"Mortality and Hospitalization in Heart Failure Patients on Digoxin".
The New England Journal of Medicine. Year Not Provided. Volume(Issue):Page Numbers Not Provided.
PubMed • Full text • PDF

Contents

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcomes
8.2 Secondary Outcomes
9 Funding
10 Further Reading

Clinical Question

Does digoxin therapy affect overall mortality and rate of hospitalization in patients with chronic heart failure and normal sinus rhythm?

Bottom Line

Digoxin therapy did not reduce overall mortality in patients with chronic heart failure but was associated with a reduced rate of hospitalization both overall and for worsening heart failure, more precisely defining the role of digoxin in chronic heart failure management.

Major Points

Despite digoxin being widely prescribed for heart failure treatment, uncertainties persisted about its long-term safety and efficacy. The study aimed to assess digoxin's impact on mortality and hospitalization over 3 to 5 years in patients with heart failure and normal sinus rhythm.

Guidelines

Not addressed in the provided article.

Design

Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial.

Population

In the main trial, patients had a left ventricular ejection fraction of 0.45 or less, while in the ancillary trial, patients possessed ejection fractions greater than 0.45.

Inclusion Criteria
Chronic heart failure, left ventricular ejection fraction ≤0.45 for main or >0.45 for ancillary trial, normal sinus rhythm.

Exclusion Criteria
Not specified in the provided excerpt.

Baseline Characteristics
No significant differences between digoxin and placebo groups.

Interventions

Patients were randomized to receive digoxin or placebo alongside diuretics and angiotensin-converting-enzyme inhibitors.

Outcomes

Primary Outcomes
In the primary trial, no significant difference in overall mortality between digoxin and placebo groups.

Secondary Outcomes
In digoxin group compared to placebo: Fewer hospitalizations for worsening heart failure; trend toward a decrease in risk of death attributed to heart failure; reduction in hospitalizations for cardiovascular causes; increased suspected digoxin toxicity resulted in hospitalization (but low overall).

Funding

The trial was organized and conducted by a Steering Committee representing various institutions, with the drug and placebo supplied by Glaxo Wellcome.

Further Reading

Details not provided.