Hospital Ana Nery

Digoxin was approved for heart failure treatment in 1998 according to current regulations made by Food and Drug Administration (FDA), based on the following clinical trials: The Prospective and Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED), Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme (RADIANCE) and Digitalis Investigation Group (DIG). Also, it was approved for the control of ventricular response rate in atrial fibrillation patients.
Several clinical trials with digoxin provided convincing evidence that support the digoxin use heart failure (HF) treatment of symptomatic patients. PROVED trial was a placebo-controlled, twelve weeks duration study. This study included patients with decreased systolic function, sinus rhythm and heart failure stable symptoms, these patients were using digoxin and diuretics. Patients whom digoxin was removed presented a twice heart failure worsen, reduction of exercise capacity and also a reduction of left ventricle ejection fraction, in comparison to patients that kept the digoxin therapy. The study RADIANCE followed a similar protocol; however the patients used ACE inhibitors besides digoxin and diuretics. The digoxin removal was associated with a six times worsen of heart failure, despite the maintenance of ACE inhibitors and diuretics. There was a worsening in the functional capacity, life quality and in the ejection fraction on the digoxin removal patients' group.