15. What are the key learnings from the ATHENA study?

ATHENA is the first and only AF/AFL clinical drug trial that showed a reduction of cardiovascular hospitalisations or death from any cause by a statistically significant 24 percent (p=0.00000002). This positions it as a landmark trial. ATHENA has been published on February 12th 2009. (Hohnloser SH et al. N Engl J Med 2009;360:668-78).

ATHENA shows a reduction in the need for cardiovascular hospitalisations with potential impact on more than 6 million AF/AFL patients worldwide in providing a better quality of life.
Dronedarone is the first drug that has demonstrated a significant decrease in cardiovascular mortality, including cardiac arrhythmic death, in AF/AFL patients. In addition, ATHENA provided extensive confirmation of the overall good safety and tolerability profile of dronedarone, associated with a low risk of proarrhythmia or organ toxicity.

If approved, dronedarone would set a new step forward for evaluating the therapeutic effect of a drug for the treatment of patients with atrial fibrillation, and a new advance in the management of AF, overcoming the rhythm versus rate historical debate.