Sanofi-Aventis presents positive data from atrial fibrillation trial

In this new analysis, dronedarone significantly reduced the total number of hospital days by 28% (p<0.001) versus placebo (9,995 days versus 13,986 days), and decreased by 35% (p<0.001) the total length of time spent in hospital for cardiovascular reasons (5,875 days versus 9,073 days). In addition to the demonstrated reduction of atrial fibrillation (AF)-related hospitalization by 37% (p<0.001), dronedarone reduced the incidence of first non-AF related CV hospitalization (myocardial infarction or unstable angina) by 14% (p=0.016). Dronedarone did not increase the incidence of non-cardiovascular hospitalizations in comparison to the placebo arm, the company said. A second post-hoc analysis from Athena, also confirmed the rhythm and rate controlling properties of dronedarone, already previously demonstrated in lower risk populations studied in the Euridis, Adonis and Erato trials. This analysis showed that dronedarone reduced the incidence of first AF recurrence by 25% in patients in sinus rhythm at study initiation (p<0.001), and the incidence of first electrical cardioversion by 31% (p<0.001), compared with placebo. According to the company, dronedarone also decreased mean heart rate during atrial fibrillation to 78 beats per minute, compared with 87 for placebo (p<0.001). Fewer patients developed permanent atrial fibrillation during the study in the dronedarone group – 178 patients (7.7%) compared with 295 patients (12.7%) in the placebo arm (p<0.001). In these patients, the non-significant reduction of CV hospitalization or death was 26% lower for those receiving dronedarone (p=0.096). In the Athena trial, compared to placebo, dronedarone showed a low risk of pro-arrhythmia and no excess of hospitalizations for congestive heart failure, the company said.