Interaction Between Digoxin and Dronedarone in the PALLAS Trial
Key result
In patients with permanent atrial fibrillation, concurrent digoxin use strongly exacerbated the adverse effect of dronedarone on cardiovascular death (HR 7.31; 95% CI 1.66-32.20; interaction P=0.01).
Why the study?
Does concurrent digoxin use increase the risk of cardiovascular death in patients with permanent atrial fibrillation treated with dronedarone?
Population
3,236 patients with permanent atrial fibrillation from the PALLAS trial, of whom 1,070 were receiving…
Comparison
Dronedarone vs Placebo
Design
RCT, Randomized, Placebo-controlled
Authors
Discussion
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Implication
Avoid dronedarone-digoxin combination in permanent AF; confirms interaction drives excess cardiovascular mortality.
Study Design
Type
RCT (n=3,236)
Randomization
randomized
Structured PICO
Does concurrent digoxin use increase the risk of cardiovascular death in patients with permanent atrial fibrillation treated with dronedarone?
P
Population
3,236 patients with permanent atrial fibrillation randomized to dronedarone or placebo, analyzed by baseline digoxin use.
I
Intervention
Dronedarone
C
Comparator
Placebo
O
Outcome
Cardiovascular deathhard clinical
Main Result
Hazard Ratio: 7.31 (95% CI 1.66–32.2)
Absolute Event Rate: 8.6% vs 1.2%
p-value: p=0.009
The increased risk of cardiovascular and arrhythmic death associated with dronedarone in patients with permanent atrial fibrillation is strongly driven by a drug-drug interaction with concurrent digoxin use.
Cite This Study
Hohnloser et al. (2014) conducted an RCT in permanent atrial fibrillation (n=3,236). Dronedarone vs. Placebo was evaluated on cardiovascular death in patients on digoxin (adjusted HR 7.31, 95% CI 1.66-32.20, p=0.009). In patients with permanent atrial fibrillation, concurrent digoxin use strongly exacerbated the adverse effect of dronedarone on cardiovascular death (HR 7.31; 95% CI 1.66-32.20; interaction P=0.01).