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ATHENA Trial (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) Presented at Heart Rhythm 2008 in San Francisco, USA Presented by Stefan H. Hohnloser, MD ATHENA Trial Copyleft Clinical Trial Results. You Must Redistribute Slides
ATHENA Trial: Background ,[object Object],[object Object],[object Object],JCE 2008; 19.1/Heart Rhythm 2008
[object Object],[object Object],ATHENA Trial: Dronedarone JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Study Design ,[object Object],[object Object],Multaq ®  (dronedarone) 400 mg BID Placebo 4,628 patients  > 75 years with atrial fibrillation or 70-75 years with atrial fibrillation and at least one additional cardiovascular risk factor prior to randomization.  Double blind. Randomized. Placebo controlled. International multicenter. Mean follow-up 21 months.  JCE 2008; 19.1/Heart Rhythm 2008 R 12-30 mos. follow-up Copyleft Clinical Trial Results. You Must Redistribute Slides
ATHENA Trial: Inclusion Criteria ,[object Object],[object Object],JCE 2008; 19.1/Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides
ATHENA Trial: Inclusion Criteria Cont. ,[object Object],[object Object],JCE 2008; 19.1/Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides
ATHENA Trial: Exclusion Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Exclusion Criteria cont. ,[object Object],[object Object],[object Object],[object Object],[object Object],Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Exclusion Criteria cont. ,[object Object],[object Object],[object Object],Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Baseline Characteristics JCE 2008; 19.1 /Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides *AF at baseline: according to the stratification factor at randomization. Characteristic Incidence/Mean Value Patient age <65 years 19% 65-74 years  40% ≥ 75 years 42% Female gender 47% Hypertension 86% Mean systolic blood pressure 134 mmHg AF at baseline* 25% History of cardioversion 34%
ATHENA Trial: Baseline Characteristics JCE 2008; 19.1/Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides **Structural heart disease: coronary heart disease and/or ischemic dilated cardiomyopathy and/or nonischemic dilated  cardiomyopathy and/or rheumatic valvular heart disease and/or nonrheumatic valvular heart disease and/or hypertrophic  cardiomyopathy and/or history of congestive heart failure and/or left ventricular ejection fraction (LVEF) < 45%. Characteristic Incidence/Mean Value Structural heart disease** 60% -History of coronary artery disease 30% -Ischemic dilated cardiomyopathy  5% -Nonischemic dilated cardiomyopathy 4% -Rheumatic valve disease 2% -Nonrheumatic valve disease 15%
ATHENA Trial: Baseline Characteristics JCE 2008; 19.1/Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides ***Lone atrial fibrillation: patients without hypertension and without structural heart disease. Characteristic Incidence/Mean Value Structural heart disease cont.** 60% - Hypertrophic cardiomyopathy 2% - History of congestive heart failure 29% - LVEF < 0.45 12% Lone atrial fibrillation*** 6%
ATHENA Trial: Primary Endpoint Results ,[object Object],Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Secondary Endpoint Results ,[object Object],[object Object],[object Object],Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Other Outcomes ,[object Object],[object Object],[object Object],Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Adverse Events ,[object Object],Gastro-intestinal Effects  (%) Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Adverse Events ,[object Object],Skin disorders (mainly rash)  (%) Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Adverse Events ,[object Object],Increased Blood Creatinine  (%) Copyleft Clinical Trial Results. You Must Redistribute Slides JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Limitations ,[object Object],[object Object],JCE 2008; 19.1/Heart Rhythm 2008
ATHENA Trial: Summary ,[object Object],[object Object],JCE 2008; 19.1/Heart Rhythm 2008

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Athena

  • 1. ATHENA Trial (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) Presented at Heart Rhythm 2008 in San Francisco, USA Presented by Stefan H. Hohnloser, MD ATHENA Trial Copyleft Clinical Trial Results. You Must Redistribute Slides
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  • 10. ATHENA Trial: Baseline Characteristics JCE 2008; 19.1 /Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides *AF at baseline: according to the stratification factor at randomization. Characteristic Incidence/Mean Value Patient age <65 years 19% 65-74 years 40% ≥ 75 years 42% Female gender 47% Hypertension 86% Mean systolic blood pressure 134 mmHg AF at baseline* 25% History of cardioversion 34%
  • 11. ATHENA Trial: Baseline Characteristics JCE 2008; 19.1/Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides **Structural heart disease: coronary heart disease and/or ischemic dilated cardiomyopathy and/or nonischemic dilated cardiomyopathy and/or rheumatic valvular heart disease and/or nonrheumatic valvular heart disease and/or hypertrophic cardiomyopathy and/or history of congestive heart failure and/or left ventricular ejection fraction (LVEF) < 45%. Characteristic Incidence/Mean Value Structural heart disease** 60% -History of coronary artery disease 30% -Ischemic dilated cardiomyopathy 5% -Nonischemic dilated cardiomyopathy 4% -Rheumatic valve disease 2% -Nonrheumatic valve disease 15%
  • 12. ATHENA Trial: Baseline Characteristics JCE 2008; 19.1/Heart Rhythm 2008 Copyleft Clinical Trial Results. You Must Redistribute Slides ***Lone atrial fibrillation: patients without hypertension and without structural heart disease. Characteristic Incidence/Mean Value Structural heart disease cont.** 60% - Hypertrophic cardiomyopathy 2% - History of congestive heart failure 29% - LVEF < 0.45 12% Lone atrial fibrillation*** 6%
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