Low-dose digoxin did not significantly reduce the composite endpoint of total worsening heart failure events or cardiovascular mortality compared to placebo (Rate ratio 0.81).
RCT (n=1,001)
Double-blind
1:1
Yes
Does low-dose digoxin reduce the composite of total worsening heart failure events and cardiovascular mortality in patients with heart failure with reduced or mildly reduced ejection fraction?
In patients with HFrEF or HFmrEF, the addition of low-dose digoxin to contemporary guideline-directed medical therapy did not significantly reduce the composite of total worsening heart failure events and cardiovascular mortality.
Effect estimate: Rate ratio 0.81 (95% CI 0.61-1.07)
Absolute Event Rate: 15.7% vs 19.3%
p-value: p=0.133
“the results will determine whether the reevaluation applies to all members of this therapeutic class or only to digitoxin”
A meta-analysis including this trial, suggesting low-dose digoxin reduces heart failure hospitalizations by 25%, has sparked widespread news coverage and discussion about reviving an old, inexpensive drug in modern heart failure therapy.
Veldhuisen et al. (Sun,) conducted a rct in Heart failure with reduced or mildly reduced ejection fraction (n=1,001). Digoxin vs. Placebo was evaluated on Composite of total worsening heart failure events (total hospitalizations or urgent visits) and cardiovascular mortality (Rate ratio 0.81, 95% CI 0.61-1.07, p=0.133). Low-dose digoxin did not significantly reduce the composite endpoint of total worsening heart failure events or cardiovascular mortality compared to placebo (Rate ratio 0.81).