Digoxin use in congestive heart failure. Current status.

The use of digitalis in congestive heart failure with normal sinus rhythm is still debated. While older uncontrolled, withdrawal studies from 1969 to 1983 provided incomplete data, with poorly documented clinical status and poor haemodynamic and exercise data, some patients did improve clinically when digitalis treatment was utilised. Randomised, double-blind, placebo-controlled trials from 1977 to 1991 were of better quality but still short in duration, with small sample sizes and still with incomplete haemodynamic and exercise data. In 1993, the Prospective Randomised Study of Ventricular Failure and Efficacy of Digoxin (PROVED) and Randomised Assessment of Digoxin on Inhibitors of the Angiotensin-Converting Enzyme (RADIANCE) study, followed in 1997 by the Digitalis Investigation Group (DIG) trial, documented that digoxin prevents clinical deterioration and hospitalisations, and improves exercise tolerance and left ventricular function, but has no effect on survival. A substudy of the DIG trial showed no detrimental effect of digoxin on survival in patients with ejection fraction (EF) of > 45%, i.e. left ventricular (LV) diastolic dysfunction. Therefore, digoxin appears to be the first inotrope with no detrimental effect on survival in heart failure. In addition, the neurohormonal effect of digoxin has been documented, and is possibly present with dosages even lower than 0.25 mg. Finally, it has been determined that patients with only mild heart failure do obtain documented benefit from administration of this drug.

RCT Entities:   Population Interventions Outcomes