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ATHENA trial - Summary & Results

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A placebo-controlled, double-blind, parallel-arm trial on ATHENA, using patients with moderate-to high-risk arterial fibrillation

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ATHENA trial - Summary & Results

  1. 1. ATHENA
  2. 2. ATHENASH 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. 3. ATHENA: Results• 24% reduction with dronedarone vs placebo in risk of CV hospitalization or death over almost two yearsHazard 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. 4. ATHENA: Commentary*"In ATHENA, for the first time, theres an antiarrhythmic drug for atrial fibrillationthat actually seems to reduce [cardiovascular] mortality. Thats going to make itvery attractive, considering that other drugs when compared with placebo haventdone that–with the possible exception of amiodarone, and thats 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 theapparent goal in the development of dronedarone was to produce an agent thatwould 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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