin increases mortality, although cause and effect is not established. 

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  • Systolic CHF:  
    • High quality RCT of 6,800 patients (NYHA class II-III, mean age 63) on digoxin (median 0.25 mg/day) or placebo1 which contributed 98% of outcomes to subsequent systematic review2 found at three years: 
      • Overall mortality or hospitalizations: No difference. 
      • CHF hospitalizations: 27% Digoxin versus 35% placebo, Number Needed to Treat (NNT)=13. 
      • Limitation: Study occurred before routine beta blocker (BB) use.  
    • Post-hoc analysis:3  
      • Digoxin levels: 
        • <0.9 ng/ml: 6% absolute lower mortality and overall hospitalizations rate compared to placebo. 
        • >1.2 ng/ml: 12% absolute higher mortality. 
    • 12 week RCTs of Digoxin withdrawal in stable CHF resulted in:4,5 
      • Clinical deterioration (necessitating study withdrawal)4 or treatment failure (adding/increasing CHF meds, emergency department visit/admission)5 
      • Number Needed to Harm ~5.4,5 
      • Deterioration more likely in patients older, not on angiotensin converting enzyme inhibitors (ACEI) or more cardiomegaly/CHF symptoms.6 
  • AF:  
    • A systematic review of 12 cohort studies (235,047 patients)7 including three largest studies from US,8 Sweden,9 and Canada10 using digoxin post hospital discharge8,9 or outpatient visit9,10 demonstrated a 29% increased mortality associated with digoxin (HR 1.29; 95% CI, 1.21-1.39).  
      • Limitations: Unsure if possible residual confounding (patients receiving digoxin are sicker). 
  • Current guidelines recommend digoxin after: 
    • Diuretics, ACEI, BBs, and aldosterone antagonists in CHF.11 
    • Calcium channel blockers or BBs in AF.12 
  • Clinical symptoms, age, and renal function should guide digoxin dosing, digoxin levels being ordered if questioning toxicity. 
  • Digoxin toxicity typically presents with cardiac arrhythmias, visual, or gastrointestinal symptoms13 and remains a relatively common reason for hospitalizations in the elderly.14 

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  • Michael R Kolber BSc MD CCFP MSc
  • Tafi Madzimure MBChB

1. The Digitalis Investigation Group Investigators. N Engl J Med. 1997; 336:525-33.

2. Hood WB Jr, Dans AL, Guyatt GH, et al. Cochrane Database Syst Rev. 2014; 4:CD002901.

3. Rathore SS, Curtis JP, Wang Y, et al. JAMA. 2003; 289:871-8.

4. Packer M, Gheorghiade M, Young JB, et al. N Engl J Med. 1993; 329:1-7.

5. Uretsky BF, Young JB, Shahidi FE, et al. J Am Coll Cardiol. 1993; 22(4):955-62.

6. Adams KF Jr, Gheorghiade M, Uretsky BF, et al. Am Heart J. 1998; 135:389-97.

7. Vamos M, Erath JW, Hohnloser SH. Eur Heart J. 2015 May 4. pii: ehv143 [Epub ahead of print]

8. Turakhia MP, Santangeli P, Winkelmayer WC, et al. J Am Coll Cardiol. 2014; 64: 660-8.

9. Hallberg P, Lindbäck J, Lindahl B, et al. Eur J Clin Pharmacol. 2007; 63:959-71.

10. Shah R, Meytal A, Cynthia A. Am J Cardiol. 2014; 114:401-6.

11. McKelvie RS, Moe GW, Ezekowitz JA, et al. Can J Cardiol. 2013; 29:168-81.

12. Verma A, Cairns J, Mitchell B, et al. Can J Cardiol. 2014; 30 (10): 1114-30.

13. Yang E, Shah S, Criley JM. Am J Med. 2012; 125:337-43.

14. Budnitz DS, Lovegrove MC, Shehab N, et al. N Engl J Med. 2011; 365:2002-12.

Authors do not have any conflicts of interest to declare.