BACKGROUND: This review summarizes the current status of randomized trials of digitalis in treating patients with congestive heart failure who are in sinus rhythm. Methods and results Randomized double-blind placebo-controlled trials of 20 or more adult patients followed for 7 weeks or more were selected. We identified 13 trials that met the inclusion criteria, comprising a total of 7896 patients. Of this number, 7755 patients contributed to information on mortality, 7262 to information on hospitalization for worsening heart failure, and 1096 to information on clinical status. Patients treated with digitalis compared with placebo had an odds ratio and confidence intervals for mortality of 0.98 (0.89, 1.09), for hospitalization of 0.68 (0.61, 0.75), and for a lesser degree of deterioration in clinical status of 0.31 (0.21, 0.43). CONCLUSIONS: The literature indicates that the drug has no effect on long-term mortality, but reduces the incidence of hospitalization, and has a positive effect on the clinical status of symptomatic patients. The drug has beneficial effects in patients who remain symptomatic despite being appropriately treated with diuretics and angiotensin-converting enzyme inhibitors. However the effects of coadministration with beta-blockers, spironolactone, and valsartan remain uncertain.
BACKGROUND: This review summarizes the current status of randomized trials of digitalis in treating patients with congestive heart failure who are in sinus rhythm. Methods and results Randomized double-blind placebo-controlled trials of 20 or more adult patients followed for 7 weeks or more were selected. We identified 13 trials that met the inclusion criteria, comprising a total of 7896 patients. Of this number, 7755 patients contributed to information on mortality, 7262 to information on hospitalization for worsening heart failure, and 1096 to information on clinical status. Patients treated with digitalis compared with placebo had an odds ratio and confidence intervals for mortality of 0.98 (0.89, 1.09), for hospitalization of 0.68 (0.61, 0.75), and for a lesser degree of deterioration in clinical status of 0.31 (0.21, 0.43). CONCLUSIONS: The literature indicates that the drug has no effect on long-term mortality, but reduces the incidence of hospitalization, and has a positive effect on the clinical status of symptomatic patients. The drug has beneficial effects in patients who remain symptomatic despite being appropriately treated with diuretics and angiotensin-converting enzyme inhibitors. However the effects of coadministration with beta-blockers, spironolactone, and valsartan remain uncertain.