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Dronedarone (DR) is the latest antiarrhythmic drug (AAD) approved to treat patients with atrial fibrillation. This retrospective cohort study evaluated cardiovascular (CV) outcomes associated with DR use compared to more established atrial fibrillation treatments in a “real-world” setting.
Data were extracted (July 2009-July 2011) from the United States Department of Defense Electronic Health Record database of >10 million patients. Based on first prescription, patients were included in 1 of 4 cohorts: DR, calcium channel blockers, other AADs (Class Ic/III) or digoxin. In this subanalysis, the population consisted of new initiators of DR and “other AADs”. All study initiators were required to have at least one year of history prior to the index date. To reduce selection bias, initiators of “other AADs” were propensity-score (PS) matched (2:1) to DR patients. Outcomes included CV hospitalizations, all-cause mortality and CV-related death.
Prior to PS matching, DR initiators (n = 3,020) were younger, had fewer diseases and used fewer medications during the baseline period versus “other AAD” initiators (n = 12,883). PS matching resulted in 2,079 DR patients and 4,158 “other AADs” patients with similar baseline characteristics. All-cause mortality was higher in the “other AADs” cohort compared with the DR initiators (0.7 vs 0.3%, respectively; hazard ratio = 2.28 [confidence interval (CI), 1.00-5.20; p < 0.05]). There were no differences in CV hospitalizations (8.4 vs 7.8%, respectively; hazard ratio = 1.16 [CI, 0.96-1.40; p = 0.117]) or CV-related death rates (both 0.1%; hazard ratio = 1.62 [CI, 0.17-15.6; p = 0.677]). For the latter parameter, the number of events was low (n = 3 and 1, respectively).
These findings are the first to describe CV outcomes associated with DR use in a real-world setting. DR use resulted in lower all-cause mortality compared with “other AADs,” with no increased risk of CV-related deaths/hospitalizations observed.
Poster Sessions, Expo North
Saturday, March 09, 2013, 10:00 a.m.-10:45 a.m.
Session Title: Arrhythmias: Basic Science and Atrial Fibrillation
Abstract Category: 5. Arrhythmias: Basic
Presentation Number: 1106-45
- 2013 American College of Cardiology Foundation