Related Experiment Videos
The effect of digoxin on mortality and morbidity in patients with heart failure
Insights
Digoxin did not impact overall mortality in chronic heart failure patients. However, digoxin significantly reduced hospitalizations for worsening heart failure and overall, clarifying its role in treatment.
Area of Science:
- Cardiology
- Pharmacology
Background:
- The efficacy of cardiac glycosides, specifically digoxin, in managing chronic heart failure (CHF) with normal sinus rhythm is debated.
- Previous studies have yielded conflicting results regarding digoxin's impact on mortality and hospitalization rates in CHF patients.
Purpose of the Study:
- To investigate the effect of digoxin on mortality and hospitalization in patients with chronic heart failure and normal sinus rhythm.
- To clarify the precise role of digoxin in the contemporary management of CHF.
Main Methods:
- A randomized, double-blind clinical trial was conducted involving patients with left ventricular ejection fraction ≤0.45.
- Patients received either digoxin or placebo, in addition to standard care (diuretics and ACE inhibitors), with a median follow-up of 37 months.
- An ancillary trial assessed patients with ejection fraction >0.45.
Main Results:
- Digoxin did not significantly alter overall mortality rates in the main trial (34.8% vs. 35.1%).
- A trend towards reduced deaths from worsening heart failure was observed (Risk Ratio 0.88, P=0.06).
- Digoxin significantly decreased overall hospitalizations by 6% and hospitalizations for worsening heart failure (26.8% vs. 34.7%, P<0.001).
Conclusions:
- Digoxin does not reduce overall mortality in patients with chronic heart failure and normal sinus rhythm.
- Digoxin effectively reduces hospitalization rates, both overall and specifically for worsening heart failure.
- These findings refine the established indications for digoxin in CHF management.
Background:
The role of cardiac glycosides in treating patients with chronic heart failure and normal sinus rhythm remains controversial. We studied the effect of digoxin on mortality and hospitalization in a randomized, double-blind clinical trial.
Methods:
In the main trial, patients with a left ventricular ejection fraction of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and angiotensin-converting-enzyme inhibitors (median dose of digoxin, 0.25 mg per day; average follow-up, 37 months). In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo.
Results:
In the main trial, mortality was unaffected. There were 1181 deaths (34.8 percent) with digoxin and 1194 deaths (35.1 percent) with placebo (risk ratio when digoxin was compared with placebo, 0.99; 95 percent confidence interval, 0.91 to 1.07; P=0.80). In the digoxin group, there was a trend toward a decrease in the risk of death attributed to worsening heart failure (risk ratio, 0.88; 95 percent confidence interval, 0.77 to 1.01; P=0.06). There were 6 percent fewer hospitalizations overall in that group than in the placebo group, and fewer patients were hospitalized for worsening heart failure (26.8 percent vs. 34.7 percent; risk ratio, 0.72; 95 percent confidence interval, 0.66 to 0.79; P<0.001). In the ancillary trial, the findings regarding the primary combined outcome of death or hospitalization due to worsening heart failure were consistent with the results of the main trial.
Conclusions:
Digoxin did not reduce overall mortality, but it reduced the rate of hospitalization both overall and for worsening heart failure. These findings define more precisely the role of digoxin in the management of chronic heart failure.