http://www.theheart.org/web_slides/1135499.do A placebo-controlled, double-blind, parallel-arm trial on ATHENA, using patients with moderate-to high-risk arterial fibrillation

1. ATHENA

2. ATHENA
SH Hohnloser (JW Goethe University, Frankfurt, Germany)
Heart Rhythm Society 2008 Scientific Sessions
• A placebo-controlled, double-blind, parallel-arm trial
• Population and treatment:
>4500 moderate- to high-risk atrial-fibrillation patients >75 years old or >70
if they had at least one CV risk factor (hypertension, diabetes, prior stroke or
TIA, an enlarged left atrium, or an LVEF <40%)
Randomized to dronedarone 400 mg twice daily or placebo
• End points:
Primary outcome: Prevention of CV hospitalization or death from any cause
Secondary outcomes: All-cause mortality, CV mortality, CV hospitalization,
death from cardiac arrhythmia, and cardiac nonarrhythmic death

3. ATHENA: Results
• 24% reduction with dronedarone vs placebo in risk of CV hospitalization or
death over almost two years
Hazard ratios for primary and secondary end points:
Dronedarone vs placebo*
End point Hazard ratio p
Time to first CV hospitalization or death from any cause 0.76 <0.001
All-cause mortality 0.84 NS
CV mortality 0.71 0.034
CV hospitalization 0.75 <0.001
Death from cardiac arrhythmia 0.55 0.01
Cardiac nonarrhythmic death 0.95 NS
*Mean follow-up of 21 months

4. ATHENA: Commentary*
"In ATHENA, for the first time, there's an antiarrhythmic drug for atrial fibrillation
that actually seems to reduce [cardiovascular] mortality. That's going to make it
very attractive, considering that other drugs when compared with placebo haven't
done that–with the possible exception of amiodarone, and that's debatable."
- Dr Brent L Mitchell
”The critical comparison should have been between dronedarone and amiodarone,
both because amiodarone is highly efficacious in this setting and because the
apparent goal in the development of dronedarone was to produce an agent that
would be as effective as amiodarone but have fewer side effects."
- Dr Michael D Ezekowitz
*All comments from Dronedarone safety, efficacy standings bolstered in huge atrial-fibrillation trial
(http://www.theheart.org/article/867591.do)

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