Badanie ATHENA – ocena wpływu dronedaronu na incydenty sercowo-naczyniowe u chorych z migotaniem przedsionków Discussion

Abstract

Dronedarone is a new antiarrhythmic agent that is being currently investigated in patients with atrial fibrillation. In the ATHENA study (A Placebo – Controlled, Double – Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in Patients with Atrial Fibrillation/Atrial Flutter) the evaluation of the use of dronedarone in patients with atrial fibrillation and additional risk factors was performed. The 4628 people were randomly assigned to receive dronedarone, 400 mg twice a day, or placebo. The primary end points were: the first hospitalization due to cardiovascular events or death. Secondary outcomes: death from any cause, death from cardiovascular reasons, hospitalization due to cardiovascular events. The mean follow-up period was 21 months. The study was prematurely finished in 696 of the 2301 patients receiving the drug and in 716 of the 2327 patients receiving placebo, mainly due to side effects. The primary end point occurred in 734 patients in the dronedarone group and in 917 patients in placebo group (p <0,001). There were 116 deaths in patients actively treated and in 139 receiving placebo (p=0,18). There were 63 cardiovascular deaths in the dronedarone group and 90 in the placebo group (p=0,03), mostly because of a reduction in the rate of death caused by arrhythmia. Bradycardia, QT – interval prolongation, nausea, diarrhea, rash and increased serum creatinine level were the most frequent adverse events of dronedarone. The rate of pulmonary or thyroid – related side effect were not significantly different between the groups. In patients with atrial fibrillation dronedarone reduced the incidence of hospitalization due to cardiovascular events or death.