Researchers, led by Yehuda Handelsman, conducted a post-hoc analysis of the ATHENA and EURIDIS/ADONIS studies and concluded that dronedarone reduced cardiovascular hospitalization/death and atrial fibrillation/atrial flutter recurrence and increased time to recurrence event in patients both with and without diabetes. Their study was published in the Journal of Diabetes and Its Complications.
This analysis focused on the patients who had diabetes, 945 of 4628 patients in ATHENA (dronedarone = 482; placebo = 463) and 215 of 1237 patients in EURIDIS/ADONIS (dronedarone = 148; placebo = 67). Patients were stratified based on baseline diabetes status. Time-to-event was assessed using the Kaplan-Meier method, and hazard ratios were estimated via Cox models.
According to the researchers, there were higher rates of cardiovascular hospitalization/death in patients with diabetes (39.5%) than in those without diabetes (34.7%). The incidence of first cardiovascular hospitalization/death was lower in patients with diabetes treated with dronedarone (35.1%) compared with placebo (44.1%), and the time to that event was longer in patients treated with dronedarone compared with placebo (P=.005).
Dronedarone in Atrial Fibrillation With Diabetes
Additionally, the median atrial fibrillation/atrial flutter recurrence time was longer with dronedarone compared with placebo in patients with diabetes (ATHENA = 722 vs. 527 days, P=.004; EURIDIS/ADONIS = 100 vs. 23 days; P=.15) and without diabetes (ATHENA = 741 vs. 492 days; P<.0001; EURIDIS/ADONIS = 120 vs. 59 days; P=.0002). Finally, the rate of treatment-related adverse events with dronedarone was comparable to placebo in patients with and without diabetes.
The researchers noted that the analysis was limited by the lack of data on blood glucose levels in the ATHENA study and whether or not diabetes treatments were changed during either study. Analysis was also limited by the differing diagnosis of diabetes between the 2 trials.
The investigators concluded that “dronedarone demonstrated similar efficacy in reducing cardiovascular hospitalization rates, delaying time to first cardiovascular hospitalization and death, and reducing atrial fibrillation/atrial flutter recurrence in atrial fibrillation/atrial flutter patients with or without diabetes with a comparable safety profile relative to placebo.”
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