Abstract 2753: Safety and Efficacy of Dronedarone for the Prevention of Recurrent Atrial Fibrillation: A Meta-analysis
Background: Dronedarone is a newer agent for the treatment of Atrial Fibrillation (AF). Controversy persists regarding the safety and efficacy of dronedarone in the prevention of recurrent AF. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the safety and efficacy of dronedarone in the prevention of recurrent atrial AF.
Methods: We performed a systematic literature search for randomized controlled trials using dronedarone versus placebo in the prevention of recurrent AF. Clinical trials providing data on the outcome of recurrent AF or adverse events were included. Statistical heterogeneity across the various trials was tested using the Cochran’s Q statistic and I2 was computed to quantify heterogeneity. A two-sided alpha error of less than 0.05 was considered to be statistically significant (p < 0.05).
Results: Five trials provided data on the adverse events and 4 provided data on the outcome of AF. The studies were heterogeneous, hence the Mantel-Haenszel random-effect model was used to calculate combined relative risk (RR). Meta-analysis revealed that dronedarone, as compared to placebo, was effective in preventing recurrence of AF (RR, 0.596; 95% CI, 0.432 to 0.822; p = 0.002). Also, compared to placebo there were no significant adverse effects in dronedarone group (RR, 1.102; 95% CI, 0.986 to 1.321; p = 0.087). (See Figures⇓ below).
Conclusion: Dronedarone, as compared with placebo, was associated with a significant reduction in the incidence of recurrent atrial fibrillation without significant adverse effects.