Interaction between digoxin and dronedarone in the PALLAS trial.
Publication/Presentation Date
12-1-2014
Abstract
BACKGROUND: Elevated serum digoxin concentration can cause toxicity, including death. Dronedarone increases digoxin concentration by P-glycoprotein interaction. In Permanent Atrial Fibrillation Outcome Study Using Dronedarone On Top Of Standard Therapy Trial (PALLAS), dronedarone was associated with both increased cardiovascular death and heart failure in patients with permanent atrial fibrillation. The present analysis examines whether the dronedarone-digoxin interaction might explain these adverse outcomes.
METHODS AND RESULTS: Subgroup analysis was performed to compare outcomes of patients on digoxin at baseline or not. In PALLAS, 1619 patients were randomized to dronedarone and 1617 to placebo, of whom 544 (33.6%) and 526 (32.5%) were receiving digoxin, respectively. Median (Q1,Q3) digoxin serum concentration on day 7 was 1.1 (0.7,1.5) ng/mL on dronedarone and 0.7 (0.5,1.1) ng/mL on placebo (P
CONCLUSIONS: In PALLAS, there was a strong effect of concurrent digoxin use on the adverse effect of dronedarone on cardiovascular death, but not on occurrence of heart failure.
CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01151137.
Volume
7
Issue
6
First Page
1019
Last Page
1025
ISSN
1941-3084
Published In/Presented At
Hohnloser, S. H., Halperin, J. L., Camm, A. J., Gao, P., Radzik, D., Connolly, S. J., & PALLAS investigators (2014). Interaction between digoxin and dronedarone in the PALLAS trial. Circulation. Arrhythmia and electrophysiology, 7(6), 1019–1025. https://doi.org/10.1161/CIRCEP.114.002046
Disciplines
Medicine and Health Sciences
PubMedID
25378467
Department(s)
Department of Medicine, Cardiology Division
Document Type
Article