"We are very pleased that these two large studies were positive and consistent in showing that dronedarone significantly reduced the recurrence of atrial fibrillation and flutter compared to placebo," says Bramah Singh, M.D., VA Medical Center West LA, David Geffen School of Medicine, University of California Los Angeles, and lead investigator of the trials.
In both studies, dronedarone also significantly reduced the ventricular rate during arrhythmia recurrence, a secondary endpoint. This therapeutic effect is also referred to as rate control, which consists of reducing the heart rate.
"Rate control is a very interesting feature of dronedarone and compliments the anti-arrhythmic effects of the drug," says Dr. Singh. "Rate control has been established to reduce symptoms."
A post-hoc analysis also showed that in the combined studies, dronedarone significantly reduced the rate of the combined end point of hospitalization or death compared to placebo. This important finding is being prospectively explored in an ongoing morbidity and mortality trial.
In the dronedarone arm of the studies, no episodes of "torsades de
pointes," a serious ventricular arrhythmia observed with some existing
treatments, were reported at one year and the incidence of adverse events
(pulmonary toxicity, thyroid and liver dysfunction) was not significantly
increased. In both studies, hyperthyroidism occurred less frequently in the
dronedarone group versus placebo (8.4% vs 14.1%, P=0.0024) and elevated
serum creatinine concentrations, which in some cases were reversible,
occurred more frequently in the dronedarone group versus placebo (2.4% vs
0.2%, P=0.0039) without impact on renal function. Most common adverse
events occurring in more than two percent of dronedarone treated patients,
not statistically different from placebo, included cough, dyspnoea,
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